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

NCT01315392 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 451

Last updated 2022-04-21

No results posted yet for this study

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.

Conditions

  • Type II and IIa Open Tibia Fractures

Interventions

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.

PROCEDURE

immediate wound closure

traumatic and surgical wounds closed at the initial surgical intervention

Sponsors & Collaborators

  • Orthopaedic Trauma Association

    collaborator OTHER

  • Orthopaedic Research and Education Fund

    collaborator UNKNOWN

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Michael J Bosse, MD · Carolians HealthCare System

Study Design

Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01315392 on ClinicalTrials.gov