Abstract
Background: Surgical adhesive drapes can be used to create an aseptic area around the operative wound to reduce bacterial infection. However, the efficacy of such drapes in preventing wound infection remains unclear. Few studies have examined the effects of iodophor-impregnated and iodophor-free adhesive drapes on bacteria in the deeper layers of the epidermis. We therefore plan to compare the effects of 3M iodophor-impregnated antibacterial adhesive drapes and 3M aseptic iodophor-free adhesive drapes on the incidence of wound infection and wound healing after total hip arthroplasty. Methods/Design: We will perform a single-center, randomized, double-blinded, parallel-cohort controlled trial at the Hospital of Bone Injury, Guangzhou University of Traditional Chinese Medicine, China. A total of 120 patients scheduled for total hip arthroplasty will be numbered according to their sequence of admission to the operating room and sex, in a single-blinded manner: men, nos. 1-60 and women, nos. 1-60. Odd-numbered patients will be operated on using iodophor-impregnated adhesive drapes, and even-numbered with iodophor-free adhesive drapes at the surgical site. Peri-articular tissue will be harvested for bacterial culture after disinfection and again between the end of surgery and prior to skin suturing. The primary outcomes will be Bacterial culture results, wound healing time and grade, The secondary outcomes will be pain score (Visual Analog Scale), Harris score, and X-ray results. Discussion: The trial outcomes will support the rational use of iodophor-impregnated surgical adhesive drapes for preventing wound infections after total hip arthroplasty. Trial registration: ClinicalTrial.gov identifier: NCT02707302. Ethical approval: This study protocol acquired written approval from Ethics Committee of Hospital of Bone Injury, Guangzhou University of Traditional Chinese Medicine, China (approval No. 2016-001-01), and will be performed in accordance with the Declaration of Helsinki developed by the World Medical Association.
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