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Less pain with Biatain–Ibu:initial findings from arandomised, controlled, double-blind clinical investigation onpainful venous leg ulcersFinn Gottrup, Bo Jørgensen, Tonny Karlsmark, R Gary Sibbald, RytisRimdeika, Keith Harding, Patricia Price, Vanessa Venning, Peter Vowden,Michael Junger, Stephan Wortmann, Rita Sulcaite, Gintaris Vilkevicius,Terttu-Liisa Ahokas, Karel Ettler, Monika Arenbergerova

Gottrup F, Jørgensen B, Karlsmark T, Sibbald RG, Rimdeika R, Harding K, Price P, Venning V, Vowden P, Junger M,Wortmann S, Sulcaite R, Vilkevicius G, Ahokas T-L, Ettler K, Arenbergerova M. Lower pain with Biatain–Ibu:a randomised, controlled, double-blind clinical investigation on painful venous leg ulcers. Int Wound J2007;4 (Suppl. 1):24–34.

ABSTRACTSix out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicentre,randomised, double-blind clinical investigation of 122 patients compared two moist wound-healing dressings,a non adhesive foam dressing with ibuprofen (62 patients randomised to Biatain-Ibu non adhesive, Coloplast A/S)with a non adhesive foam without ibuprofen (60 to Biatain non adhesive).The ibuprofen-foam was regardedsuccessful, if the pain relief on a 5-point verbal rating scale was higher than the comparator withoutcompromising safety, including appropriate healing rate. Additional endpoints were change in persistent woundpain between dressing changes and pain at dressing change on days 1–5 and days 43–47. The primary responsevariable, persistent pain relief, was significantly higher in the ibuprofen-foam group compared with thecomparator on days 1–5, with a quick onset of action (P 0�05). The patients in the ibuprofen-foam group had asignificant (P 0�05) higher reduction in the persistent wound pain from baseline (40%) as the comparator (30%).

Authors: F Gottrup, MD DMSc, University Centre for Wound Healing, Odense University Hospital, Odense, Denmark, and CopenhagenWound Healing Centre, H:S Bispebjerg University Hospital, Copenhagen, Denmark; B Jørgensen, MD, Copenhagen Wound HealingCentre, H:S Bispebjerg University Hospital, Copenhagen, Denmark; T Karlsmark, MD, Copenhagen Wound Healing Centre, H:SBispebjerg University Hospital, Copenhagen, Denmark; RG Sibbald, MD, Wound Healing Clinic, Women’s College Hospital, University ofToronto, Toronto, Ontario, Canada; R Rimdeika, MD, Department of Plastic and Reconstructive Surgery, Kaunas University of Medicine,Kaunas, Lithuania; K Harding, MB MRCGP FRCS, Wound Healing Research Unit, Cardiff University, Heath Park, Cardiff, UK; P Price, PhD,Wound Healing Research Unit, Cardiff University, Heath Park, Cardiff, UK; V Venning, DM FRCP, Department of Dermatology, TheChurchill Hospital, Oxford, UK; P Vowden, MD, Department of Vascular Surgery, Penthouse, Bradford Royal Infirmary, Bradford, UK;M Junger, MD, Klinik und Poliklinik fur Hautkrankheiten, Ernst-Moritz-Arndt University of Greifswald, Greifswald, Germany; S Wortmann,Dr Med, Facharzt fur Dermatologie, Gesundheitszentrum, Blaubeuren, Germany; R Sulcaite, MD PhD, Institute of Endocrinology, KaunasUniversity of Medicine, Kaunas, Lithuania; G Vilkevicius, MD PhD, Department of Vasculosurgery, Vilnius University Antakalnio Hospital,Antakalnio Vilnius Lt-10200, Lithuania; T-L Ahokas, MD, HUS, Iho-ja allergiasairaala, Ihotautien klinikka, Meilahdentie 2, PL 160, 00029HUS, Finland; K Ettler, MD PhD, Department of Dermatology, Sokolska 581, Building 22, Hradec Kralove, Czech Republic;M Arenbergerova, MD PhD, Department of Dermatology, Charles University 3rd School of Medicine, Srobarova 50, Prague, Czech RepublicAddress for correspondence: Dr F Gottrup, University Centre for Wound Healing, Odense University Hospital, Sdr. Boulevard 29,DK–5000 Odense C, Denmark; and Copenhagen Wound Healing Centre, H:S Bispebjerg University Hospital, Bispebjerg Bakke 23 DK-2400 Copenhagen, DenmarkE-mail: fgottrup@post4.tele.dk

CLINICAL RESEARCH

24 ª 2007 The Authors. Journal Compilation ª 2007 Blackwell Publishing Ltd and Medicalhelplines.com Inc • International Wound Journal • Vol 4 (Suppl. 1) No 1

Women reported less pain intensity than men, and pain intensity decreased with increasing age. In addition, painintensity increased with increasing initial pain intensity and increasing wound size. Wound healing was similar inthe ibuprofen-foam group to that of the comparator group. No difference in adverse events between placebo andlocal sustained release of low-dose ibuprofen was observed in this study. This study has demonstrated that theibuprofen-foam dressing provided pain relief and reduced pain intensity without compromising healing or othersafety parameters. The full report of this study will be published in Wound Repair and Regeneration.

