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)

Melinda M Mortenson, Yan Xing, Storm Weaver, Jeffrey E Lee, Jeffrey E Gershenwald, Anthony Lucci, Paul F Mansfield, Merrick I Ross, Janice N Cormier, Melinda M Mortenson, Yan Xing, Storm Weaver, Jeffrey E Lee, Jeffrey E Gershenwald, Anthony Lucci, Paul F Mansfield, Merrick I Ross, Janice N Cormier

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.

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