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

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ClinicalTrials.gov Identifier: NCT01315392
Recruitment Status : Completed
First Posted : March 15, 2011
Last Update Posted : March 15, 2011
Sponsor:
Collaborators:
Orthopaedic Trauma Association
Orthopaedic Research and Education Fund
Information provided by:
Carolinas Healthcare System

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.

Condition or disease Intervention/treatment Phase
Type II and IIa Open Tibia Fractures Procedure: delayed closure Procedure: immediate wound closure Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 451 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Randomized Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures: A Pilot Study
Study Start Date : July 2000

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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




Primary Outcome Measures :
  1. infection rate
    defined as cases determined definitively by a positive culture or treated empirically based on tenderness, erythema, and heat at the wound site.

  2. hospital readmissions
    need for additional procedures and hospital readmissions related to the index injury will be documented

  3. tibial fracture healing
    evidence of bridging callus on three of four cortices assessed by biplanar radiograph



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315392


Locations
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
Carolinas Healthcare System
Orthopaedic Trauma Association
Orthopaedic Research and Education Fund
Investigators
Principal Investigator: Michael J Bosse, MD Carolians HealthCare System

Responsible Party: Michael J. Bosse, MD, Carolinas HealthCare System
ClinicalTrials.gov Identifier: NCT01315392     History of Changes
Other Study ID Numbers: OTAOREF2000MJB
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: March 15, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries