Fibrin sealant does not decrease seroma output or time to drain removal following inguino-femoral lymph node dissection in melanoma patients: a randomized controlled trial (NCT00506311)

World J Surg Oncol. 2008 Jun 18:6:63. doi: 10.1186/1477-7819-6-63.

Abstract

Background: This study assessed the impact of closed suction drains and evaluated whether the intraoperative use of a fibrin sealant decreased time to drain removal and wound complications in melanoma patients undergoing inguino-femoral lymph node dissection.

Methods: A pilot study (n = 18) assessed the impact of a closed suction drain following inguino-femoral lymph node dissection. A single-institution, prospective trial was then performed in which patients were randomized to a group that received intraoperative application of a fibrin sealant following inguino-femoral lymph node dissection or to a control group that did not receive sealant.

Results: The majority of the patients enrolled felt the drains caused moderate or severe discomfort and difficulties with activities of daily living. Thirty patients were then randomized; the median time to drain removal in the control group (n = 14) was 30 days (range, 13-74) compared to 29 days (range, 11-45) in the fibrin sealant group (n = 16; P = 0.6). Major and minor complications were similar in the two groups.

Conclusion: Postoperative closed suction drains were associated with major patient inconvenience. Applying a fibrin sealant at the time of inguino-femoral lymph node dissection in melanoma patients did not reduce the time to drain removal or postoperative morbidity. Alternative strategies are needed.

Trial registration: ClinicalTrials.gov NCT00506311.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Cost-Benefit Analysis
  • Female
  • Fibrin Tissue Adhesive / economics
  • Groin
  • Humans
  • Lymph Node Excision / adverse effects*
  • Lymph Node Excision / economics
  • Male
  • Melanoma / pathology*
  • Melanoma / surgery
  • Middle Aged
  • Pilot Projects
  • Prospective Studies
  • Seroma / etiology
  • Seroma / prevention & control*
  • Skin Neoplasms / pathology*
  • Skin Neoplasms / surgery
  • Suction
  • Time Factors
  • Tissue Adhesives / economics

Substances

  • Fibrin Tissue Adhesive
  • Tissue Adhesives

Associated data

  • ClinicalTrials.gov/NCT00506311