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

This study has been completed.
Sponsor:
Collaborators:
Orthopaedic Trauma Association
Orthopaedic Research and Education Fund
Information provided by:
Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT01315392
First received: March 1, 2011
Last updated: March 14, 2011
Last verified: March 2011
  Purpose

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 Intervention
Type II and IIa Open Tibia Fractures
Procedure: delayed closure
Procedure: immediate wound closure

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

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


Enrollment: 451
Study Start Date: July 2000
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Michael J. Bosse, MD, Carolinas HealthCare System
ClinicalTrials.gov Identifier: NCT01315392     History of Changes
Other Study ID Numbers: OTAOREF2000MJB
Study First Received: March 1, 2011
Last Updated: March 14, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 20, 2014