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Randomized Controlled Trial
. 2021 Feb;39(2):613-620.
doi: 10.1007/s00345-020-03221-z. Epub 2020 May 5.

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

Sebastian C Schmid #  1 , Anna K Seitz #  2 , Bernhard Haller  3 , Hans-Martin Fritsche  4 , Toni Huber  4 , Maximilian Burger  4 , Jürgen E Gschwend  5 , Tobias Maurer  5   6
Affiliations
Randomized Controlled Trial

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

Sebastian C Schmid et al. World J Urol. 2021 Feb.

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.

Keywords: Closed incision negative pressure; Inguinal surgery; Lymphorrhea; Penile cancer; PraeVac.

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Conflict of interest statement

All authors declare no conflict of interest.

Figures

Fig. 1
Fig. 1
Epidermal vacuum treatment of the groin with the “PREVENA™ Incision Dressing” system, which is applied on the closed wound
Fig. 2
Fig. 2
Box plot (left) and scatter plot (right) of cumulative drainage fluid in the VAC vs. CONV group
Fig. 3
Fig. 3
Box plot (left) and scatter plot (right) of maximum daily fluid volume in the VAC vs. CONV group
Fig. 4
Fig. 4
Frequency of complications by grade (CTCAE 4.0) in the VAC vs. CONV group
See this image and copyright information in PMC

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