Sutures Versus Staples for Wound Closure in Orthopaedic Surgery

NCT ID: NCT01146236

Last Updated: 2018-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 247 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-12-31

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.

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.

Conditions

Surgical Wound Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Sutures

Orthopedic surgical wound closed with sutures

Group Type: ACTIVE_COMPARATOR

Sutures

Intervention Type: DEVICE

Orthopedic surgical wounds closed with sutures

Staples

Orthopedic surgical wound closed with metallic staples

Group Type: ACTIVE_COMPARATOR

Staples

Intervention Type: DEVICE

Orthopedic surgical wounds closed with metallic staples

Interventions

Sutures

Orthopedic surgical wounds closed with sutures

Intervention Type: DEVICE

Staples

Orthopedic surgical wounds closed with metallic staples

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manitoba Medical Service Foundation

OTHER

Sponsor Role: collaborator

Gibson Orthopaedic Fund for Research and Education

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Dr. Jesse Shantz

Orthopedic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jesse Shantz, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Concordia Hip and Knee Institute

Winnipeg, Manitoba, Canada

Health Sciences Centre

Winnipeg, Manitoba, Canada

Pan Am Clinic

Winnipeg, Manitoba, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 23394586 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22672186 (View on PubMed)

Other Identifiers

WCRCT

Identifier Type: -

Identifier Source: org_study_id