Prospective clinical study of a new adhesive gelling foam dressing in pressure ulcers.
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.
Parish
Lawrence Charles
LC
Department of Dermatology and Cutaneous Biology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, PA, USA. larryderm@yahoo.com
Dryjski
Maciej
M
Cadden
Sue
S
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D047070:Bandages, Hydrocolloid / Q000009:adverse effects; D002266:Carboxymethylcellulose Sodium / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D011140:Polyurethanes / Q000009:adverse effects; D003668:Pressure Ulcer / Q000473:pathology / Q000628:therapy*; D011446:Prospective Studies; D016896:Treatment Outcome; D014945:Wound Healing
D005782:Gels; D011140:Polyurethanes; D002266:Carboxymethylcellulose Sodium