Back to resultsA Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures
Primary Purpose
Type II and IIa Open Tibia Fractures
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
delayed closure
immediate wound closure
Sponsored by
About this trial
This is an interventional treatment trial for Type II and IIa Open Tibia Fractures
Eligibility Criteria
Inclusion Criteria:
- Gustilo type II-IIIa tibia fracture
- age greater than 15 years
- fractures amenable to intramedullary nailing
Exclusion Criteria:
- excessive wound contamination
- patient cardio-pulmonary or hemodynamic instability preventing prompt surgical intervention
- impaired or absent consciousness
- refusal of consent
Sites / Locations
- Carolinas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
delayed closure
immediate wound closure
Arm Description
wounds packed open with normal saline wet to dry gauze dressings and were returned to the operating room 36 to 72 hours after initial procedure for debridement and definitive closure.
traumatic and surgical wounds closed at initial surgical intervention
Outcomes
Primary Outcome Measures
infection rate
defined as cases determined definitively by a positive culture or treated empirically based on tenderness, erythema, and heat at the wound site.
hospital readmissions
need for additional procedures and hospital readmissions related to the index injury will be documented
tibial fracture healing
evidence of bridging callus on three of four cortices assessed by biplanar radiograph
Secondary Outcome Measures
Full Information
NCT ID
NCT01315392
First Posted
March 1, 2011
Last Updated
April 19, 2022
Sponsor
Wake Forest University Health Sciences
Collaborators
Orthopaedic Trauma Association, Orthopaedic Research and Education Fund
1. Study Identification
Unique Protocol Identification Number
NCT01315392
Brief Title
A Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures
Official Title
A Randomized Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Orthopaedic Trauma Association, Orthopaedic Research and Education Fund
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Delayed wound closure is considered by many to be the standard of care for the treatment of an open fracture. This study was conducted to determine the feasibility of a large multi-center prospective randomized clinical trial and collect the pilot data needed to compete for the funding for such a trial. The study was designed to compare immediate and delayed closure of Gustilo type II and IIIa tibia diaphyseal fractures. The primary outcomes were the infection rates and fracture related complications in patients treated with immediate or delayed wound closure strategies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II and IIa Open Tibia Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Enrollment
451 (Actual)
8. Arms, Groups, and Interventions
Arm Title
delayed closure
Arm Type
Active Comparator
Arm Description
wounds packed open with normal saline wet to dry gauze dressings and were returned to the operating room 36 to 72 hours after initial procedure for debridement and definitive closure.
Arm Title
immediate wound closure
Arm Type
Active Comparator
Arm Description
traumatic and surgical wounds closed at initial surgical intervention
Intervention Type
Procedure
Intervention Name(s)
delayed closure
Intervention Description
wounds packed open with normal saline wet to dry gauze dressings and were returned to the operating room 36 to 72 hours after initial procedure for a second debridement and definitive closure.
Intervention Type
Procedure
Intervention Name(s)
immediate wound closure
Intervention Description
traumatic and surgical wounds closed at the initial surgical intervention
Primary Outcome Measure Information:
Title
infection rate
Description
defined as cases determined definitively by a positive culture or treated empirically based on tenderness, erythema, and heat at the wound site.
Title
hospital readmissions
Description
need for additional procedures and hospital readmissions related to the index injury will be documented
Title
tibial fracture healing
Description
evidence of bridging callus on three of four cortices assessed by biplanar radiograph
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gustilo type II-IIIa tibia fracture
age greater than 15 years
fractures amenable to intramedullary nailing
Exclusion Criteria:
excessive wound contamination
patient cardio-pulmonary or hemodynamic instability preventing prompt surgical intervention
impaired or absent consciousness
refusal of consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Bosse, MD
Organizational Affiliation
Carolians HealthCare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures
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