Primary or secondary wound healing of the pin sites after removal of the external fixator: study protocol for a prospective, randomized controlled, monocenter trial

This study compares primary wound closure with secondary wound healing for the pin site. The primary aim is to compare pin-site infection rates. The secondary aim is to compare time to wound healing and esthetic outcome. The hypothesis was that primary wound closure does not lead to more infections than secondary wound healing.Methods and designThis is a prospective, randomized controlled, blinded, monocenter study based on a non-inferiority design. To obtain an equal patient population and groups, all pin-entry sites of the patients are treated alternately at the time of removal of the external fixator with primary wound closure and secondary wound healing. Patients are randomized according to whether the proximal pin-entry site is treated with wound closure or by secondary open-wound healing, from which the further sequence develops. The pre- and postoperative protocol is standardized for all pin-entry sites. A photo documentation of the pin-entry sites takes place 2 and 52  weeks postoperatively during the routine clinical follow-up visits. Further controls take place at 6, 12 and 26 weeks after pin removal.The primary outcome was to demonstrate the non-inferiority of primary wound closure compared to secondary wound healing in terms of postoperative wound infections according to the Center of Disease Control and Prevention (CDC) definitions.The secondary outcomes are time to complete wound healing (days) and esthetical outcome (subjective preference of patients and Va...

Source: Trials - February 18, 2020 Category: Research Source Type: clinical trials