Randomized trial of two foam dressings in the management of chronic venous ulceration

Abstract

A multicenter prospective randomized clinical trial was undertaken to compare two foam dressings (Allevyn Hydrocellular, Smith & Nephew and Mepilex, Molnlycke Health Care AB) in the management of chronic venous leg ulceration. Patients were also randomized to two compression bandage systems (4-layer vs. cohesive short stretch) as a factorial design. Those with causes of ulceration other than venous disease were excluded. In all, 156 patients met the entry criteria and were randomized from the 12 clinical centers with a median (range) ulcer size of 4.33 (0.33-123.10) cm(2). After 24 weeks a total of 100 (64.1%) patients had complete ulcer closure, 46 (29.5%) had withdrawn from the trial, nine (5.8%) remained unhealed and one patient died. Of the patients randomized to Mepilex, 50/75 (66.7%) had complete ulcer healing compared with 50/81 (61.7%) on Allevyn. The hazard ratio for healing after adjustment for bandage type and trial center was 1.48 (95% C.I. 0.87-2.54, p=0.15), which only marginally changed following adjustment for baseline variables, neither of which achieved statistical significance (p=0.16). Withdrawal rates were similar between groups (23, 30.7% Mepilex vs. 23, 28.4% Allevyn). Pain improved following treatment with both dressings (p<0.001), but with no difference between dressings.

Efeitos biológicos da luz: aplicação de terapia de baixa potência empregando LEDs (Light Emitting Diode) na cicatrização da úlcera venosa: relato de caso

“…Mesmo assim, este importante sintoma é negligenciado durante o tratamento da mesma (BARRON; JACOB; KIRSNER, 2007). Alguns métodos que, além de facilitar a cicatrização, possam promover analgesia estão sendo aplicados como os curativos com géis, as faixas de compressão elástica (FRANKS et al, 2007;JORGENSEN;FRIIS;GOTTRUP, 2006) e, dentre outros, o laser de baixa potencia que ainda necessita de maiores estudos para comprovar sua eficácia no tratamento da dor em pacientes com úlcera venosa (LAGAN et al, 2002); assim como, o mesmo já comprovou seus efeitos no tratamento de outras algias (JENSEN; HARMS-RINGDAHL, 2007; LAM; CHEING, 2007;STERGIOULAS, 2008). Lagan et al (2002), utilizando laser de baixa potência e fototerapia, relata possível melhora da dor, após doze semanas de tratamento, diferentemente deste estudo, no qual a dor chega a zero na segunda sessão e oscila até a 18ª sessão estabilizando em um patamar inferior ao da úlcera controle; o que também foi encontrado por Lagan et al (2000) em um estudo de caso sobre o laser em úlceras venosas.…”

A Randomized Crossover Investigation of Pain at Dressing Change Comparing 2 Foam Dressings

“…The SF-MPQ was also used to measure pain in a study comparing 2 foam dressings. 38 A total of 159 patients with venous leg ulcers rated pain according to the SF-MPQ at baseline and the end of 4 weeks. The pain ratings were significantly lower at week 4 than baseline for both dressings before and after dressing changes (P < .001).…”

Comparative effectiveness of advanced wound dressings for patients with chronic venous leg ulcers: A systematic review

“…We included 37 studies (38 publications) enrolling a total of 3,990 patients (Figure ) . Thirty‐six of 37 studies were RCTs, one was a nonrandomized trial, and another was a retrospective cohort study.…”

“…Trials that met our criteria compared wound infection rates of hydrocolloid dressings with compression or with an antiseptic/antimicrobial plus compression; foam dressings with and without ibuprofen; acellular and cellular human skin equivalents with compression; an antimicrobial dressing with paraffin gauze plus compression; and spray cell therapy with a foam dressing and found no differences in infection rates across intervention arms . Contact dermatitis was reported in two studies, which found no difference . No study evaluated maceration.…”