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

Not Applicable

Completed

• Conditions: Type II and IIa Open Tibia Fractures

• Registration Number: NCT01315392
• Lead Sponsor: Wake Forest University Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-07
• Status Verified: 2011-03
• Study First Submitted: 2011-03-01
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-15
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 451

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States