Key words: Fast wound healing • Topical treatment • Wound pain relief • Wound pain intensity reduction

INTRODUCTIONDespite the fact that six out of ten people with

chronic wounds suffer from persistent wound

pain (1–3), little is known about the effective-

ness of local treatment interventions (4) for

persistent pain between dressing changes.

Persistent pain associated with non healing

wounds is caused by tissue (nociceptive) or

nerve (neuropathic) damage and is influenced

by dressing changes and chronic inflamma-

tion. Chronic wounds take long time to heal,

and patients can suffer from chronic wounds

for many years (5). Chronic wound healing

may be compromised by coexisting underlying

conditions, such as peripheral vascular disease,

uncontrolled oedema and diabetes mellitus.

The pain from chronic wounds can be

extremely severe, causing both physical and

mental debilitation. Patients can become im-

mobile, which in turn can lead to social isola-

tion, depression and feelings of hopelessness

(5). The pain experienced by persons with

chronic wounds has been described as a red

raw (feeling), burning and like having acid

thrown onto the skin (5).

The application of compression bandaging is

generally accepted to improve venous ulcer

healing; however, in many cases, patients with

chronic venous ulceration find it difficult to

tolerate high-compression bandaging (44%)

because of associated pain (6), and this will

adversely affect ulcer healing. In general,

wound pain is reported to reduce appetite

(7), reduce mobility, induce loneliness (8) and

disturb sleeping (9). All these factors lead to

a general decrease in health, which is a barrier

to wound healing.

This investigation compares the perfor-

mance and safety of a non adhesive foam

dressing with ibuprofen (ibuprofen-foam) with

a foam non adhesive dressing alone (compar-

ator). The aim of this clinical investigation was

to investigate whether the ibuprofen-foam

dressing relieves venous ulcer pain without

compromising the beneficial properties of

moist wound healing, with an acceptable

safety profile.

MATERIALS AND METHODS

DesignThis randomised, controlled, double-blind,

parallel group, multicentre, and multinational

clinical investigation was conducted according

to the international standards of good clinical

practice. The primary outcome was to investi-

gate the pain-relieving effect of the ibuprofen-

foam, together with monitoring safety. The

study compared three investigation periods,

days 1–5, days 6–42 and days 43–47 (Figure 1).

On days 1–5 and days 6–42, the patients were

randomised 1:1 to either the ibuprofen-foam

group or the comparator group using pre-

made, treatment-coded envelopes. On days

43–47, the treatment was blinded only to the

patients, and all patients were crossed over

Study Phase: Effect/Safety Safety Follow-up

Painassessment

Biatain-Ibu

Painassessment

Day 1 – 5 43 – 47

Biatain

6 – 42

Compression

Biatain

Figure 1. The patients were in two groups. On days 1–5 and on days 43–47, pain intensity was assessed on a numeric box scale

and pain relief on a verbal rating scale.

Key Points

• 6 out of 10 people with chronic

wounds suffer from persistent

pain

• the aim of this clinical investi-

gation was to find out whether

the ibuprofin-foam dressing re-

lieves venous ulcer pain without

compromising the beneficial

properties of moist wound heal-

ing, with an acceptable safety

profile

Double-blind comparison with a pain relieving dressing

ª 2007 The Authors. Journal Compilation ª 2007 Blackwell Publishing Ltd and Medicalhelplines.com Inc 25

and treated with the comparator dressing. The

dressings were changed on a regular 48-hour

interval to ensure a uniform dressing environ-

ment (absorption, retention, release).

Patient characteristicsIndependent ethic boards for each study site

have approved this study according to inter-

nationally approved standards. The recruited

patients had received both oral and written

information about the study, and signed

consent. The study subjects were older than

18 years of age with painful chronic venous leg

ulcer of more than 8-week duration, and they

were required to receive compression therapy

for at least 2 weeks before inclusion, and

throughout the study period. The ulcer was

required to have a minimum length of 1�6 cm

in any direction, and a maximum area of 50

cm2. The minimum leg ulcer pain score at

inclusion was moderate on a 5-point verbal

rating scale (VRS) (none, slight, moderate, lots,

complete). Exclusion criteria included painful

ulcers that had been resistant to analgesic

treatment over the past 6 months or more,

pregnant or lactating women, clinical infection

(erysipelas and cellulitis) or critical colonisa-

tion (local infection) within or surrounding the

study ulcer, vasculitis, allergy or other contra-

indication to ibuprofen or other related an-

algesics (including known hypersensitivity to

acetylsalicylic acid or related non steroidal

anti-inflammatory agents especially associated

with a history of asthma, rhinitis or urticaria),

diabetes, the use of unscheduled additional

pain medication for 3 days prior to study ad-

mission (regular concomitant pain medication

was acceptable for inclusion), concomitant

treatment with systemic antibiotics other than

nitrofurantoin, concomitant treatment with sys-

temic corticosteroids (more than 10 mg/day

of prednisolone or equivalent), treatment with

other immunosuppressant or cancer chemother-

apeutic agents within 1 month prior to inclu-

sion, concomitant participation in other studies

and previous participation in this study.

