Is dangling of the lower leg after a free flap reconstruction necessary? Study protocol for a large multicenter randomized controlled study

Trials

Marc A. M. Mureau¹  Antonius J. M. Luijsterburg¹  Eva S. J. van der Beek²  Tallechien M. T. Tempelman²  Wiesje Maarse³  J. Henk Coert³  David D. Krijgh³  Teun Teunis³  Pascal P. A. Schellekens³ 

[1] Department of Plastic and Reconstructive Surgery, Erasmus MC, University Medical Center Rotterdam;Department of Plastic and Reconstructive Surgery, University Medical Center Groningen;Department of Plastic and Reconstructive Surgery, University Medical Center Utrecht;

关键词: Free flap;    Lower leg;    Dangling;    Complications;    Physical function;    Infection;   

DOI  :  10.1186/s13063-019-3665-0

来源: DOAJ

【 摘 要 】

Abstract Background Within the field of plastic surgery, free tissue transfer is common practice for knee and lower leg defects. Usually, after such free flap reconstruction, patients undergo a dangling protocol in the postoperative phase. A dangling protocol is designed to gradually subject the free flap to increased venous pressure resulting from gravitational forces. Worldwide there are multiple variations of dangling protocols. However, there is no evidence available in the literature that supports the use of a dangling protocol. Methods This is a multicenter randomized controlled trial that includes patients with a free flap lower leg reconstruction. The primary outcome is to assess whether a no-dangling protocol is not inferior to a dangling protocol, in terms of proportion of partial flap loss, 6 months after surgery. Secondary objectives are to identify differences in major and minor complications, length of stay, and costs, and to objectify blood gaseous changes during dangling. Furthermore, at 2 years we will assess difference in physical function, infection rates, and osseous union rates. Discussion The primary outcome of this study will give a more decisive answer to the question of whether a dangling protocol is necessary after a free flap reconstruction of the lower leg. The secondary outcomes of this study will provide a better insight into the physical functions, infection rates, and union rates in these patients. Trial registration Central Committee on Research Involving Human Subjects (CCMO), NL63146.041.17. Registered on 11 July 2018. Netherlands Trial Register, NTR7545. Registered on 10 October 2018.

【 授权许可】

Unknown