Sutures Versus Staples for Wound Closure in Orthopaedic Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Manitoba.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Manitoba Institute for Patient Safety
Manitoba Medical Service Foundation
Alexander Gibson Fund
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01146236
First received: June 14, 2010
Last updated: April 4, 2011
Last verified: April 2011
  Purpose

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 Intervention
Surgical Wound Infection
Device: Sutures
Device: Staples

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Sutures vs Staples for Wound Closure in Orthopaedic Surgery: A Randomized Controlled Trial

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Surgical site infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Additional healthcare contact related to their surgery [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    As defined by self-reported visits to other healthcare professionals.

  • Dressing changes by homecare/patient at home [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Defined by homecare consult records and patient self-report

  • Length of stay [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Based on admission and discharge dates

  • Wound drainage [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    As defined by necessity for dressing changes after 72 hours for fluid leakage

  • Wound necrosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evidence of marginal skin death at the surgical site as evidenced by skin slough, blackening or liquefaction

  • Patient satisfaction with wound appearance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Using visual analogue scale

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


Estimated Enrollment: 2560
Study Start Date: July 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01146236

Contacts
Contact: Jesse Shantz, MD, MBA +1-204-996-0595 jshantz2@gmail.com
Contact: James Vernon, MBBS, MSc +1-204-295-9735 jamesvernon23@yahoo.com

Locations
Canada, Manitoba
Health Sciences Centre Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: Jesse A Shantz, MD MBA    (204)996-0595    jshantz2@gmail.com   
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       leila200x@yahoo.com   
Contact: Jeff Leiter, PhD       jleiter@panamclinic.com   
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         
Concordia Hip and Knee Institute Recruiting
Winnipeg, Manitoba, Canada, R2K 2M9
Contact: Sarah Tran       stran@cjrg.ca   
Sub-Investigator: Eric Bohm, MD         
Sub-Investigator: Thomas Turgeon, MD MPH         
Sub-Investigator: Colin Burnell, MD         
Sub-Investigator: David R Hedden, MD         
Sponsors and Collaborators
University of Manitoba
Manitoba Institute for Patient Safety
Manitoba Medical Service Foundation
Alexander Gibson Fund
Investigators
Principal Investigator: Jesse Shantz, MD, MBA University of Manitoba
  More Information

No publications provided by University of Manitoba

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Greg Stranges, Orthopedic Surgeon, Department of Surgery, University of Manitoba
ClinicalTrials.gov Identifier: NCT01146236     History of Changes
Other Study ID Numbers: WCRCT
Study First Received: June 14, 2010
Last Updated: April 4, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
Surgical
Infection
Post-operative
Sutures
Staples

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

ClinicalTrials.gov processed this record on April 17, 2014