An extracellular matrix graft (Oasis® wound matrix) for treating full-thickness pressure ulcers: A randomized clinical trial.

AIM: The purpose of the study was to evaluate clinical safety and effectiveness of Oasis® Wound Matrix as a treatment for full-thickness pressure ulcers and compare it to Standard Care. METHODS: A total of 130 adults with Stage III or Stage IV pressure ulcers were randomly assigned, received either multiple topical treatments of SIS plus standard care (n = 67), or standard care alone (n = 63), and were subsequently evaluated. Ulcer size was determined at enrollment and weekly throughout treatment. Healing was assessed at each visit for a period of up to 12 weeks, with incidence of complete healing and 90% reduction in ulcer area being the primary outcome measures. RESULTS: The proportion of complete healing in the SIS group was 40% as compared to 29% in the standard of care group (p = 0.111); the percentage of patients having a 90% reduction in ulcer surface area was 55% in the SIS group versus 38% in the standard of care group (p = 0.037). CONCLUSIONS: The results of this study suggest that within the setting of a comprehensive wound care program, weekly treatment of chronic pressure ulcers with SIS wound matrix increases the incidence of 90% reduction in wound size versus standard of care alone.

A prospective, randomized clinical trial to assess the cost-effectiveness of a modern foam dressing versus a traditional saline gauze dressing in the treatment of stage II pressure ulcers.

Modern dressings such as hydrocolloids, gels, and foams are typically more expensive than traditional dressings such as gauze. However, if modern dressings require fewer changes, the overall cost of treatment may be lower despite the higher initial purchase price. If healing rates are comparable or better, modern dressings also may be cost-effective. A 4-week, prospective, randomized clinical trial to assess differences in treatment costs and cost-effectiveness between a modern foam dressing and saline-soaked gauze was conducted among 36 patients (22 men, 14 women, mean age 72.8 years) with a Stage II pressure ulcer (mean duration 35 weeks) at five centers in the United States. Participants were randomized to treatment with a self-adhesive polyurethane foam (n = 20) or saline-soaked gauze dressing (n = 16). No difference in time to wound closure was observed (P = 0.817). Patients in the foam group had less frequent dressing changes (P <0.001). Total cost over the study period was lower by $466 per patient (P = 0.055) and spending on dressings was lower by $92 per patient in the foam group (P = 0.025). Cost per ulcer healed was lower by $1,517 and cost per ulcer-free day was lower by $80 for patients in the foam group. On the evidence of this study, the foam dressing is a more cost-effective treatment than saline-soaked gauze for the treatment of Stage II pressure ulcers.

A prospective, randomized, multisite clinical evaluation of a transparent absorbent acrylic dressing and a hydrocolloid dressing in the management of Stage II and shallow Stage III pressure ulcers.

OBJECTIVE: To compare clinical performance of a transparent absorbent acrylic dressing (3M Tegaderm Absorbent Clear Acrylic Dressing ]TAAD[; 3M Company, St Paul, MN) and a hydrocolloid dressing (HD ]DuoDERM CGF, ConvaTec, ER Squibb & Sons, Princeton, NJ[) in the management of Stage II and shallow Stage III pressure ulcers. DESIGN: Prospective, open-label, randomized, comparative, multisite clinical evaluation. Patients were followed up for a maximum of 56 days or until their ulcer healed. At weekly intervals, investigators conducted wound assessments and dressing performance evaluations. SETTING: Wound care clinics, home care, and long-term care. PATIENTS: Thirty-five patients received the TAAD, and 37 received the HD. OUTCOME MEASURES: Dressing performance assessments, patient comfort, dressing wear time, and wound healing were measured. RESULTS: The majority of investigator assessments favored the TAAD. Considerations given included the ability to center dressings over the ulcer (P = .005), ability to assess the ulcer before (P < .001) and after (P < .001) absorption, barrier properties (P = .039), patient comfort during removal (P < .001), overall patient comfort (P = .048), conformability before (P = .026) and after (P = .001) absorption, ease of removal (P < .001), nonadherence to wound bed (P < .001), residue in the wound (P = .002), residue on periwound skin (P < .001), and odor after absorption (P = .016). Overall satisfaction favored the TAAD (P < .001), and a high value was placed on its transparent feature (P < .001). Mean (SD) wear time for the TAAD was 5.7 (2.55) days compared with 4.7 (2.29) days for the HD (P = .086). This 1-day difference in wear time was clinically noticeable by the investigators (P = .035). Wound closure for the 2 dressing groups was nearly identical (P = .9627). CONCLUSIONS: Performance results favored the TAAD over the HD as standard treatment for Stage II and shallow Stage III pressure ulcers.