A prospective, randomised controlled crossover study (NCT03662997) comparing three multi-layered silicone foam dressings for the management of chronic wounds finds Mepilex Border Flex (Mölnlycke Health Care, the study’s sponsors) to be statistically superior in terms of wear after one week. Principal investigator Oscar M Alvarez (Rutgers, New Jersey Medical School, Newark, USA) presented these findings at the 30th annual scientific meeting of European Wound Management Association (EWMA; 18–19 November, online).
Mark Granick (Wound Care Center, University Hospital, Rutgers NJMS, Newark, USA), Alexander Reyzelman (Center for Clinical Research, California School of Podiatric Medicine, San Francisco, USA), and Thomas Serena (Serena Group, Cambridge, USA) are co-principal investigators of this study.
They set out to assess the efficacy of three silicone foam wound care dressings for the treatment of venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs) in the outpatient setting. In addition to the Mepilex Border Flex, the study investigators compared results from using Allevyn Life (Smith & Nephew) and Optifoam Gentle EX (Medline Industries).
Alvarez described Mepilex Border Flex as a bordered, five-layer, flexible foam dressing with soft silicone adhesive technology. Allevyn Life is a multi-layered, hydrocellular foam dressing also with silicone adhesive, and Optifoam Gentle EX is a hydropolymer, adhesive silicone foam, island dressing.
The investigators report a significantly greater seven-day wear time when Mepilex Border Flex was the dressing of choice compared to Allevyn Life (52.9% vs. 27.8%, respectively; p=0.046) or Optifoam Gentle EX (62.6% vs. 18.8%, respectively; p=0.01).
Study details: A 2×2 crossover design
Detailing the trial design, Alvarez told attendees: “This was designed to be a superiority comparison, favouring Mepilex Border Flex in statistical design. It was a prospective, randomised, and controlled [study], using a repeated measures design,” which is a crossover design that means each patient serves as their own control. In total, 41 patients were enrolled in the study, across three centres. All patients were randomised into one of four treatment groups. After two weeks of treatment, the patients were crossed over to use another wound dressing for the remaining two weeks.
The four treatment groups were: A) Allevyn Life for two weeks, then Mepilex Border Flex for two weeks; B) Mepilex Border Flex for two weeks, then Allevyn Life for two weeks; C) Optifoam Gentle EX for two weeks, then Mepilex Border Flex for two weeks; D) Mepilex Border Flex for two weeks, then Optifoam Gentle EX for two weeks.
The primary endpoint was wound dressing durability (measured in number of days), as determined by the incidence of strike-through. Strike-through was defined as the inability of the dressing to stay sealed over the wound, causing leakage of wound exudate. Alvarez informed EWMA delegates that this can be the result of saturation, loss of edge seal, or dislodgement due to friction in the wound dressing.
All study patients were seen at days three, seven, 10, and 14 post-treatment, when they were crossed over to a different silicone foam dressing, before being assessed on days 17, 21, 24, and 28 post-treatment. “Wound evaluations included wound measurements, clinical review of the patient and the wounds, adverse events and so forth, and patient-centric parameters, including a quality of life questionnaire [SF-12V2],” Alvarez said. Dressing evaluations included measurements of exudate absorption/ dispersion, and durability (incidence of strike-through).
Highest incidence of completely intact dressings seen with Mepilex Border Flex
The incidence of dressing strike-through during the first three days of treatment was lower when Mepilex Border Flex was used compared to either of the other two dressing options, a statistically significant finding. Strike-through incidence was 47.1% (eight of 17 wounds) with Mepilex Border Flex, compared to 72.2% (13 of 18 wounds) with Allevyn Life (p<0.05). In the head-to-head comparison with Optifoam Gentle EX, strike-through incidence was 37.5% (six of 16 wounds) for Mepilex Border Flex, and 81.3% (13 of 16 wounds) for Optifoam Gentle EX (p<0.05).
After one week of treatment, the incidence of completely intact dressings (i.e. those with no strike-through) was greater in the Mepilex Border Flex cohorts than either the Allevyn Life or Optifoam Gentle EX groups: 35.3% (13 of 33 wounds) when Mepilex Border Flex was used versus 5.6% (one of 18 wounds) when Allevyn Life was used (p<0.05), and 35.3% (13 of 33 wounds) again with Mepilex Border Flex versus 12.5% (two of 16) with Optifoam Gentle EX (p<0.05).
Showing the EWMA audience “characteristic” photographs of a diabetic foot being treated with a dressing, Alvarez said that the trajectory of healing remained unchanged regardless of the dressing used, with patients tolerating all three products well, and the size of every ulcer shrinking over the course of the study.
However, he went on to explain that there were some limitations to the study. The sample size was small, and there was a loss of follow-up of some patients whose wounds healed in under four weeks, he shared—indeed, one patients healed within two weeks, so was only treated with one dressing type. The majority of wounds were small (median: 2.02cm3), in good condition (63.2% had moderate exudate; 10.5% had heavy exudate), and already on a healing trajectory at baseline. “We were not looking for any really difficult situations with these,” Alvarez commented, “we just wanted to study the actual dressing behaviour on these normal wounds.”
Regardless of these limitations, these data support the conclusion that all three multi-layered silicone foam dressings evaluated are safe to use, as each was well-tolerated without any device-associated adverse events.