Sutures Versus Staples for Wound Closure in Orthopaedic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01146236
Recruitment Status : Unknown
Verified April 2011 by University of Manitoba.
Recruitment status was:  Recruiting
First Posted : June 17, 2010
Last Update Posted : April 5, 2011
Manitoba Institute for Patient Safety
Manitoba Medical Service Foundation
Gibson Orthopaedic Fund for Research and Education
Information provided by:
University of Manitoba

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Surgical Wound Infection Device: Sutures Device: Staples Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 2560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Sutures vs Staples for Wound Closure in Orthopaedic Surgery: A Randomized Controlled Trial
Study Start Date : July 2010
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Surgical site infection [ Time Frame: 6 months ]
    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.

Secondary Outcome Measures :
  1. Additional healthcare contact related to their surgery [ Time Frame: 6 months ]
    As defined by self-reported visits to other healthcare professionals.

  2. Dressing changes by homecare/patient at home [ Time Frame: 6 months ]
    Defined by homecare consult records and patient self-report

  3. Length of stay [ Time Frame: 6 months ]
    Based on admission and discharge dates

  4. Wound drainage [ Time Frame: 6 months ]
    As defined by necessity for dressing changes after 72 hours for fluid leakage

  5. Wound necrosis [ Time Frame: 6 months ]
    Evidence of marginal skin death at the surgical site as evidenced by skin slough, blackening or liquefaction

  6. Patient satisfaction with wound appearance [ Time Frame: 6 months ]
    Using visual analogue scale

  7. Visual analogue pain score for suture/staple removal [ Time Frame: 2 weeks post-operative ]
    Patients will rate the pain experienced in removing the wound closure materials in clinic prior to unblinding.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01146236

Contact: Jesse Shantz, MD, MBA +1-204-996-0595
Contact: James Vernon, MBBS, MSc +1-204-295-9735

Canada, Manitoba
Concordia Hip and Knee Institute Recruiting
Winnipeg, Manitoba, Canada, R2K 2M9
Contact: Sarah Tran   
Sub-Investigator: Eric Bohm, MD         
Sub-Investigator: Thomas Turgeon, MD MPH         
Sub-Investigator: Colin Burnell, MD         
Sub-Investigator: David R Hedden, MD         
Health Sciences Centre Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: Jesse A Shantz, MD MBA    (204)996-0595   
Sub-Investigator: Laurie W Barron, MD         
Sub-Investigator: Ted V Tufescu, MD         
Sub-Investigator: Christopher P Graham, MD         
Sub-Investigator: Allan Hammond, MD         
Sub-Investigator: Bradley D Pilkey, MD         
Pan Am Clinic Recruiting
Winnipeg, Manitoba, Canada, R3M 3E4
Contact: Leilanie Clayton, MSc   
Contact: Jeff Leiter, PhD   
Principal Investigator: Greg Stranges, MD         
Sub-Investigator: Peter B MacDonald, MD         
Sub-Investigator: Jason A Old, MD         
Sub-Investigator: Tod Clark, MD MSc         
Sub-Investigator: James H Dubberley, MD         
Sponsors and Collaborators
University of Manitoba
Manitoba Institute for Patient Safety
Manitoba Medical Service Foundation
Gibson Orthopaedic Fund for Research and Education
Principal Investigator: Jesse Shantz, MD, MBA University of Manitoba

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Greg Stranges, Orthopedic Surgeon, Department of Surgery, University of Manitoba Identifier: NCT01146236     History of Changes
Other Study ID Numbers: WCRCT
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: April 5, 2011
Last Verified: April 2011

Keywords provided by University of Manitoba:

Additional relevant MeSH terms:
Wounds and Injuries
Wound Infection
Surgical Wound
Surgical Wound Infection
Postoperative Complications
Pathologic Processes