A Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures

April 19, 2022 updated by: Wake Forest University Health Sciences

A Randomized Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

451

Phase

  • 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

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center

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

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: delayed closure
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.
Procedure: delayed closure
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.
Active Comparator: immediate wound closure
traumatic and surgical wounds closed at initial surgical intervention
Procedure: immediate wound closure
traumatic and surgical wounds closed at the initial surgical intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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

Collaborators and Investigators

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

Sponsor

Wake Forest University Health Sciences

Collaborators

Orthopaedic Trauma Association
Orthopaedic Research and Education Fund

Investigators

  • Principal Investigator: Michael J Bosse, MD, Carolians HealthCare System

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

July 1, 2000

Study Registration Dates

First Submitted

March 1, 2011

First Submitted That Met QC Criteria

March 14, 2011

First Posted (Estimate)

March 15, 2011

Study Record Updates

Last Update Posted (Actual)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTAOREF2000MJB

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.

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