An interventional study of Sutures and Staples in Surgical Wound Infection, sponsored by University of Manitoba. Completed at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-17.
Sponsored by University of Manitoba · Not applicable, Interventional, and Prevention
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.
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.
382 studies on the registry are indexed under Wound Infection; 40 are open to participants now.
This study's enrollment of 247 is above the median of 150 across 296 interventional studies indexed under Wound Infection.
Browse Wound Infection studies →University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Orthopedic surgical wound closed with sutures
Device: Sutures
Orthopedic surgical wound closed with metallic staples
Device: Staples
Orthopedic surgical wounds closed with sutures
Orthopedic surgical wounds closed with metallic staples
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.
Time frame: 6 months
Additional healthcare contact related to their surgery
As defined by self-reported visits to other healthcare professionals.
Time frame: 6 months
Dressing changes by homecare/patient at home
Defined by homecare consult records and patient self-report
Time frame: 6 months
Length of stay
Based on admission and discharge dates
Time frame: 6 months
Wound drainage
As defined by necessity for dressing changes after 72 hours for fluid leakage
Time frame: 6 months
Wound necrosis
Evidence of marginal skin death at the surgical site as evidenced by skin slough, blackening or liquefaction
Time frame: 6 months
Patient satisfaction with wound appearance
Using visual analogue scale
Time frame: 6 months
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.
Time frame: 2 weeks post-operative
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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University of Manitoba