Effect of Triclosan-Coated Suture and Antibiotic Prophylaxis on Infection and Recurrence after Karydakis Flap Repair for Pilonidal Disease: A Randomized Parallel-Arm Double-Blinded Clinical Trial

Abstract Background: Pilonidal sinus disease was first described by Mayo in 1833 as “a cyst that contains hair.” Although surgical treatment of the lesions can have successful outcomes, it also can be associated with relatively high rates of post-operative infectioins and recurrence. Many studies have demonstrated that triclosan-coated sutures (TCS) decrease surgical site infections. Objective: The goal of this randomized parallel-arm double-blind clinical trial was to investigate the ability of antibiotic prophylaxis, and secondarily of antibiotic-coated sutures, to prevent post-operative infections in the surgical management of pilonidal sinus disease. Patients and Methods: The initial trial protocol aimed to compare early infections in patients who did and did not undergo antibiotic prophylaxis (AP+ vs. AP-). A secondary goal was to compare the effects of TCS and conventional sutures (CS) on early infectious complication rates in the two groups. The AP- arm had to be terminated prematurely because of a...