The study participants were allowed to take

concomitant pain medication during the study,

but the medication had to be constant at days

1–5 and at days 43–47 when pain was assessed.

AssessmentsPersistent (chronic) and temporary pain (dress-

ing change related) was assessed on days 1–5

and on days 43–47 (Figure 1). The persistent

pain was rated in the morning and evening by

the patients between dressing changes, using

a diary. The persistent pain was rated on a pain

relief 5-point VRS (0 ¼ no relief, 1 ¼ slight

relief, 2 ¼ moderate relief, 3 ¼ lots of relief, 4 ¼

complete relief). Pain relief was regarded as

a retrospective view of the treatment efficiency,

and the high score was associated with high

treatment efficacy (10,11). In addition, pain

intensity was measured on a validated 11-

point numeric box scale (NBS) from 0 to –10,

with ‘0’ as no pain and ‘10’ as the worst

imaginable pain. A low pain intensity score

was regarded a preferred score (10,11). Pain at

dressing change was rated (NBS) by the

patients at the visits on days 2 and 5 and on

days 45 and 47, immediately after removal of

the dressing and cleansing of the wound.

Patients were asked to score their pain

intensity on the 0–10 NBS.

The ulcer area was assessed at baseline, on

days 15, 29 and on day 42 with wound tracings

of the ulcer margins. Infection was assessed by

coexistence of the classical signs of clinical

infection: pain, erythema, oedema, heat and

purulence. Delayed or stalled wound healing

and one of the following three characteristics

identified bacterial imbalance: increased level

of exudate, granulation tissue, discoloration or

odour; the combination led to study exclusion.

Safety was monitored according to the Euro-

pean standards for testing medical devices on

human subjects (12,13). The causality of the

adverse event was defined as related, possibly

related and not related to the dressing. All

adverse events in this study were reported

spontaneously either by the patients or by the

study personnel.

MaterialsThe two moist wound-healing foam dressings

used in this study absorb exudate and provide

a physical barrier between the wounds and the

environment. The ibuprofen-foam (Biatain-Ibu

non adhesive foam dressing, Coloplast A/S)

consists of a soft hydrophilic polyurethane

foam containing ibuprofen (ibuprofen concen-

tration: 0�5 mg/cm2) homogeneously dis-

persed throughout the foam. The foam is

bound to a semipermeable polyurethane film.

In the presence of exudate, there is a continu-

ous release of a safe low-dose ibuprofen into

the wound bed (14). One dressing (15 � 15 cm)

Key Points

• all adverse events in this study

were reported spontaneously

either by the patients or by

the study personnel

• the two moist wound healing

foam dressings used in this

study absorb exudate and pro-

vide a physical barrier between

the wounds and the environ-

ment.

• the ibuprofen foam is bound to

a semi-permeable polyurethane

film and in the presence of

exudate, there is a continuous

release of a safe low dose of

ibuprofen into the wound bed

Double-blind comparison with a pain relieving dressing

26 ª 2007 The Authors. Journal Compilation ª 2007 Blackwell Publishing Ltd and Medicalhelplines.com Inc

contains 112�5 mg of ibuprofen to be released

between 1 and 7 days, compared to a maximum

daily oral dose of 1200 mg and in special cases

3200 mg (15). A proof of concept study

suggested an anti-inflammatory and pain-

reducing effect of the dressing (16). The

comparator foam consisted of the same mate-

rials and had a similar structure as the

ibuprofen-foam, but ibuprofen was not incor-

porated (Biatain non adhesive, Coloplast A/S).

The backing film and the packaging of the two

compared dressings were similar to ensure the

double blinding.

Clinical endpointsThe ibuprofen-foam was regarded as a thera-

peutically effective treatment if the pain relief

was significantly higher and pain intensity

ratings were significantly lower compared

with the comparator product during days

1–5. The primary endpoint was persistent pain

relief during the first 5 days. Secondary

endpoints were reduction in persistent pain

intensity on days 1–5, ulcer area reduction,

difference between groups in adverse events

and pain intensity on days 43–47. Other

secondary endpoints were temporary pain at

dressing change, occurrence of critical coloni-

sation, and selected activities of daily living

indicators such as well-being, appetite, sleep

and mood.

Data analysis and statisticsSample size was determined by evaluating

a previous study (16) on pain relief observed

on a 5-point scale during morning and evening

where an overall mean pain relief of 3�8 for the

ibuprofen-foam and 3�3 for the comparator

was observed. The common standard devia-

tion was 0�79. With a 90% power, this yields

a sample size of 54 per group (data on file).

Empirically a drop-out rate of 10% is observed

in similar clinical studies, hence resulting in

a sample size of 60 per group. Before the

statistical analysis was performed, the data

were entered twice and discrepancies resolved.

