The impact of negative‐pressure wound therapy with instillation on wounds requiring operative debridement: Pilot randomised, controlled trial
Paul J. Kim, Lawrence A. Lavery, Robert D. Galiano, Christopher J. Salgado, Dennis P. Orgill, Stephen J. Kovach, Brent Bernstein, Christopher E. Attinger
Abstract
Abstract Presence of bacteria in wounds can delay healing. Addition of a regularly instilled topical solution over the wound during negative‐pressure wound therapy (NPWT) may reduce bioburden levels compared with standard NPWT alone. We performed a prospective, randomised, multi‐centre, post‐market trial to compare effects of NPWT with instillation and dwell of polyhexamethylene biguanide solution vs NPWT without instillation therapy in wounds requiring operative debridement. Results showed a significantly greater mean decrease in total bacterial counts from time of initial surgical debridement to first dressing change in NPWT plus instillation (n = 69) subjects compared with standard NPWT (n = 63) subjects (−0.18 vs 0.6 log 10 CFU/g, respectively). There was no significant difference between the groups in the primary endpoint of required inpatient operating room debridements after initial debridement. Time to readiness for wound closure/coverage, proportion of wounds closed, and incidence of wound complications were similar. NPWT subjects had 3.1 times the risk of re‐hospitalisation compared with NPWT plus instillation subjects. This study provides a basis for exploring research options to understand the impact of NPWT with instillation on wound healing.