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

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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. / Schmid, Sebastian C; Seitz, Anna K; Haller, Bernhard; Fritsche, Hans-Martin; Huber, Toni; Burger, Maximilian; Gschwend, Jürgen E; Maurer, Tobias.

In: WORLD J UROL, Vol. 39, No. 2, 02.2021, p. 613-620.

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@article{00a2b4f9553c48009be22190ce337d74,
title = "Final results of the Pr{\"a}VAC 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.",
author = "Schmid, {Sebastian C} and Seitz, {Anna K} and Bernhard Haller and Hans-Martin Fritsche and Toni Huber and Maximilian Burger and Gschwend, {J{\"u}rgen E} and Tobias Maurer",
year = "2021",
month = feb,
doi = "10.1007/s00345-020-03221-z",
language = "English",
volume = "39",
pages = "613--620",
journal = "WORLD J UROL",
issn = "0724-4983",
publisher = "Springer",
number = "2",

}

RIS

TY - JOUR

T1 - 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

AU - Schmid, Sebastian C

AU - Seitz, Anna K

AU - Haller, Bernhard

AU - Fritsche, Hans-Martin

AU - Huber, Toni

AU - Burger, Maximilian

AU - Gschwend, Jürgen E

AU - Maurer, Tobias

PY - 2021/2

Y1 - 2021/2

N2 - 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.

AB - 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.

U2 - 10.1007/s00345-020-03221-z

DO - 10.1007/s00345-020-03221-z

M3 - SCORING: Journal article

C2 - 32372159

VL - 39

SP - 613

EP - 620

JO - WORLD J UROL

JF - WORLD J UROL

SN - 0724-4983

IS - 2

ER -