All data analysis was performed on the

intention-to-treat (ITT) population. The pri-

mary response variable was persistent pain

relief on days 1–5. The secondary outcome

variables were persistent pain intensity, ulcer

size, pain at dressing change, activities of daily

living and adverse events. The results were

analysed according to the statistical analysis

plan designed prior to study commencement

(17). Alpha was set at 0�05. The persistent pain

relief for days 1–5 was for each patient

assessed during morning and evening on a 5-

point VRS (none, slight, moderate, lots, com-

pletely). After dichotomising data (relief, no

relief), differences were analysed with an anal-

ysis of variance. Persistent pain intensity for

each patient was assessed during morning and

evening on an 11-point NBS and analysed with

an analysis of variance, and statistically signif-

icant (P , 0�05) parameters were reported

together with adjusted treatment means. Pain

at dressing change (temporary pain) was

evaluated after each dressing change between

day 1–5 and days 43–47. An analysis of vari-

ance was used to test differences between

groups. For the follow-up period, the visit on

day 43 was used as the baseline for the dress-

ing pain intensity. Adverse events were divided

into the following categories: non device–

related adverse events, non device–related

serious adverse effects, device-related adverse

events and serious device-related adverse effects.

Any difference in observed adverse events

between study groups was tested using a chi-

square test.

Ulcer size was recorded at inclusion and

after 15, 28 and 42 days of treatment. A t-test

was used to test differences in means reported

for the ITT population. Wound healing was

also tested using a linear healing parameter, as

described by Gilman (18). This quantifies

wound healing as the linear movement of the

wound edge towards the centre of the wound.

RESULTS

Baseline dataThe study population consisted of 122 patients

(62 in the ibuprofen-foam group and 60 in the

comparator group) with chronic, painful

venous leg ulcers on the lower limb. Patients

were recruited from 13 different centres: three

in Great Britain, three in Lithuania, two in

Denmark, two in Germany, two in the Czech

Republic and one in Finland. The first patient

was included on 19 September 2005, and last

patient out was on 21 April 2006, with a clinical

report approved by investigators on July 2006.

Table 1 summarises the demographic profile

of the study group. Table 2 summarises the

medical history of the patients. In the ibupro-

fen-foam group, 11% (7/62) of the patients

Key Points

• the comparator foam consisted

of the same materials and had

a similar structure but ibupro-

fen was not incorporated

• the study population consisted

of 122 patients (62 in the

ibuprofen foam group and 60

in the comparator group) with

chronic, painful venous leg

ulcers on the lower limb

• all patients were asked to keep

their concomitant medication

constant between days 1-5

and days 43-4

Double-blind comparison with a pain relieving dressing

ª 2007 The Authors. Journal Compilation ª 2007 Blackwell Publishing Ltd and Medicalhelplines.com Inc 27

dropped out of the study prematurely, and 5%

(3/60) did not complete the study in in the

comparator group. The dropouts were related

to withdrawal of consent (4), protocol violation

(3), pain in the study ulcer (1), serious non

related adverse event (1) and suspected allergic

reaction (1). In this trial, all patients were asked

to keep their concomitant medication constant

between days 1–5 and days 43–47, and no

patient was excluded due to change in pain

medication.

Pain

Persistent pain relief on days 1–5In the ibuprofen-foam group, patients experi-

enced significantly (P ¼ 0.0003) more pain

relief in the wound throughout the first 1–5

days of wear time compared with the compar-

ator. In the first evening, 74% (46/62) of the

patients in ibuprofen-foam group had pain

relief, compared with 58% (35/60) in the

comparator group (Figure 2). Twenty-eight

percent (74 - 58/58 � 100) more patients

experienced pain relief the first evening in the

ibuprofen-foam group than in the comparator.

Persistent pain intensity on days 1–5Wound pain was significantly reduced with

the ibuprofen–foam during days 1–5 (P ,

0�0003). The wound pain intensity levels were

reduced from 6�8 at inclusion to 4�1, a reduction

of 40% with the ibuprofen-foam, and from 6�6

at inclusion to 4�6, a reduction of 30% with the

comparator. Women reported less pain inten-

sity than men, and pain intensity decreased

with increasing age. Furthermore, pain inten-

sity increased with increasing baseline pain

intensity and increasing wound size (Table 3).

Pain at dressing changeDressing change–related pain intensity

increased in the former ibuprofen-foam group

when the non adhesive comparator was in-

troduced between days 43 and 47. A signifi-

cant difference (P , 0�05) in pain intensity was

detected at dressing removal (Figure 3). The

pain intensity increased significantly for the

previous ibuprofen-foam group from baseline

NBS value of 0�3 to 0�9 (0�9/0�3 � 100 ¼ 300%)

in contrast to constant levels in the comparator

group with an average NBS value of 2�0 at

baseline. At days 1–5, it was not possible to

detect a difference in dressing change pain.

Ulcer areaThe ulcers decreased on average from 11�2

to 7�9 cm2 in the ibuprofen-foam group and

from 7�2 to 3�8 cm2 in the comparator group

(Figure 4). The decrease in ulcer area between

Table 1 Demographics of patients in the two treatment groups

Assessment Ibuprofen-foam Comparator

Age (years) Mean 66�0 70�0

Standard deviation 14�8 11�7

Gender Female, n (%) 43 (69) 37 (62)

Height (cm) Mean 168 168

Standard deviation 1�3 1�2

Weight (kg) Mean 83�0 79�4

Standard deviation 2�6 2�1

Table 2 Important baseline values of patients in the two treatment groups

Assessment Ibuprofen-foam Comparator P value

Pain intensity at inclusion

(numeric box scale)

Mean 6�82 6�58 NS

Standard deviation 1�8 1�6

Exudate level of ulcer Moderate, n (%) 41 (66) 51 (85) —

High, n (%) 21 (34) 9 (15)

Absolute ulcer area (cm2) Mean 11�0 7�3 ,0�05

Standard deviation 9�6 5�7

Absolute ulcer circumference (cm2) Mean 15�5 12�5 NS

Standard deviation 9�1 6�9

—, not tested; NS, not significant.

