Prospective Randomized Controlled Trial Comparing the Effects of Noncontact Low-Frequency Ultrasound with Standard Care in Healing Split-Thickness Donor Sites

Abstract

Background: Skin graft donor sites are notoriously painful, with potential complications of fluid loss, delayed healing, infection, and hypertrophic scarring, particularly in patients with burns or traumatic injury. In this population, rapid epithelialization is critical to reducing morbidity and cost.

Study design: This prospective, randomized controlled trial compared the effects of 40-kHz noncontact low-frequency ultrasound (NLFU) in addition to standard care (SC) with SC alone in subjects with split-thickness donor sites of 20 to 200 cm(2). Standard care consisted of cleansing and moist wound dressings. Outcomes measured were time to healing, defined as absence of drainage and full epithelialization; pain and itching scores; and recidivism rates.

Results: Of 33 patients enrolled; 27 were randomized and received a minimum of 4 study treatments. Median age was 49 years, 69% were male, and 84% were burn patients. Comorbidities included hypertension (31%), coronary artery disease (22%), pulmonary disease (38%), anemia (31%), and diabetes (16%). Median donor site area was 136.0 cm(2). Noncontact low-frequency ultrasound and SC compared with SC demonstrated a mean time to heal of 12.1 days vs 21.3 days (p = 0.04). All NLFU+SC subjects had epithelialized by 4 weeks compared with only 71% in SC. Recidivism rates were 8% for NLFU+SC compared with 45% for SC. Pain scores were reduced and significant differences in itching were observed.

Conclusions: Noncontact low-frequency ultrasound and SC compared with SC alone in the treatment of split-thickness donor sites demonstrated significant accelerated healing and reduced pain and itching. Noncontact low-frequency ultrasound subjects experienced a better quality of healing with less incidence of infection and recidivism.

Trial registration: ClinicalTrials.gov NCT01214980.