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

NCT ID: NCT01315392

Last Updated: 2022-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

451 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type II and IIa Open Tibia Fractures

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

delayed closure

Intervention Type PROCEDURE

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.

immediate wound closure

traumatic and surgical wounds closed at initial surgical intervention

Group Type ACTIVE_COMPARATOR

immediate wound closure

Intervention Type PROCEDURE

traumatic and surgical wounds closed at the initial surgical intervention

Interventions

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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.

Intervention Type PROCEDURE

immediate wound closure

traumatic and surgical wounds closed at the initial surgical intervention

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orthopaedic Trauma Association

OTHER

Sponsor Role collaborator

Orthopaedic Research and Education Fund

UNKNOWN

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael J Bosse, MD

Role: PRINCIPAL_INVESTIGATOR

Carolians HealthCare System

Locations

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Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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OTAOREF2000MJB

Identifier Type: -

Identifier Source: org_study_id

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