Interim Analysis of a Prospective, Randomized Trial of Vacuum-Assisted Closure Versus the Healthpoint System in the Management of Pressure Ulcers

TLDR

In a randomized 6‑week trial of 28 patients with 41 full‑thickness decubitus ulcers, 22 patients with 35 ulcers completed treatment with either a vacuum‑assisted closure device (VAC) or the Healthpoint System (HP) wound gel products. At 6 weeks, complete healing was observed in 10% of VAC patients and 13% of HP patients, with mean ulcer volume reductions of 51.8% for VAC versus 42.1% for HP (p = 0.46), and VAC produced more favorable histologic changes, including higher capillary density and improvement in osteomyelitis cases, whereas HP showed no osteomyelitis improvement.

Abstract

In Brief Twenty-eight patients with 41 full-thickness decubitus ulcers were randomized to compare the Vacuum-Assisted Closure device (VAC) with the Healthpoint System (HP) of wound gel products in promoting ulcer healing. A total of 22 patients with 35 full-thickness ulcers completed the 6-week trial of treatment, during which time 2 patients (10%) in the VAC group (N =20) and 2 patients (13%) in the HP group (N = 15) healed completely. The mean percent reduction in ulcer volume was 42.1% with HP and 51.8% with VAC (p = 0.46). The mean number of PMNs and lymphocytes per high-power field decreased in the VAC group and increased in the HP group (p = 0.13, p = 0.41 respectively). The mean number of capillaries per high-power field was greater in the VAC group (p = 0.75). There were 15 cases of biopsy-proven osteomyelitis underlying the ulcers; three (37.5%) improved with VAC and none improved with HP (p = 0.25). VAC promotes an increased rate of wound healing and favorable histological changes in soft tissue and bone compared with HP. In a randomized study, 22 patients with 35 full-thickness pressure ulcers completed treatment with either a vacuum-assisted device or a combination gel system of wound care. Although there was no difference between the two systems in wound shrinkage or complete healing, the vacuum device demonstrated more favorable histologic changes.