Department of surgery, Zuyderland Medical Center, Sittard-Geleen, the Netherlands.
Department of Surgery, Netherlands Cancer Institute, Amsterdam, the Netherlands.
BMC Cancer. 2018 Aug 17;18(1):830. doi: 10.1186/s12885-018-4740-8.
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 .
血清肿的形成是乳房切除术后的常见并发症，与伤口愈合延迟、感染、皮瓣坏死、患者不适以及反复到门诊处理血清肿及其后遗症有关。乳房切除术后关闭死腔似乎是减少血清肿及其并发症的关键。已经描述了各种方法来减少乳房切除术后的死腔：闭式负压引流、皮瓣缝合和应用组织胶。本试验旨在比较各种皮瓣固定方法对血清肿形成及其后遗症的影响。
这是一项多中心、双盲、随机对照试验，纳入行乳房切除术（包括或不包括腋窝清扫术）的女性乳腺癌患者。排除标准包括保乳治疗、直接乳房重建以及无法理解研究的意义和范围，并且无法签署知情同意书。共纳入 336 例患者，将随机分为三组，分别采用 ARTISS 组织胶联合低负压引流固定皮瓣、缝线联合低负压引流固定皮瓣或常规缝合关闭（不固定皮瓣）联合低负压引流。术后随访 12 个月。主要结局为血清肿抽吸次数，次要结局包括门诊就诊次数、手术部位皮肤感染率、肩关节功能、美容效果、健康相关生活质量和成本及成本效益（成本/QALY）。
这是第一项评估皮瓣固定及其后遗症（即血清肿抽吸次数、门诊就诊次数、感染、肩关节功能、患者评估美容效果、生活质量和成本效益）的随机双盲对照试验。
本试验经医院联合医学伦理委员会批准（14-T-21，2014 年 6 月 2 日）。SAM 试验于 2017 年 10 月在 ClinicalTrials.gov 注册，标识符：NCT03305757。
