A prospective randomised controlled clinical trial comparing hydrosurgery debridement with conventional surgical debridement in lower extremity ulcers

Abstract

Debridement of devitalised tissue is an essential component of the effective treatment of chronic wounds. The Versajet Hydrosurgery System is a new technology that simultaneously cuts and aspirates soft tissue. In this study we compared Versajet with conventional surgical techniques in the debridement of lower extremity ulcers to assess impact on time and resources for debridement. Forty-one patients with a mean age of 68 years (range 33 to 95 years) underwent surgical debridement of a lower extremity ulcer. Operating room (OR) sessions were randomised to Versajet (n= 22) or conventional debridement (n= 19) with scalpel plus pulsed lavage. Procedure time and utilisation of consumables were recorded. Wound areas were monitored for 12 weeks. There was significant evidence (P < 0.008) of a shorter debridement time (10.8 min) using Versajet over conventional debridement (17.7 min); a mean saving of 6.9 minutes (39%). In addition, a significant reduction in use of pulsed lavage and saline (P < 0.001) was observed with Versajet. Overall, clinical efficacy of the shorter debridement procedure was similar: median time to wound closure 71 days (Versajet) vs. 74 days (conventional) (P= 0.733). We found Versajet to be quicker than conventional debridement in the debridement of lower extremity ulcers without compromising wound healing. Potential cost savings were identified from the use of VERSAJET through the shorter debridement time allowing more patients to be treated in the same operating schedule.

Figure 1

VERSAJET™ Hydrosurgery system in use. The VERSAJET (45° 14mm handpiece) in use on a lower extremity ulcer. The cutting chamber (14 mm) and the evacuation tube are on the lower surface of the instrument. The powered console and the hoses supplying high pressure fluid and removing fluid and waste are not visible.

Figure 2

Wound debridement times of first surgical debridement. The debridement times (skin to skin) were recorded in surgical debridement procedures that were randomised to either conventional scalpels and pulsed lavage or VERSAJET as described in Materials and Methods. The data from wounds were subsequently analysed in accordance with whether or not they contained black necrotic tissue. There was marginal statistical evidence (P= 0·098) that the difference between the treatment groups in wound debridement time depended on the area of black necrotic tissue.

Figure 3

Kaplan Meier plot of the probability of wound closure. Following debridement the wounds were followed with area tracing for 12 weeks if they had not subsequently healed. The probability of closure was calculated for VERSAJET (red line) and Conventional (blue line) as described in Materials and Methods.