Sutures Versus Staples for Wound Closure in Orthopaedic Surgery

Surgical Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146236
• Other study ID #: WCRCT
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Est. completion date: December 2013

Study information

• Verified date: October 2018
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Wound
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

Device:
• Sutures
Orthopedic surgical wounds closed with sutures
• Staples
Orthopedic surgical wounds closed with metallic staples

Locations

Country	Name	City	State
Canada	Concordia Hip and Knee Institute	Winnipeg	Manitoba
Canada	Health Sciences Centre	Winnipeg	Manitoba
Canada	Pan Am Clinic	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
University of Manitoba	Gibson Orthopaedic Fund for Research and Education, Manitoba Medical Service Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Additional healthcare contact related to their surgery	As defined by self-reported visits to other healthcare professionals.	6 months
Secondary	Dressing changes by homecare/patient at home	Defined by homecare consult records and patient self-report	6 months
Secondary	Length of stay	Based on admission and discharge dates	6 months
Secondary	Wound drainage	As defined by necessity for dressing changes after 72 hours for fluid leakage	6 months
Secondary	Wound necrosis	Evidence of marginal skin death at the surgical site as evidenced by skin slough, blackening or liquefaction	6 months
Secondary	Patient satisfaction with wound appearance	Using visual analogue scale	6 months
Secondary	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