Key Points

• wound pain was significantly

reduced with the ibuprofen

foam during days 1-5

• dressing change related pain in-

tensity increased in the ibuprofin-

foam group when the non

adhesive comparator was intro-

duced between days 43-47

• the decrease in ulcer area

between the 2 groups was

comparable with no statistical

difference in healing time

Double-blind comparison with a pain relieving dressing

28 ª 2007 The Authors. Journal Compilation ª 2007 Blackwell Publishing Ltd and Medicalhelplines.com Inc

the two groups was comparable, with no

statistical difference. The wound area decrease

between inclusion to day 43 divided by the

average wound circumference was not signif-

icantly different between the groups using the

Gilman (18) method. Both study group wound

perimeters moved towards the centre of the

wounds with comparable speed. Ten ulcers in

the comparator group and nine ulcers in the

ibuprofen-foam group healed during the trial,

and there was no statistical difference in

healing time.

Adverse eventsIn total, 31 adverse events on 19 persons were

reported (Table 4). In the ibuprofen-foam

group, 12 patients experienced 21 adverse

events, and in the comparator group, seven

patients experienced ten adverse events. One

patient was hospitalised (serious adverse event)

because of a non device–related pulmonary

oedema and was excluded from the study.

In the ibuprofen-foam group, 19% (12/62)

adverse events were reported compared with

12% in the comparator group (7/60). The

relation to the device is reported in Table 4.

Most of these adverse events had no relation to

either the ulcer or the dressing. There were no

serious device-related adverse events reported

in the study. The device-related adverse events

were categorised into four groups: study ulcer

pain, infection in study ulcer, local skin

reactions and other. Skin reactions were, in

the ibuprofen-foam group, observed with four

patients; one had urticaria and later eczema,

one had eczema alone, and two had blisters. In

the comparator group, four patients had skin

reactions: two had eczema and two had

blisters. In the ibuprofen-foam group, allergic

dermatitis was suspected in one patient. A

Ibuprofen-foam Comparator

Pers

ons w

ith p

ain

relie

f th

e first evenin

g (

%)

10

09

08

07

060

50

Figure 2. Percentage of patients with pain relief the first evening including standard deviations. The first evening there were 28%

more persons with pain relief in the ibuprofen – foam (74%) group, than the comparator group (58%).

Table 3 Patients’ pain intensity depended on the following

statistically significant variables from the analysis of variance

(d.f. ¼ 914) on morning and evening pain intensity values from

day 1 to 5

Effect P value Interpretation

Treatment (ibuprofen-

foam versus

comparator alone)

0�0003 Ibuprofen-foam

reduces pain

intensity

Time (between

assessments)

,0�0001 Pain intensity

for all patients

decreases over time

Gender (women) 0�01 Women have

less pain

Age ,0�0001 Older people

have less pain

Baseline pain

intensity

,0�0001 High baseline pain

level, associated

with high levels

of pain at any time

or with any treatment

or other included

variables

Baseline ulcer size ,0�0001 Larger ulcers,

associated with

higher pain levels

Key Points

• in the ibuprofen-foam group12

patients experienced 21 adverse

events

• in the comparator group 7

patients experienced 10 adverse

events

• most of these adverse events

had no relation to either the

ulcer or the dressing

Double-blind comparison with a pain relieving dressing

ª 2007 The Authors. Journal Compilation ª 2007 Blackwell Publishing Ltd and Medicalhelplines.com Inc 29

patch test was applied on the patient’s normal

skin. The patch test showed a weak, poten-

tially allergic reaction to the complete product,

but not to ibuprofen-standardised patch test

(petrolatum base), or to the comparator prod-

uct. The negative patch tests to the compo-

nents of the dressing controverts a contact

irritant dermatitis, although there is a slight

chance that the patient is allergic to a metabo-

lite of ibuprofen.

DISCUSSIONThis study has confirmed the benefit of foam

dressing with low-dose ibuprofen for the

treatment of persistent chronic wound pain.

In proof-of-concept studies, Jørgensen et al.

(16), Sibbald et al. (19) and Flanagan et al. (5)

have demonstrated that the ibuprofen–foam

combines effective moist wound healing and

ibuprofen release. This combined action re-

duced persistent pain, reduced pain at dress-

ing change and increased quality of life,

without being able to detect ibuprofen in the

blood plasma (16). This randomised, con-

trolled, double-blind study was designed for

a 42-day treatment period plus an additional

follow-up period of 5 days, where all patients

were treated with the comparator foam dress-

ing alone without ibuprofen. Based on results

from preclinical and human pilot studies

(5,16,19,20), a treatment period of 42 days

should be sufficient time for evaluating

adverse events and following the change in

wound healing (e.g. ulcer area). Biatain Non

adhesive foam dressing was considered the

appropriate comparator product, as the pres-

ence of ibuprofen was the only difference

between the two dressings. The addition of

the follow-up period days 43–47 was to test

whether patients from the ibuprofen-foam

group would experience increase in pain

during the last 5 days due to the withdrawal

of the local low-dose release of ibuprofen.

