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

Type II and IIa Open Tibia Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01315392
• Other study ID #: OTAOREF2000MJB
• Status: Completed
• Phase: N/A
• Start date: July 2000

Study information

• Verified date: March 2011
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Fractures
• Type II and IIa Open Tibia Fractures

Intervention

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.
• immediate wound closure
traumatic and surgical wounds closed at the initial surgical intervention

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Orthopaedic Research and Education Fund, Orthopaedic Trauma Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	infection rate	defined as cases determined definitively by a positive culture or treated empirically based on tenderness, erythema, and heat at the wound site.
Primary	hospital readmissions	need for additional procedures and hospital readmissions related to the index injury will be documented
Primary	tibial fracture healing	evidence of bridging callus on three of four cortices assessed by biplanar radiograph