NCT01146236

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
247

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

3.2 years

First QC Date

June 14, 2010

Last Update Submit

October 12, 2018

Conditions

Surgical Wound Infection

Keywords

SurgicalInfectionPost-operativeSuturesStaples

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Additional healthcare contact related to their surgery

    6 months

  • Dressing changes by homecare/patient at home

    6 months

  • Length of stay

    6 months

  • Wound drainage

    6 months

  • Wound necrosis

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Sutures

ACTIVE COMPARATOR

Orthopedic surgical wound closed with sutures

Device: Sutures

Staples

ACTIVE COMPARATOR

Orthopedic surgical wound closed with metallic staples

Device: Staples

Interventions

SuturesDEVICE

Orthopedic surgical wounds closed with sutures

Sutures
StaplesDEVICE

Orthopedic surgical wounds closed with metallic staples

Staples

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (\>18 years old)
  • All open orthopedic procedures
  • Largest wound \>2cm in length

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Concordia Hip and Knee Institute

Winnipeg, Manitoba, R2K 2M9, Canada

Location

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

Location

Related Publications (2)

  • 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.

    PMID: 23394586DERIVED

  • 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.

    PMID: 22672186DERIVED

MeSH Terms

Conditions

Surgical Wound InfectionInfections

Interventions

Sutures

Condition Hierarchy (Ancestors)

Wound InfectionPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Jesse Shantz, MD, MBA

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic Surgeon

Study Record Dates

First Submitted

June 14, 2010

First Posted

June 17, 2010

Study Start

July 1, 2010

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

October 17, 2018

Record last verified: 2018-10

Locations

CA(3)