PDF(Pubmed)
Abstract：
UNASSIGNED: A common complication after a DIEP flap reconstruction is the occurrence of fat necrosis due to inadequate flap perfusion zones. Intraoperative identification of ischemic zones in the DIEP flap could be optimized using indocyanine green near-infrared fluorescence angiography (ICG-NIR-FA). This randomized controlled trial aims to determine whether intraoperative ICG-NIR-FA for the assessment of DIEP flap perfusion decreases the occurrence of fat necrosis.
UNASSIGNED: This article describes the protocol of a Dutch multicenter randomized controlled clinical trial: the FAFI-trial. Females who are electively scheduled for autologous breast reconstruction using DIEP or muscle-sparing transverse rectus abdominis muscle (msTRAM) flaps are included. A total of 280 patients will be included in a 1:1 ratio between both study arms. In the intervention arm, the intraoperative assessment of flap perfusion will be based on both regular clinical parameters and ICG-NIR-FA. The control arm consists of flap perfusion evaluation only through the regular clinical parameters, while ICG-NIR-FA images are obtained during surgery for which the surgeon is blinded. The main study endpoint is the difference in percentage of clinically relevant fat necrosis between both study arms, evaluated two weeks and three months after reconstruction.
UNASSIGNED: The FAFI-trial, a Dutch multicenter randomized controlled clinical trial, aims to investigate the clinical added value of intraoperative use of standardized ICG-NIR-FA for assessment of DIEP/msTRAM flap perfusion in the reduction of fat necrosis.
UNASSIGNED: NCT05507710; NL 68623.058.18.
UNASSIGNED: This article describes the protocol of a Dutch multicenter randomized controlled clinical trial: the FAFI-trial. Females who are electively scheduled for autologous breast reconstruction using DIEP or muscle-sparing transverse rectus abdominis muscle (msTRAM) flaps are included. A total of 280 patients will be included in a 1:1 ratio between both study arms. In the intervention arm, the intraoperative assessment of flap perfusion will be based on both regular clinical parameters and ICG-NIR-FA. The control arm consists of flap perfusion evaluation only through the regular clinical parameters, while ICG-NIR-FA images are obtained during surgery for which the surgeon is blinded. The main study endpoint is the difference in percentage of clinically relevant fat necrosis between both study arms, evaluated two weeks and three months after reconstruction.
UNASSIGNED: The FAFI-trial, a Dutch multicenter randomized controlled clinical trial, aims to investigate the clinical added value of intraoperative use of standardized ICG-NIR-FA for assessment of DIEP/msTRAM flap perfusion in the reduction of fat necrosis.
UNASSIGNED: NCT05507710; NL 68623.058.18.
摘要：
■DIEP皮瓣重建后的常见并发症是由于皮瓣灌注区不足而发生脂肪坏死。可以使用吲哚菁绿近红外荧光血管造影（ICG-NIR-FA）优化DIEP皮瓣中缺血区的术中识别。这项随机对照试验旨在确定术中ICG-NIR-FA是否用于评估DIEP皮瓣灌注减少脂肪坏死的发生。
■本文描述了荷兰多中心随机对照临床试验的方案：FAFI试验。包括选择使用DIEP或保留肌肉的腹直肌横肌（msTRAM）皮瓣进行自体乳房重建的女性。总共280名患者将在两个研究组之间以1:1的比例包括在内。在干预臂中，术中皮瓣灌注评估将基于常规临床参数和ICG-NIR-FA.控制臂仅通过常规临床参数进行皮瓣灌注评估，而ICG-NIR-FA图像是在外科医生失明的手术期间获得的。主要研究终点是两个研究组之间临床相关脂肪坏死百分比的差异，重建后两周和三个月评估。
■FAFI试验，荷兰一项多中心随机对照临床试验，目的探讨术中使用标准化ICG-NIR-FA评估DIEP/msTRAM皮瓣灌注减少脂肪坏死的临床附加值。
■NCT05507710；NL68623.058.18。
■本文描述了荷兰多中心随机对照临床试验的方案：FAFI试验。包括选择使用DIEP或保留肌肉的腹直肌横肌（msTRAM）皮瓣进行自体乳房重建的女性。总共280名患者将在两个研究组之间以1:1的比例包括在内。在干预臂中，术中皮瓣灌注评估将基于常规临床参数和ICG-NIR-FA.控制臂仅通过常规临床参数进行皮瓣灌注评估，而ICG-NIR-FA图像是在外科医生失明的手术期间获得的。主要研究终点是两个研究组之间临床相关脂肪坏死百分比的差异，重建后两周和三个月评估。
■FAFI试验，荷兰一项多中心随机对照临床试验，目的探讨术中使用标准化ICG-NIR-FA评估DIEP/msTRAM皮瓣灌注减少脂肪坏死的临床附加值。
■NCT05507710；NL68623.058.18。
