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A Randomized Controlled Clinical Trial to Evaluate the Effects of Noncontact Normothermic Wound Therapy on Chronic Full-thickness Pressure Ulcers

Kloth, Luther C. MS, PT, CWS, FAPTA; Berman, Joseph E. PT, ATC, MHS; Nett, Marilyn MPT; Papanek, Paula E. PhD, MPT, FACSM; Dumit-Minkel, Sonia MD, PT

Features: Original Investigation

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.

Luther C. Kloth, MS, PT, CWS, FAPTA, is Professor; Joseph E. Berman, PT, ATC, MHS, is Research Associate; Marilyn Nett, MPT, was Research Assistant at the time of the study; and Paula E. Papanek, PhD, MPT, FACSM, is Director of the Program in Exercise Science; Department of Physical Therapy, College of Health Sciences, Marquette University, Milwaukee, WI. Sonia Dumit-Minkel, MD, PT, is Senior Physical Therapist, Department of Physical Therapy, Zablocki Veterans Administration Medical Center, Milwaukee, WI.

The authors have disclosed that they have received grant/research support from Augustine Medical, Inc, Eden Prairie, MN.

Submitted November 15, 2001; accepted in revised form May 3, 2002.

ACKNOWLEDGMENTS

The authors acknowledge Roumyana Kirova, MSCS, Marquette University, Milwaukee, WI, for statistical assistance and George W. Cherry, DPhil (Oxon), the Oxford Wound Healing Institute, Oxford, UK, for review of the manuscript.

© 2002 Lippincott Williams & Wilkins, Inc.