Final results of the PräVAC trial: prevention of wound complications following inguinal lymph node dissection in patients with penile cancer using epidermal vacuum-assisted wound closure

Abstract

Purpose Inguinal lymphadenectomy in penile cancer is associated with a high rate of wound complications. The aim of this trial was to prospectively analyze the effect of an epidermal vacuum wound dressing on lymphorrhea, complications and reintervention in patients with inguinal lymphadenectomy for penile cancer. Patients and methods Prospective, multicenter, randomized, investigator-initiated study in two German university hospitals (2013-2017). Thirty-one patients with penile cancer and indication for bilateral inguinal lymph node dissection were included and randomized to conventional wound care on one side (CONV) versus epidermal vacuum wound dressing (VAC) on the other side. Results A smaller cumulative drainage fluid volume until day 14 (CDF) compared to contralateral side was observed in 15 patients (CONV) vs. 16 patients (VAC), with a median CDF 230 ml (CONV) vs. 415 ml (VAC) and a median maximum daily fluid volume (MDFV) of 80 ml (CONV) vs. 110 ml (VAC). Median time of indwelling drainage: 7 days (CONV) vs. 8 days (VAC). All grade surgery-related complications were seen in 74% patients (CONV) vs. 74% patients (VAC); grade 3 complications in 3 patients (CONV) vs. 6 patients (VAC). Prolonged hospital stay occurred in 32% patients (CONV) vs. 48% patients (VAC); median hospital stay was 11.5 days. Reintervention due to complications occurred in 45% patients (CONV) vs. 42% patients (VAC). Conclusions In this prospective, randomized trial we could not observe a significant difference between epidermal vacuum treatment and conventional wound care.

Cochrane in CORR®: Negative Pressure Wound Therapy for Surgical Wounds Healing by Primary Closure

“…The Cochrane reviewers rated down the quality of evidence for imprecision, high risk of bias in various domains, and inconsistency across domains, with approximately half of the studies using methods likely to introduce error. Additionally, a number of studies were terminated prematurely due to skin blistering [8,19] and futility (low chance of a positive result, although not a negative result) [10,17,19]. These studies were included for analysis and may skew the overall findings.…”