Prospective clinical study of a new adhesive gelling foam dressing in pressure ulcers

Abstract

This prospective, non comparative study evaluated the safety and effectiveness of an adhesive gelling foam dressing in pressure ulcer management. Twenty-three subjects with exuding pressure ulcers were recruited from seven centres in the USA and Canada. Study treatment included an adhesive gelling foam dressing, optional tape/roll bandaging and mandatory pressure-reducing/relieving devices. Subjects were followed until ulcer healing, for up to 28 days, or on patient withdrawal from the study, whichever came first. Dressings were changed at least once every 7 days. Mean percentage change in ulcer area from baseline to final measurement was -13%. Investigators reported healing or subjective improvement of ulcer condition in 61% of patients. Mean dressing wear time was 4.2 days. Subjects found the dressing was comfortable, soothing and cushioning in situ at 80%, 64% and 70% of dressing changes, respectively. Subjects reported pain severity of none or mild for every dressing change. Fourteen subjects experienced adverse events, including seven subjects with study-related maceration, erythema, wound enlargement, blister or infection. A regimen including an adhesive gelling foam dressing proved to be safe and effective for managing exudate, protecting the surrounding skin, minimising pain and supporting healing of pressure ulcers with exudate.

Figure 1

Cross section of adhesive gelling foam wound dressing (GFD‐A) at the edge of a wound. The Hydrofiber island (white) gels on contact with the wound bed to provide a moist wound healing environment (red) and manages exudate to minimise lateral spread of fluid to the periwound area. The hydrocolloid adhesive layer (tan) holds the dressing in place and gels on contact with wound fluid. The polyurethane film/foam outer surface layer (beige) also helps to cushion the wound. Picture reprinted with permission from E.R. Squibb & Sons, L.L.C.

Figure 2

Subject disposition. All enrolled subjects were included in safety and effectiveness analyses. Most subjects completed the 28‐day study period.

Figure 3

Exudate management. Investigators rated wear time and avoidance of leakage for each subject at the final evaluation (n= 23) (the final evaluation was performed at the final visit for all patients, including the early discontinuation visit for patients who did not complete the study). The majority of scores were either excellent or good for both outcomes.

Figure 4

Dressing performance. Investigators rated protection of surrounding skin, ease of application, ease of removal and conformability for each subject at the final evaluation (n= 23) (the final evaluation was performed at the final visit for all patients, including the early discontinuation visit for patients who did not complete the study). Most scores were either excellent or good for each measure of dressing performance.

Figure 5

Dressing comfort in situ. At each clinic dressing change (n= 128), most of the subjects reported the adherent gelled foam dressing was comfortable, soothing or cushioning. Subjects were unable to respond to a question at 20–30% of study visits. More than 90% of recorded responses confirmed the dressing was comfortable, soothing or cushioning.