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Open Access Study protocol

Sutures versus staples for wound closure in orthopaedic surgery: a randomized controlled trial

Jesse A Shantz12*, James Vernon13, Jeff Leiter14, Saam Morshed2 and Gregory Stranges14

Author Affiliations

1 Pan Am Clinic, 75 Poseidon Bay, Winnipeg, MB, R3M 3E4, Canada

2 Orthopaedic Trauma Institute at San Francisco General Hospital, University of California, San Francisco, 2550 23rd Street, Building 9, 2nd Floor, San Francisco, CA, 94110, USA

3 Section of Orthopaedics, Dunedin School of Medicine, PO Box 913, Dunedin, New Zealand

4 Section of Orthopaedic Surgery, University of Manitoba, AD-401, 820 Sherbrook St., Winnipeg, MB, R3A 1R9, Canada

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BMC Musculoskeletal Disorders 2012, 13:89  doi:10.1186/1471-2474-13-89

Published: 6 June 2012

Abstract

Background

A recently published meta-analysis comparing metallic staples to sutures in orthopaedic procedures revealed three fold increase in risk for infection in stapled wounds. The studies included in the meta-analysis are at risk of bias due to experimental design limitations. A large randomized controlled trial is proposed to direct orthopaedic surgeons in their choice of wound closure material.

Methods/Design

A parallel group randomized controlled trial with institutional review board approval will be conducted. Patients will be randomized intraoperatively to have skin wounds closed with sutures or staples. Dressings will be used to maintain blinding outcome assessors. The primary outcome measure will be a composite all-cause wound complication outcome measure composed of: infection, wound drainage, wound necrosis, blistering, dehiscence, suture abscess and material sensitivity reaction. An independent review board blinded to treatment assignment will adjudicate suspected complications based on clinical data. All deceased patients will also be reviewed. An interim analysis of complications will take place after half of the patients have been recruited. All data will be analyzed by a blinded statistician. Dichotomous primary and secondary outcome measures will be analyzed using the Chi-squared statistic. Continuous outcome measures will be analyzed using Student's‚ÄČt-test. Subgroup analysis will compare infection rates using sutures versus staples in each anatomic area (upper extremity, pelvis/acetabulum, hip/femur, knee, ankle). A further subgroup analysis will be conducted comparing trauma patients to elective surgery patients. Non-infected revision surgery will also be compared to primary surgery.

Discussion

Wound closure material is an afterthought for many orthopaedic surgeons. The combined results of several comparative trials suggests that the choice of wound closure materials may have an impact on the rate of surgical site infections. However, the strength of the evidence is poor given the heterogeneity of the methods employed in previous studies. The following study protocol aims to guide surgeons in their choice of wound closure material by determining if there is a difference in complication rates in sutured and stapled wounds.

Trial Registration

This trial was registered at ClinicalTrials.gov under the identifier NCT01146236 (registered June 14, 2010)

Keywords:
Wound closure; Orthopaedic surgery; Sutures; Staples; Surgical wound complications; Surgical site infection