R. Gary Sibbald

Reducing wound pain in venous leg ulcers with Biatain Ibu : A randomized, controlled double-blind clinical investigation on the performance and safety

Six out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicenter randomized double‐blind clinical investigation of 122 patients compared two moist wound healing dressings: a nonadhesive foam dressing with ibuprofen (62 patients randomized to Biatain Ibu Nonadhesive Coloplast A/S) and a nonadhesive foam without ibuprofen (60 patients to Biatain Non‐Adhesive—comparator). Patients were recruited from September 2005 to April 2006. The ibuprofen foam was considered successful if the pain relief on a five‐point Verbal Rating Scale was higher than the comparator without compromising safety including appropriate healing rate. Additional endpoints were change in persistent wound pain between dressing changes and pain at dressing change on days 1–5 (double blind) and days 43–47 (single blind). The primary response variable, persistent pain relief, was significantly higher in the ibuprofen‐foam group, as compared with the comparator on day 1–5, with a quick onset of action (p<0.05). Wound pain intensity was significantly reduced with the ibuprofen foam during day 1–5 with 40% from baseline, compared with 30% with the comparator (p<0.001). At day 43–47, the patients in the ibuprofen‐foam group had a significant (p<0.05) reemergence of persistent pain and pain at dressing change (p<0.05) when the active dressing was changed to the comparator. Wound healing was similar in the ibuprofen foam and comparator group. No difference in adverse events between the comparator and the ibuprofen foam with local sustained release of low‐dose ibuprofen was observed in this study. It was generally found that women reported less pain intensity than men, and pain intensity decreased with increasing age. In addition, pain intensity increased with initial pain intensity and increasing wound size. This study has demonstrated that the ibuprofen‐foam dressing provided pain relief and reduced pain intensity without compromising healing or other safety parameters.

Contact Allergens in Persons With Leg Ulcers: A Canadian Study in Contact Sensitization:

Individuals with chronic leg ulcers often develop contact allergic reactions to topical preparations used to treat their wounds and the surrounding skin. The objective of this study was to determine the frequency of positive patch test responses to common allergens in patients with leg ulcers or venous disease. A case series of 100 consecutive, consenting patients with chronic venous disease and other causes of leg ulcers that were available for patch testing were enrolled. The patients were tested with 38 common allergens, including those most relevant to leg ulcers. A total of 46% of the patients had at least 1 positive patch test response. Multiple reactions in the same patient were common. The most frequent groups of sensitizers were fragrances, lanolin, antibacterial agents, and rubber-related allergens. Though the prevalence of positive patch test reactions is high in this population, it is lower than commonly reported. This may be the result of clinical practice that considered the avoidance of common sensitizers in the management of patients with leg ulcers.

Vacuum-assisted closure home care training: a process to link education to improved patient outcomes

Negative pressure wound therapy (NPWT) applies subatmospheric pressure across the wound bed inducing cellular and molecular changes that are beneficial to wound healing. This healing modality may facilitate tissue debridement, infection/inflammation control, and moisture balance; the key components of the wound bed preparation paradigm. To ensure that scientific evidence is diffused into daily clinical practice, we are proposing a knowledge transfer model that articulates an educational plan for the various levels of professional development. The discussion highlights the challenges and potential solutions to integrate NPWT into a seamless continuum of care including a community‐based patient care model.

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

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.

Less pain with Biatain-Ibu: initial findings from a randomised, controlled, double-blind clinical investigation on painful venous leg ulcers

Six 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 regarded successful, if the pain relief on a 5‐point verbal rating scale was higher than the comparator without compromising safety, including appropriate healing rate. Additional endpoints were change in persistent wound pain between dressing changes and pain at dressing change on days 1–5 and days 43–47. The primary response variable, persistent pain relief, was significantly higher in the ibuprofen‐foam group compared with the comparator on days 1–5, with a quick onset of action (P < 0·05). The patients in the ibuprofen‐foam group had a significant (P < 0·05) higher reduction in the persistent wound pain from baseline (40%) as the comparator (30%). 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 comparator group. No difference in adverse events between placebo and local sustained release of low‐dose ibuprofen was observed in this study. This study has demonstrated that the ibuprofen‐foam dressing provided pain relief and reduced pain intensity without compromising healing or other safety parameters. The full report of this study will be published in Wound Repair and Regeneration.

Wound bed preparation and oxygen balance – a new component?

Chronic wounds have traditionally been treated by conservative means. It was Winter’s moist wound healing research, in 1962, that stimulated a proliferation of a moist interactive dressing technologies. Even considering this advancement in thinking, chronic wounds continue to be a problem for many clinicians. An increasing delineation of the science of healing in the past 20u2003years has redefined the way in which we both evaluate and treat wounds. This scientific understanding has raised wound care from the clinical problem arena to that of clinical specialty, where many now cross refer patients to specialists in this field. Wound bed preparation (WBP) has played a significant role in this change in practice. The concept has changed an ‘art’ of switching at random from one dressing to another, into a clinical science. WBP has come to the forefront as a major educational aid to help others develop appropriate treatment of the underlying disease causing the wound and patient requirements. The concept of WBP evolved over the recent years, becoming more and more sophisticated with time. Recent adaptations have brought together many of the current components. This article proposes yet another element of WBP, that of ‘oxygen balance’.

A lesson in treating the whole patient: Todd Nicholson’s story

The authors present a patients story to demonstrate the usefulness of a complete patient approach, incorporating V.A.C. therapy, to achieving clinical success from the patients perspective. The article discusses why a total patient approach is important and therapeutic flexibility increases the chance of a successful outcome for all involved.

Palliative Wound Care and Treatment at End of Life

The principles of palliative wound and pressure ulcer care should be integrated along the continuum of wound care to address the whole person care needs of older people who often present with chronic debilitating diseases, advanced diseases associated with major organ failure (renal, hepatic, pulmonary or cardiac), profound dementia, complex psychosocial issues, diminished self-care abilities, and challenging wound-related symptoms. This chapter will introduce key concepts for palliative wound and pressure ulcer care that have been developed by the International Interprofessional Wound Care Community and will review the consensus document entitled SCALE: Skin Changes At Life’s End.