Patient populationThe patients in previous studies that compared

the analgesic effect of topical ibuprofen on

Days

43 45 47

Pain

at dre

ssin

g c

hange / (

NB

S)

32

10

Ibuprofen-foam

Comparator

Figure 3. Pain at dressing change on days 43–47 increased in the former ibuprofen–foam group (P ¼ 0�05). NBS, numeric box

scale.

14

12

10

86

42

0

Days

Ulc

er

are

a /

cm

2

1 15 29 42

Ibuprofen-foamComparator

Figure 4. Absolute change in ulcer area (cm2) on the

intention-to-treat population. There was no statistical signifi-

cant difference on ulcer area reduction (P ¼ 0�26) between the

treatment groups.

Key Points

• this study confirmed the benefit

of foam dressing with low-dose

ibuprofen for the treatment of

chronic wound pain

Double-blind comparison with a pain relieving dressing

30 ª 2007 The Authors. Journal Compilation ª 2007 Blackwell Publishing Ltd and Medicalhelplines.com Inc

intact skin with systemic use of ibuprofen were

rarely above 50 years of age (21–23). In the

ibuprofen-foam group of this study, the

patients were on average 66 years of age, and

70 years of age in the comparator group

(Table 1). The ideal patient in a pain trial

may be often younger and male because pain-

relieving medication is more likely to result

in improved pain scores (24). For this reason,

there are few previous reports of topical pain

trials in an older, often female-predominant

polymedicated population. Therefore, this inves-

tigation, together with the few clinical trials

on interventions on the elderly population,

showing statistical differences has high societal

value.

PainPatients’ perception of pain is known to

change over time (11). Therefore, to get com-

parable results, pain interventions must be

evaluated over relatively short periods (10).

Persistent pain relief on days 1–5The primary endpoint of this study was pain

relief. This study demonstrated that patients

treated with the ibuprofen-foam had more

pain relief than the comparator group (P ,

0�05). This significant result is in line with

a pilot cross-over study that demonstrated a

reduction in pain intensity when changing

from a comparator to the ibuprofen-foam (16).

More patients (28%) in the ibuprofen-foam

group had pain relief in the first evening

(Figure 2), indicating that the observed pain

relief has a quick onset of action. In a meta-

analysis of topical non steroidal anti-inflamma-

tory drug gels by Mason et al. (25), comparable

results were shown, where the active treatment

had an effect on 48% of patients, compared

with 26% from placebo. In this case, we

observed pain relief in 74% of patients in the

active group compared with 58% in the

comparator group. Ibuprofen is mainly re-

ported to have an effect on pain that is of

a nociceptive origin (22). Therefore, it is not

expected that the ibuprofen-foam would be

effective in all patients. There is evidence in the

literature (26) that moist wound healing

provides pain relief. This study shows that by

adding ibuprofen to a moist wound healing

foam, an even stronger pain relieving effect is

experienced by patients.

Persistent pain intensity on days 1–5In this study, the data demonstrated that the

pain intensity levels were reduced with the

ibuprofen-foam, 40% from baseline compared

with a 30% reduction for the comparator.

Farrar et al. (27) found in a meta-analysis of

pain trials, where the 11-point NBS scale was

used, that a 30% reduction in pain intensity

was clinically relevant. This means that both

the ibuprofen-foam and the comparator prod-

uct had clinically relevant pain reductions,

with the ibuprofen-foam having a slight ad-

vantage. The pain intensity levels were also

influenced by gender, age, initial pain level,

and wound size.

Pain at dressing changePain at dressing change or removal has been

identified as a key patient concern (28,29). The

ibuprofen-foam seemed to be associated with

decreased pain at dressing change. On days

43–47, the former ibuprofen-foam group expe-

rienced an increment in their dressing-change

pain. This increase was interpreted as a

response to the removal of the analgesic effect.

In other studies by Jørgensen et al. (16) and

Sibbald et al. (19) similar results were observed,

where the ibuprofen-foam reduced pain at

dressing change. Pain at dressing change was

not significantly different between the two

comparative groups on days 1–5. Pain percep-

tion can be influenced by the effect of care (30);

Table 4 Adverse events separated into mild, moderate and severe and relation to device for the ibuprofen-foam and the

comparator group

Type of adverse event

Ibuprofen-foam* Comparator†

P valueUnrelated Possible related Related Total Unrelated Possible related Related Total

Total N (%) 3 (14) 5 (24) 13 (62) 21 (100) 1 (10) 3 (30) 6 (60) 10 (100) NS‡

*Infection in study ulcer, three patients; eczema, two patients; blisters, two patients; urticaria, one patient; study ulcer pain, one

patient; other, 12 patients (13 incidences unrelated to the dressing).†Infection in study ulcer, two patients; bullae, one patient;

eczema, two patients; blisters, one patient; other, four patients (six incidences unrelated to the dressing).‡NS, not significant.

