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

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, six months after surgery. Secondary objectives are to identify differences in major and minor complications, length of stay, 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 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: Registered at the CCMO (Dutch Medical Research Ethics Commission) in the Netherlands on 11 July 2018: NL63146.041.17. Registered with the Dutch Trial Register (registration number NTR 7545).