P2-16-07: A Randomised Controlled Trial To Evaluate the Role of Tisseel, a Fibrin Sealant on Seroma Formation in Latissimus dorsi Breast Reconstruction.
Authors: ZE Winters, R Llewellyn-Bennett, R English, J Turner, Z Rayter, R Greenwood
Journal: Cancer Research (2011)

Abstract Introduction: Donor site seromas are common complications following Latissimus dorsi breast reconstructions (LDBR), as shown in the UK National Mastectomy and Breast Reconstruction audit. Level I clinical evidence following the performance of an RCT supports ‘fixation’ of the back skin flaps by quilting sutures1. Fibrin sealants (Tisseel) have been postulated to reduce seromas after simple mastectomy and axillary dissections2, but their role in reducing donor site seromas after breast reconstruction has yet to be performed in a ‘robust’ clinical trial. The aim of this RCT was to compare Tisseel against Control (no Tisseel) on the incidence of seromas after LDBR. Methods: In an ethics approved single centre, single-blinded study comprising 2 surgeons from 2005–2010; 106 women were randomised to either Control (52) or Tisseel (54) interventions after immediate or delayed breast reconstructions. Sixteen patient's were excluded as follows due to incomplete data at 3 months or re-operations of the donor site for complications. The types of breast reconstructions comprised implant-assisted LD (LDI) in 45 women, 23 extended LD flaps (ELD) and 23 ELD with implant (ELDI). Immediate breast reconstructions (n=87) comprised the majority compared to only 4 delayed procedures. Intraoperative drains were placed to the breast, axilla and donor site (x two) as per standard practice. A 0.5% fibrinogen concentration was used in a hydraulic hand-held Tisseel spray application to the donor site chest wall over 60 seconds. Two stay sutures were pre-placed 2 cm adjacent to the donor wound skin edges above and below prior to the Tisseel application. In the control group, 2 drains only were placed. The primary outcome measure was the total seroma volumes from all the sites over 3 months. This was used for the power calculation of the sample size and showed a requirement for a minimum of 95 women. Secondary outcomes included the volumes of the donor site seromas, and the frequency of post-drain removal donor site aspirations of all symptomatic seromas by patient self-report. Results: The effect of Tisseel glue was to reduce the mean total drain (breast, axilla and back) volume from 2170ml to 1919ml (P=0.05, Mann-Whitney) within 7–10 days. The donor site seroma volumes were similar between the 2 groups over 3 months. The mean donor site total drain volumes (LD donor site drain volume and symptomatic donor site aspirations) were 5412ml in the Control group (840-6252), compared to the Tisseel group producing 4646ml (5384-738). There were no statistical differences between the frequencies or volumes of patient reported seromas aspirated post-drain removal between the two groups. This comprised a mean of 4 aspirations (range 0–13) in the Control group compared to a mean of 9 aspirations (range 0–11) after the use of Tisseel (P=0.548). Conclusion: Tisseel glue may reduce the ‘early’ effect of seroma development, but has not shown any significant role in minimising the potential ‘shearing’ of the donor site skin flaps causing later seroma formation. Current evidence recommends quilting sutures as the gold-standard in reducing this complication. 1. Daltrey I et. al. BJS 2006; 93(7):825–830. 2. Jain PK et. al. BJS 2004; 91:54–60. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P2-16-07.