Key Points

• more patients in the ibuprofen-

foam group had pain relief in

the first evening indicating the

quick onset of relief from the

ibuprofen-foam

Double-blind comparison with a pain relieving dressing

ª 2007 The Authors. Journal Compilation ª 2007 Blackwell Publishing Ltd and Medicalhelplines.com Inc 31

thus, measuring pain when crossing all pa-

tients over to the comparator foam is inter-

preted as a new baseline for the moist wound-

healing parameters of the foam dressing alone.

On day 43, the patients were accustomed to the

best standard care. Therefore, differences

observed during days 43–47 could be inter-

preted as free of the effect of care. Indirectly, it

was, therefore, shown that the patients in the

former ibuprofen-foam group versus the com-

parator had experienced less pain at dressing

change.

Ulcer areaThe ibuprofen-foam dressing was regarded as

successful if the healing properties were

similar to or better than those of the compar-

ator foam. In this study, the patients in the

ibuprofen-foam study had larger ulcers at

baseline compared with the comparator group

(P , 0�05). Area-based comparisons of the

ulcer, therefore, gave biased results (18). In

such case, a comparison of the linear healing

parameter is more appropriate as it would not

be affected by the difference in baseline wound

area. Using this method (as well as mean area),

no difference in wound healing between the

ibuprofen-foam and the comparator group

was found.

Ibuprofen has an anti-inflammatory effect,

and some literature discusses the effect of

ibuprofen on wound healing (31–34). Theoret-

ically, ibuprofen could inhibit the normal

inflammatory wound-healing stage by reduc-

ing the amounts of prostaglandin. Most of the

reported research has been performed on acute

wounds, or with extremely high doses of

ibuprofen in preclinical studies on animals,

with variable outcomes (35). Often, patients

with a chronic wound suffers from chronic

medical disorders and the wounds may be

stuck in the inflammatory phase (36). There-

fore, low-dose ibuprofen use in chronic

wounds is less likely to significantly influence

healing of chronic wounds (16). Both methods

used in this study to quantify wound healing

showed that there was no difference in the

chronic wound–healing rate between compar-

ative groups, and the healing rate was compa-

rable with earlier randomised controlled trials

on the comparator foam (37).

Healing venous leg ulcers requires compres-

sion bandaging (6). In this study, patients were

required to receive compression bandaging

before inclusion and throughout the study

period. However, patients often discontinue

compression treatment because of the associ-

ated pain. In a study by Briggs and Closs (6) on

96 venous leg ulcer patients, 44% of patients

could not adhere to their compression ther-

apy because of persistent wound pain. Conse-

quently, for chronic ulcer patients, pain is a

serious barrier to wound healing. An ibuprofen–

foam may be a good solution for increasing

patient’s compression bandage adherence.

In addition, for the 30% of patients who are

unlikely to heal within 5 years (38), pain

control should be considered as important to

patients as healing.

Adverse eventsThe usual adverse events reported for ibupro-

fen are related to relatively high dose with oral

intake (15). None of the most frequently

reported oral ibuprofen adverse events (15)

were observed in this study. The 15 � 15 cm

ibuprofen-foam chosen in this investigation

contains 112�5 mg of ibuprofen to be released

into the wound over 7 days, depending on the

exudate level (14). This is much lower than the

recommended daily dose of 1200 mg, and in

special cases 3200 mg (39). It has been shown

in another study that the ibuprofen could not

be detected systemically when the ibuprofen-

foam was used (16).

The data from this study and other clinical

studies on the ibuprofen-foam including

more than 373 patients (5,15,19,20,39) have

not detected any cases of allergic or contact

dermatitis as adverse reactions to the ibupro-

fen-foam. A meta-analysis on topical use of

ibuprofen including studies from 1500 patients

has demonstrated no difference in adverse

reactions (including allergies) between placebo

and topical use of ibuprofen gels (25). Based on

the results from this study and the literature,

the likelihood of adverse events with the

ibuprofen-foam would be considered low. The

likelihood of adverse events following long-

term use of the ibuprofen-foam is unknown.

CONCLUSIONThis is a report of a multinational and multi-

centre, randomised, double-blind, clinical

investigation on ibuprofen-foam. The study

compared two moist wound-healing dressings

and included 122 patients, with 62 random-

ised to the ibuprofen-foam and 60 to the

Key Points

• the ibuprofen-foam showed

clinically relevant pain reduc-

tions in the intensity of the

wound

• the pain intensity levels were

also influenced by gender, age,

initial pain level and wound size

Double-blind comparison with a pain relieving dressing

32 ª 2007 The Authors. Journal Compilation ª 2007 Blackwell Publishing Ltd and Medicalhelplines.com Inc

comparator. The primary outcome, the persis-

tent wound pain relief during the first 1–5

days, was significantly higher in the ibuprofen-

foam group. There was a quick onset of action,

with a significant pain relief in the first

evening. Women reported less pain intensity

than men, and pain intensity decreased with

increasing age. In addition, pain intensity

increased with increasing initial pain intensity

and increasing wound size. Wound healing

was similar in the ibuprofen-foam group to

that of the group that used comparator foam

alone. No difference in adverse events between

comparator and local sustained release of low-

dose ibuprofen was observed in this study.

