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01-05-2019 | Wound Dehiscence | Gynecologic Oncology

Efficacy of a collagen-fibrin sealant patch (TachoSil®) as adjuvant treatment in the inguinofemoral lymphadenectomy for vulvar cancer: a double-blind randomized-controlled trial

Authors: Silvia Baggio, Antonio Simone Laganà, Simone Garzon, Matteo Scollo, Ricciarda Raffaelli, Saverio Tateo, Fabio Ghezzi, Massimo Franchi

Published in: Archives of Gynecology and Obstetrics | Issue 5/2019

Abstract

Purpose

To evaluate the effect of a collagen-fibrin sealant patch (TachoSil®) in preventing postoperative complications after inguinofemoral lymphadenectomy for vulvar cancer.

Methods

Double-blind randomized-controlled trial on consecutive patients undergoing bilateral inguinofemoral lymphadenectomy for vulvar cancer. Intraoperatively, inguinofemoral areas were randomized: one was treated with TachoSil®, while the contralateral had standard closure without collagen-fibrin sealant patch. Surgical outcomes, amount of drainage volume, duration of drain placement, and any postoperative complication (vulvar wound dehiscence, inguinal wound dehiscence, cellulitis, lymphangitis, lymphoceles, and hematoma) were recorded. Leg measurements were taken preoperatively and during postoperative follow-up until 6 months to evaluate lymphedema.

Results

A total of 19 patients were enrolled and 38 inguinofemoral dissections were performed. There was no significant difference between the investigational and control arm in the amount of drainage volume (p = 0.976), and duration of drain placement (p = 0.793). The postoperative complications, excluding lymphedema, were 10/19 (53%) in investigational arm and 9/19 (47%) in control arm (p = 0.74). At the end of follow-up, the prevalence of grade 1 lymphedema was 44.4% and 50% in investigational and control arm, respectively (p = 0.744); grade 2 and 3 lymphedema had a prevalence of 33.3% in both arms (p = 1).

Conclusion

Application of TachoSil® does not seem to improve postoperative lymphorrhagia nor to reduce the incidence of postoperative complications in patients undergoing inguinofemoral lymphadenectomy for vulvar cancer. Considering this point, it would be useful to identify additional strategies in inguinofemoral dissection for the prevention of these complications.

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Title: Efficacy of a collagen-fibrin sealant patch (TachoSil®) as adjuvant treatment in the inguinofemoral lymphadenectomy for vulvar cancer: a double-blind randomized-controlled trial
Authors: Silvia Baggio
Antonio Simone Laganà
Simone Garzon
Matteo Scollo
Ricciarda Raffaelli
Saverio Tateo
Fabio Ghezzi
Massimo Franchi
Publication date: 01-05-2019
Publisher: Springer Berlin Heidelberg
Keywords: Wound Dehiscence
Lymphangitis
Vulvar Cancer
Lymphedema
Vulvar Cancer
Lymphadenectomy
Published in: Archives of Gynecology and Obstetrics / Issue 5/2019
Print ISSN: 0932-0067
Electronic ISSN: 1432-0711
DOI: https://doi.org/10.1007/s00404-019-05113-z

At a glance: The STEP trials

Springer Medicine

Efficacy of a collagen-fibrin sealant patch (TachoSil®) as adjuvant treatment in the inguinofemoral lymphadenectomy for vulvar cancer: a double-blind randomized-controlled trial

Abstract

Purpose

Methods

Results

Conclusion

At a glance: The STEP trials

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

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