Interim analysis of a prospective, randomized trial of vacuum-assisted closure versus the healthpoint system in the management of pressure ulcers.

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.

RCT Entities:   Population Interventions Outcomes