A randomized controlled clinical trial to evaluate the effects of noncontact normothermic wound therapy on chronic full-thickness pressure ulcers

Abstract

Objective: To determine the effect of noncontact normothermic wound therapy (NNWT) versus standard wound care on chronic full-thickness pressure ulcers.

Design: Prospective, randomized, controlled trial.

Setting: Veterans administration medical center and 7 long-term-care facilities.

Patients: 40 inpatients with 43 Stage III and IV pressure ulcers.

Interventions: A sterile noncontact wound dressing was applied to 21 wounds for 24 hours per day, 7 days per week. Each day after the wound was irrigated and the noncontact dressing was changed, a heating element in the dressing was activated for 3 1-hour periods for 12 weeks or until wound closure. Twenty-two control wounds were treated with standard, moisture-retentive dressings 24 hours per day, 7 days per week for 12 weeks or until wound closure.

Main outcome measure: Measurement of wound surface area.

Main results: Healing rate for the NNWT group was significantly greater than for the control group (0.52 cm2 per week and 0.23 cm2 per week, respectively; P<.02). A clinically significant increase was seen among the NNWT group in the incidence of closure among wounds that completed the entire 12-week protocol compared with controls (11 of 14 or 79% and 8 of 16 or 50%, respectively; not significant). The mean slope of the individual regression analyses for the NNWT group was significantly different from the mean slope for the control group (-0.07 and -0.033, respectively; P<.05). Large wounds in the NNWT group demonstrated a significantly greater healing rate than large wounds in the control group (P <.05).

Conclusion: Wounds treated with NNWT healed significantly faster than wounds in the control group. The healing rate was greatest for larger wounds treated with NNWT.