Comparison of standard surgical debridement versus the VERSAJET Plus™ Hydrosurgery system in the treatment of open tibia fractures: a prospective open label randomized controlled trial

Abstract

The aim of this study was to assess the efficacy of an alternative debridement technology in the treatment of Gustilo & Anderson grade III A and III B open tibia fractures. The objective was to explore whether improvements to the debridement using tangential hydrosurgery (VERSAJET™ Plus Smith & Nephew) could reduce the number of debridement episodes and the days before closure. A pilot scale randomized controlled trial was conducted against conventional surgery. A total of 40 patients were recruited. Sixteen patients received hydrosurgery and 24 patients were treated with standard surgical debridement. Baseline characteristics were well balanced. There was significant evidence (p < 0.001) that VERSAJET patients required fewer debridement procedures than standard surgical debridement prior to wound closure (ratio standard: VERSAJET = 1.747). The median time to wound closure was 3 days (95% CI 3 days, 5 days) for VERSAJET and 5 days (95% CI 4 days, 8 days) for standard debridement, although the difference was not statistically significant (p = 0.275). There were no instances of post-operative infection.

Keywords: Open fracture; VERSAJET; debridement; hydrosurgery.

Figure 1

Illustration of the use of VERSAJET in this study: A. In both Standard and VERSAJET groups the wounds were extended with a scalpel where necessary. B. VERSAJET debridement was applied to all exposed areas of soft tissue. In the Standard group a scalpel was used to remove non-viable or contaminated tissue. C. In both Standard and VERSAJET groups where necessary the wound edges were formalized with a scalpel in preparation for delayed surgical closure. D. VERSAJET debridement was again applied to all exposed areas of soft tissue and bone ends following debridement of the medullary canal with a Volkman spoon. The image is a single frame taken from a video of the procedure at the point of contact with the bone end. This intercepts the fluid jet resulting in the momentary “gush” of fluid which is aspirated by the suction a few seconds later.

Figure 2

Number of debridements. Proportions of patients that achieved stable closure following 1, 2 or 3 debridement procedures as described in Materials and Methods in the VERSAJET or standard debridement groups.

Figure 3

Kaplan-Meyer analysis of median time to closure. The estimates of the median time to wound closure was 3 days (95% CI (3 days, 5 days)) for VERSAJET and 5 days (95% CI (4 days, 8 days) for standard surgically debrided wounds, but the difference was not statistically significant (p = 0.275).