A multi-center, double blind randomized controlled trial evaluating flap fixation after mastectomy using sutures or tissue glue versus conventional closure: protocol for the Seroma reduction After Mastectomy (SAM) trial

Autor: Renée W Y Granzier, Yvonne L. J. Vissers, Carmen D. Dirksen, Geerard L. Beets, L.M. van Roozendaal, J. van Bastelaar
Přispěvatelé: RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Promovendi ODB, Surgery, RS: CAPHRI - R2 - Creating Value-Based Health Care, Health Services Research, MUMC+: KIO Kemta (9)
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Cancer Research
DRAINAGE
Cost effectiveness
Mammaplasty
medicine.medical_treatment
Tissue glue
Surgical Flaps
law.invention
Study Protocol
QALY
Postoperative Complications
0302 clinical medicine
Randomized controlled trial
law
Axilla/physiopathology
Flap fixation
030212 general & internal medicine
DISSECTION
Postoperative Complications/physiopathology
Mastectomy
Quilting
Seroma formation
Middle Aged
Fibrin Tissue Adhesive/therapeutic use
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
BREAST-CANCER SURGERY
Surgical Flaps/standards
Breast Neoplasms/physiopathology
Treatment Outcome
medicine.anatomical_structure
Shoulder function
Oncology
Seroma/pathology
030220 oncology & carcinogenesis
Female
Breast reconstruction
Adult
medicine.medical_specialty
Mammaplasty/methods
Breast Neoplasms
Fibrin Tissue Adhesive
lcsh:RC254-282
03 medical and health sciences
Double-Blind Method
Genetics
medicine
Humans
Aged
business.industry
DEAD SPACE
Suture Techniques
Cosmesis
medicine.disease
PREVENTION
Mastectomy/methods
Surgery
Axilla
Seroma
Seroma aspiration
Quality of Life
Cost-effectiveness
business
Zdroj: BMC Cancer, Vol 18, Iss 1, Pp 1-8 (2018)
BMC Cancer
BMC Cancer, 18:830. BioMed Central Ltd
ISSN: 1471-2407
DOI: 10.1186/s12885-018-4740-8
Popis: 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. 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. This 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). This 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. This 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 .
Databáze: OpenAIRE
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