Abstract
BackgroundSeroma formation is a common complication after mastectomy and is associated with delayed wound healing, infection, skin flap necrosis, patient discomfort and repeated visits to the out patient clinic to deal with seroma and its sequelae. Closing the dead space after mastectomy seems to be key in reducing seroma and its complications. Various methods have been described to reduce the dead space after mastectomy: closed suction drainage, quilting of the skin flaps and application of adhesive tissue glues. The aim of this trial is to compare seroma formation and its sequelae in the various methods of flap fixation.MethodsThis is a multicenter, double-blind, randomized controlled trial in female breast cancer patients undergoing mastectomy, with or without axillary clearance. Exclusion criteria consist of breast conserving therapy, direct breast reconstruction and incapacity to comprehend implications and extent of study and unable to sign for informed consent. A total of 336 patients will be randomized. Patients will be randomly allocated to one of three treatment arms consisting of flap fixation using ARTISS tissue glue with a low suction drain, flap fixation using sutures and a low suction drain or conventional wound closure (without flap fixation) and low suction drainage. Follow up will be conducted up to twelve months post surgery. The primary outcome is the number of seroma aspirations and secondary outcomes consist of number of out patient clinic visits, surgical skin infection rate, shoulder function, cosmesis, health-related quality of life and costs and cost-effectiveness (cost/QALY).DiscussionThis is the first study of its kind to evaluate the effect of flap fixation and its sequelae (ie seroma aspirations, number of out patient clinic visits, infection, shoulder function, patient assessed cosmesis, quality of life and cost-effectiveness) in a double blind randomized controlled trial.Trial registrationThis trial was approved by the hospitals’ joint medical ethical committee (14-T-21, 2 June 2014). The SAM Trial is registered in ClinicalTrials.gov since October 2017, Identifier: NCT03305757.
Highlights
Seroma formation is a common complication after mastectomy and is associated with delayed wound healing, infection, skin flap necrosis, patient discomfort and repeated visits to the out patient clinic to deal with seroma and its sequelae
Until now one prospective randomized controlled trial has been published showing a significant reduction of seroma formation and seroma related complications after flap fixation using quilting sutures [21]
A review published by Van Bastelaar et al concluded that mechanical flap fixation seems to reduce seroma formation and seroma aspiration after mastectomy with or without axillary clearance
Summary
Study design The SAM (Seroma reduction After Mastectomy) Trial is a double blind randomized controlled trial. It is expected that patients with higher levels of the early systemic inflammatory response markers in seroma might suffer from increased seroma formation The aim of this sampling was to assess if there was any association between IL-6 and TNF-α levels in seroma fluid measured on the first postoperative day and seroma and seroma related complications in patients undergoing mastectomy with or without flap fixation. Patients and surgeons will be questioned during every postoperative follow up appointment on the presumed method of closure In this fashion, one will be able to assess whether double blind randomization is realistic upon evaluation. Sample size estimation based on ordinal regression is in line with the data distribution and limited possibilities (maximum number of aspirations in the observational retrospective study was 4) of the outcome variable Research findings will be submitted to peer-reviewed journals regardless of whether results are statistically significant
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
