Sutures Versus Staples for Wound Closure in Orthopaedic Surgery

October 12, 2018 updated by: Dr. Jesse Shantz, University of Manitoba

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
247

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3E4
        • Pan Am Clinic
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Health Sciences Centre
      • Winnipeg, Manitoba, Canada, R2K 2M9
        • Concordia Hip and Knee Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Sutures
Orthopedic surgical wound closed with sutures
Device: Sutures
Orthopedic surgical wounds closed with sutures
Active Comparator: Staples
Orthopedic surgical wound closed with metallic staples
Device: Staples
Orthopedic surgical wounds closed with metallic staples

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Surgical site infection
Time Frame: 6 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Additional healthcare contact related to their surgery
Time Frame: 6 months
As defined by self-reported visits to other healthcare professionals.
6 months
Dressing changes by homecare/patient at home
Time Frame: 6 months
Defined by homecare consult records and patient self-report
6 months
Length of stay
Time Frame: 6 months
Based on admission and discharge dates
6 months
Wound drainage
Time Frame: 6 months
As defined by necessity for dressing changes after 72 hours for fluid leakage
6 months
Wound necrosis
Time Frame: 6 months
Evidence of marginal skin death at the surgical site as evidenced by skin slough, blackening or liquefaction
6 months
Patient satisfaction with wound appearance
Time Frame: 6 months
Using visual analogue scale
6 months
Visual analogue pain score for suture/staple removal
Time Frame: 2 weeks post-operative
Patients will rate the pain experienced in removing the wound closure materials in clinic prior to unblinding.
2 weeks post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Manitoba Medical Service Foundation
Gibson Orthopaedic Fund for Research and Education

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jesse Shantz, MD, MBA, University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WCRCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings