Clinical trial NCT01146236: Sutures Versus Staples for Wound Closure in Orthopaedic Surgery
Official title: Sutures vs Staples for Wound Closure in Orthopaedic Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Infection
Keywords: Surgical
Infection
Post-operative
Sutures
Staples
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Manitoba Medical Service Foundation
name: Gibson Orthopaedic Fund for Research and Education
First posted: 2010-06-17
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Surgical site infection
timeFrame: 6 months
Secondary outcomes:
measure: Additional healthcare contact related to their surgery
timeFrame: 6 months
measure: Dressing changes by homecare/patient at home
timeFrame: 6 months
measure: Length of stay
timeFrame: 6 months
measure: Wound drainage
timeFrame: 6 months
measure: Wound necrosis
timeFrame: 6 months
measure: Patient satisfaction with wound appearance
timeFrame: 6 months
measure: Visual analogue pain score for suture/staple removal
timeFrame: 2 weeks post-operative
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Concordia Hip and Knee Institute
state: Manitoba
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Winnipeg
country: Canada
facility: Pan Am Clinic
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Jesse Shantz, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.