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Sutures Versus Staples for Wound Closure in Orthopaedic Surgery

NCT01146236 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2018-10-17

No results posted yet for this study

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.

Conditions

  • Surgical Wound Infection

Interventions

DEVICE

Sutures

Orthopedic surgical wounds closed with sutures

DEVICE

Staples

Orthopedic surgical wounds closed with metallic staples

Sponsors & Collaborators

  • Manitoba Medical Service Foundation

    collaborator OTHER

  • Gibson Orthopaedic Fund for Research and Education

    collaborator OTHER

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Jesse Shantz, MD, MBA · University of Manitoba

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-09-30
Completion
2013-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01146236 on ClinicalTrials.gov