Ibuprofen foam and silver wound contact layer:
A safe combination for treatment of painful,
critically colonised leg ulcers
Jørgensen, B.1, Gottrup, F.1, Karlsmark, T.1, Sibbald, R.G.2,
Bech-Thomsen, N.3

Demographic and baseline measurements
1. Copenhagen. Wound Healing Centre, Bispebjerg University Hospital, Copenhagen, Denmark2. Toronto Wound Healing Centres, University of Toronto, Ontario, Canada3. Skin Clinic, Naestved, Denmark Introduction
Wound pain can be reduced with an ibuprofen releasing foam Initial pain measurement (NBS) (Mean / SD) dressing (Biatain - Ibu, Coloplast A/S)1,2. Furthermore a silver releasing contact layer (Physiotulle - Ag, Coloplast A/S) used Initial ulcer circumference (cm) (Mean / SD) in combination with a secondary absorbent dressing effectively Duration of pain (n / %): Less than 1 month support the wound healing process in critically colonised, exuding venous leg ulcers3. The aim of this study was to investigate the safety and performance of the ibuprofen releasing foam in combination with the silver releasing wound contact layer.
Figure 1 - Persistent pain, diary entries, during
the first five days of the study
The study was an open, non-comparative 30-day study in 4 centres in Denmark and Canada. 24 patients with painful, critically colonised, exuding venous leg ulcers were recruited from outpatient clinics at the participating centres (Table 1).
Pain intensity was assessed by patients twice daily on a 0-10 scale (numeric box scale, NBS). Pain at dressing change was also assessed using the NBS. In addition, wound area and circumference, tissue composition in ulcer bed, odour, exudate handling, ibuprofen Mean (pain) (0-10)
concentration in exudate and adverse events were assessed.
• Persistent pain decreased from NBS 6.3 to 3.0 after 12 hours (1v = 1st visit (inclusion), e = Evening, m = Morning) and pain remained low throughout the study (Figure 1).
• Pain at dressing change rapidly decreased and remained low Figure 2 - Pain at dressing change
• Reduction in relative wound area was 42% after 30 days (Figure 3), (linear healing rate 4,5 = 0.32 cm/4 weeks).
After dressing removalBefore dressing removal • Healthy granulation tissue increased from 32% (mean) of the wound bed to 59% over the study period while unhealthy and sloughy tissue decreased from 15% to 4%.
• Percentage of ulcers with odour decreased from 37% to 8% in Pain (0-10)
9 days, while 4% of the ulcers had odour after 30 days.
• Exudate handling was rated highly throughout the study.
• Within 48 hours ibuprofen concentration in exudate reached a 01 03 05 07 09 11 13 15 17 19 21 23 25 27 29 31
• Of four device-related adverse events, two were patch-tested and evaluated non-allergic (irritant). Two others were maceration Figure 3 - Mean reduction in relative wound area
In conclusion the dressing combination was safe and effective in terms of wound healing and pain reduction. ea (mean %)
The combination of the ibuprofen-releasing foam (Biatain - Ibu) and the silver-releasing wound contact layer (Physiotul e - Ag) demonstrated wound pain reduction and supported healing Relative wound ar
of critical y colonised, exuding painful ulcers.
Days of treatment
1. Gottrup F et al. Int. Wound J. 2007, 4(suppl. 1), 24-34
2. Jørgensen B et al. Wound Repair Regen., 2006, 14(3), 233-239
3. Jørgensen B et al. J Wound Care. 2006, 15(3), 97-100
4. Gilman T. Wounds. 1990, 2(3), 95-101
5. Gilman T. Low Extrem Wounds. 2004, 3(3), 125-132
This work has been made possible by a research grant from Coloplast A/S


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