A prospective, randomised, intra-patient, comparative, open, multi-centre study to evaluate the efficacy of a Single-Use Negative Pressure Wound Therapy (NPWT) System* on the prevention of postsurgical incision healing complications in patients undergoing

Objectives: To assess the effects of a Single-Use Negative Pressure Wound Therapy (suNPWT) System with regard to reduction of post-surgical complications and to assess the medium-term aesthetic appearance and scar quality in bilateral reduction mammoplasty patients.

Methods: Patients who were undergoing an elective surgical procedure for bilateral reduction mammoplasty and whose incisions were suitable for the treatment with NPWT were evaluated. All patients were; >18 years of age, non-pregnant females. Each patient was treated with both suNPWT System and Standard Care for up to 14 days, to enable a within patient comparison.

Results: 200 patients entered into the evaluation.  Within 21 days of surgery 10 (5.0%) fewer incisions developed a healing complication on suNPWT compared to Standard Care, (p-value = 0.004, 95% confidence interval of the difference 2.0% to 9.2%). The term ‘healing complication’ refers to the primary variable of delayed wound, dehiscence or infection with 21 days of surgery. In a sensitivity analysis, where the definition of delayed healing was extended from incision not closed within 7 days to incision not closed within 10 days, 10 (5.0%) fewer incisions developed a healing complication on suNPWT compared to Standard Care, (p=0.033, 95% confidence interval of the difference 0.4% to 10.1%). There was significant evidence for fewer healing complications on suNPWT compared to Standard Care treatment; the effect size of 5.0% was consistent for both the primary and the sensitivity analysis. Scar quality as measured by the VAS and POSAS scoring systems was shown to be significantly better on suNPWT treatment than Standard Care, both at the 42 day and 90 day assessment (p<0.001).

Conclusions: The results from this study are extremely positive with regard to a statistically significant reduction in incision healing complications and a statistically significant improvement in scar quality using the suNPWT system.