A pilot (real‐life) randomised clinical evaluation of a pain‐relieving foam dressing: (ibuprofen‐foam versus local best practice)

Abstract

The aim of the study was to evaluate a novel foam dressing with continuous low-level release of ibuprofen (Biatain-Ibu foam dressing, Coloplast A/S, Humlebaek, Denmark) in persons with leg ulcers compared to local best practice. An open comparative and prospective block-randomised study of 24 patients was conducted in a Canadian wound clinic. Twelve patients were randomised to ibuprofen-foam and 12 patients to local best practice. The study population consisted of patients with chronic, painful exudating leg ulcers. The patients rated their wound pain intensity at baseline and after the first dressing application. Pain intensity in the morning and evening was rated during a period of 1 week using a numeric box scale (NBS). A t-test compared the main differences in pain intensity and a five-point verbal rating scale measured the patients' pain relief. At the last clinical visit, pain after dressing change was assessed using an NBS. In addition, wound size, percentage of healthy granulation tissue and the presence of peri-ulcer erythema, were (all) evaluated at inclusion and the end of the study. The nurses and patients both evaluated the relative dressing performance and exudate management at the last study visit. This study demonstrates that the ibuprofen-foam dressing decreased wound pain in patients with leg ulcers compared to best practice. The ibuprofen-foam dressing was associated with: diminished chronic pain between dressing changes, reduced acute pain at dressing change, increased healthy granulation tissue, decreased peri-wound erythema and excellent exudate handling capacity. It can be concluded from the results of the study that the combination of foam with a continuous low-dose release of ibuprofen may offer a valuable new therapeutic approach to the reduction of wound pain.

Wound infection, dressings and pain, is there a relationship in the chronic wound?

“…Clinical trial data support the use of dressings impregnated with an anti‐inflammatory analgesic (Ibruprofen) (Table 18) (50–52). The pragmatic approach taken by this current Delphi panel is not wholly consistent with this and reflects that product innovation do not always readily translate into widespread use.…”

Ibuprofen and hydrogel-released ibuprofen in the reduction of inflammation-induced migration in melanoma cells

“…33,34 We are suggesting that used topically at the time of tumour excision it may also act to reduce melanoma cell migration or invasion at the wound site.…”

The Improvement of Wound-Associated Pain and Healing Trajectory With a Comprehensive Foot and Leg Ulcer Care Model

“…Several randomized controlled trials have indicated that alleviation of woundassociated pain by topical agents improves the subjective evaluation of well-being 32 as well as wound healing outcomes. 33,34 Although an increased number of therapeutic options are available, a comprehensive approach to chronic wound pain remains elusive. The purpose of this study was to evaluate pain control and healing trajectory using a comprehensive care model for foot and leg ulcers.…”