Sutures Versus Staples for Wound Closure in Orthopaedic Surgery

Sutures vs Staples for Wound Closure in Orthopaedic Surgery: A Randomized Controlled Trial

The trial is a randomized, controlled trial. Adult patients undergoing orthopaedic surgical procedures would be randomized to one of two groups for surgical wound closure, skin sutures or skin staples. The primary outcome measures would be surgical site infection indicated by the use of oral or intravenous antibiotics for suspected wound infection and/or re-operation at the same site. Patients would be followed up as per their usual post-operative course for a total of three months in the trauma and spine population and six months in the total joint arthroplasty population. It is hypothesized that wounds closed with sutures and staples will have similar infection rates as defined by the use of antibiotics or reoperation.

Study Overview

• Status: Completed
• Conditions: Surgical Wound Infection
• Intervention / Treatment: Device: Sutures; Device: Staples

Detailed Description

To date, there is no clear consensus on the method that is best for closure of surgical wounds in orthopaedic surgery. Orthopaedic surgeons have a multitude of wound closure habits. A recent meta-analysis comparing staples to sutures in wound closure demonstrated a three-fold increase in infection in stapled wounds compared to sutured wounds. The studies used in the meta-analysis were primarily of poor methodological quality.

A large, well-designed randomized, controlled trial is needed to guide orthopedic surgeons in their choice of wound closure materials. This study would attempt to provide information on the use of sutures versus skin staples and the effect on the development of surgical site infections in adults undergoing orthopaedic procedures.

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 of participants and outcome assessors. The primary outcome measure will be infections adjudicated by a blinded data safety monitoring committee. Suspected infections will be defined by: Use of antibiotics or reoperation for infection at the operative site within three months (six months for arthroplasty subgroup) The independent review, board blinded to treatment assignment, will adjudicate suspected infections based on clinical data. A cost analysis will also be performed to compare the costs associated with wounds closed with sutures and staples from a health care institution perspective.

All data will be analyzed by a blinded epidemiologist. Dichotomous primary and secondary outcome measures will be analyzed using the Chi-squared statistic. Continuous outcome measures will be analyzed using Student's t-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 patients. Non-infected revision surgery will also be compared to primary surgery.

It is hypothesized that wounds closed with sutures and staples will have similar infection rates as defined by the use of antibiotics or reoperation.

• Study Type: Interventional
• Enrollment (Actual): 247
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3E4
      • Pan Am Clinic
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Health Sciences Centre
    • Winnipeg, Manitoba, Canada, R2K 2M9
      • Concordia Hip and Knee Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients (>18 years old)
• All open orthopedic procedures
• Largest wound >2cm in length

Exclusion Criteria:

• Open fracture
• Known nickel allergy
• Active infection (any site)
• Chemotherapy during study period (1 month prior until end of follow-up)
• Radiation therapy to surgical site (1 month prior until end of follow-up)
• Foot surgery (any site)
• Hand surgery (including carpal surgery)
• Arthroscopic procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sutures; Orthopedic surgical wound closed with sutures	Device: Sutures; Orthopedic surgical wounds closed with sutures
Active Comparator: Staples; Orthopedic surgical wound closed with metallic staples	Device: Staples; Orthopedic surgical wounds closed with metallic staples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site infection	Suspected cases will be identified by one or all of the following: use of intravenous antibiotics, use of oral antibiotics (patient self-reported), re-operation at same site. A blinded committee will adjudicate each suspected case and determine true infections using available clinical information. Agreement will be determined by vote.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional healthcare contact related to their surgery	As defined by self-reported visits to other healthcare professionals.	6 months
Dressing changes by homecare/patient at home	Defined by homecare consult records and patient self-report	6 months
Length of stay	Based on admission and discharge dates	6 months
Wound drainage	As defined by necessity for dressing changes after 72 hours for fluid leakage	6 months
Wound necrosis	Evidence of marginal skin death at the surgical site as evidenced by skin slough, blackening or liquefaction	6 months
Patient satisfaction with wound appearance	Using visual analogue scale	6 months
Visual analogue pain score for suture/staple removal	Patients will rate the pain experienced in removing the wound closure materials in clinic prior to unblinding.	2 weeks post-operative

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Manitoba Medical Service Foundation; Gibson Orthopaedic Fund for Research and Education
• Investigators: Principal Investigator: Jesse Shantz, MD, MBA, University of Manitoba

Publications and helpful links

General Publications

• Slade Shantz JA, Vernon J, Morshed S, Leiter J, Stranges G. Sutures versus staples for wound closure in orthopaedic surgery: a pilot randomized controlled trial. Patient Saf Surg. 2013 Feb 9;7(1):6. doi: 10.1186/1754-9493-7-6.
• Shantz JA, Vernon J, Leiter J, Morshed S, Stranges G. Sutures versus staples for wound closure in orthopaedic surgery: a randomized controlled trial. BMC Musculoskelet Disord. 2012 Jun 6;13:89. doi: 10.1186/1471-2474-13-89.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: June 14, 2010
• First Submitted That Met QC Criteria: June 16, 2010
• First Posted (Estimate): June 17, 2010

Study Record Updates

• Last Update Posted (Actual): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 12, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Infection; Post-operative; Sutures; Surgical; Staples
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wounds and Injuries; Surgical Wound; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: WCRCT