There was no difference between dressing

absorption capacity between the two com-

pared dressings. This study has demonstrated

that the ibuprofen-foam dressing is beneficial

for persistent pain relief and reducing persis-

tent and temporary wound pain intensity

without compromising healing or safety.

ACKNOWLEDGEMENTSThis study was supported by Coloplast A/S,

Holtedam 1, 3050 Humlebæk, Denmark, and

its affiliates. Our appreciations to Clifo A/S for

handling patient monitoring, double data

entry and cleaning and statistical data analysis.

Thanks to Rikke Holt Agerslev, Søren Nymand

Lophaven and Ole K. Nielsen for their contri-

butions to writing the manuscript.

CONFLICTS OF INTERESTR. R. has acted as a paid researcher for

Coloplast and received funding for that

research. V. V. received funding for the salary

of the research nurse involved in this work.

P. V. and K. E. received renumeration for the

extra time involved in study participation

according to international guidelines.

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> : ? = 6 9 A 9 9 : 5 9 8 5 8 ; < : ; = 6 = > : ? > : 5 8 = 9 @ A = B C D{ S K L N R S K I Q I K R I I K R X L J S L I ` S K R V N V S Q s X I U N J Q R I Q K J L N L L I U L S U S V L J K ` J Q X t W M S Q U NI K P X ` N g J b X P V S Y I Q S _ X Q x q � L I K L I U N U ^ Q I N b N K I Y V I Q R I N X Q y q � L I V I L X M M J W Q L I U ] V X P SL I U M S ` P N V N L S V Z Ê N V V N V � � � r Z h d z p I Q M S Q R V N V S Q _ I Q X Q ` I R N N Q | U J K J K L I I Q K N t S K K S b V IL S U S V L S Q L I K I I ` P U I W U N I K M N U N Q X ` a V J M N L I c c P X Q R S K _ s X I X Q N V I L X M M J W Q L I X Q y q �I V N M U ^ Q J M N ` I Q R I V I U I \ N Q R I Z � K R S K J ] Q J Y J M N s X I R N Q R S U N I K P X ` N g J b X P V S Y I Q S M S ` S I UP V S L X M R S M S ` P N V N L S V R X \ J I V S Q V I L X M M J S Q I K L I L S U S V M U ^ Q J M N ` I Q R I V I U I \ N Q R I K _ R I Q J I Q L S U N

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I Q S I K b N v N Z { N P V S b N b J U J L N L L I I Y I M R S K N L \ I V K S K R V N K I U X K S NU N V ] S P U N O S L I I U N P W K J R S L I I K P X ` N g J b X P V S Y I Q S I K L I K M S Q S M J L N Z¼ º G ¼ Â E D ¸ ½ G� K R I I K X Q J Q Y S V ` I K S b V I X Q I K R X L J S M U ^ Q J M S ` X U R J Q N M J S Q N U _ ` X U R J M a Q R V J M S _ V N Q L S ` J O N L S _L S b U I M J I ] S K S b V I X Q N P W K J R S L I I K P X ` N g J b X P V S Y I Q S Z � U I K R X L J S M S ` P N V W L S K N P W K J R S KP N V N U N M J M N R V J O N M J W Q L I X U M I V N K I Q N ` b J I Q R I e T ` I L S I J Q M U X t S N c d d P N M J I Q R I K _ M S Q i dV N Q L S ` J O N L S K e N M J N I U ] V X P S L I I K P X ` N g J b X P V S Y I Q S t i q e N M J N I U ] V X P S L I UM S ` P N V N L S V Z � U P V J Q M J P N U V I K X U R N L S L I U I K R X L J S Y X I s X I I U N U J \ J S L I U L S U S V P I V K J K R I Q R IN K S M J N L S N U N T U M I V N I Q U S K L ^ N K c k w _ Y X I K J ] Q J Y J M N R J \ N ` I Q R I ` N t S V I Q I U ] V X P S L I U NI K P X ` N g J b X P V S Y I Q S Z � X b S X Q V | P J L S I K R N b U I M J ` J I Q R S L I U I Y I M R S N Q N U ] a K J M S _ M S Q X QN U J \ J S K J ] Q J Y J M N R J \ S L I U L S U S V I Q U N P V J ` I V N Q S M e I Z { N K ` X v I V I K V I Y J V J I V S Q ` I Q S VJ Q R I Q K J L N L L I L S U S V s X I U S K e S ` b V I K _ t U N J Q R I Q K J L N L L I U L S U S V L J K ` J Q X t W M S Q U N I L N L Zn L I ` | K _ U N J Q R I Q K J L N L L I U L S U S V I V N ` N t S V M X N Q R S ` N t S V I V N I U L S U S V J Q J M J N U t M X N Q R S` N t S V I U R N ` N � S L I U N T U M I V N Z � U ] V N L S L I M J M N R V J O N M J W Q L I U N K T U M I V N K Y X I K J ` J U N V I Q I U] V X P S L I I K P X ` N g J b X P V S Y I Q S t I Q I U ] V X P S L I U N P W K J R S L I I K P X ` N K S U N Z � Q I K R I I K R X L J SQ S K I S b K I V \ N V S Q L J Y I V I Q M J N K I Q U S K I Y I M R S K N L \ I V K S K I Q R V 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