Randomized clinical trial on the effect of fibrin sealant on latissimus dorsi donor-site seroma formation after breast reconstruction

• Published in: British journal of surgery Vol. 99; no. 10; pp. 1381 - 1388
• Main Authors: Llewellyn-Bennett, R., Greenwood, R., Benson, J. R., English, R., Turner, J., Rayter, Z., Winters, Z. E.
• Format: Journal Article
• Language: English
• Published: Chichester, UK John Wiley & Sons, Ltd 01.10.2012; Wiley; Oxford University Press
• Subjects: Adult; Aged; Back; Biological and medical sciences; Breast Neoplasms - surgery; Clinical trials; Female; Fibrin Tissue Adhesive - therapeutic use; General aspects; Hematoma - etiology; Humans; Knee; Mammaplasty - adverse effects; Mammaplasty - methods; Mastectomy; Mastectomy - methods; Medical sciences; Middle Aged; Necrosis - etiology; Prospective Studies; Sealing compounds; Seroma - etiology; Seroma - prevention & control; Surgical Flaps; Surgical Wound Dehiscence - etiology; Surgical Wound Infection - etiology; Tissue Adhesives - therapeutic use; Treatment Outcome; Seroma; Donor site; Surgical glue; Fibrin glue; Latissimus dorsi muscle; Medicine; Plasty; Randomization; Rapid technique; Treatment; Surgery; Breast; Hemostatic adhesive; Clinical trial; Mammary gland; Formation
• ISSN: 0007-1323; 1365-2168
• DOI: 10.1002/bjs.8874

Background: Latissimus dorsi (LD) flap procedures comprise 50 per cent of breast reconstructions in the UK. They are frequently complicated by seroma formation. Fibrin sealants may reduce seroma volumes at the donor site. The aim was to investigate the effect of fibrin sealant (Tisseel®) on total seroma volumes from the breast, axilla and back (donor site) after LD breast reconstruction. Secondary outcomes were specific back seroma volumes together with incidence and severity of wound complications. Methods: Consecutive women undergoing implant‐assisted or extended autologous LD flap reconstruction were randomized to either standard care or application of fibrin sealant to the donor‐site chest wall. All participants were blinded for the study duration but assessors were only partially blinded. Non‐parametric methods were used for analysis. Results: A total of 107 women were included (sealant 54, control 53). Overall back seroma volumes were high, with no significant differences between control and sealant groups over 3 months. Fibrin sealant failed to reduce in situ back drainage volumes in the 10 days after surgery, and did not affect the rate or volume of seromas following drain removal. Conclusion: This randomized study, which was powered for size effect, failed to show any benefit from fibrin sealant in minimizing back seromas after LD procedures. Copyright © 2012 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. No advantage