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

Wake Forest University (WFU)

Status: Completed

Conditions: Type II and IIa Open Tibia Fractures

Treatments: Procedure: delayed closure; Procedure: immediate wound closure

Study type: Interventional

Funder types: Other

Identifiers

NCT01315392

OTAOREF2000MJB

Details and patient eligibility

About

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.

Enrollment: 451 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

451 participants in 2 patient groups

delayed closure

Active Comparator group

Description:

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.

Treatment:

Procedure: delayed closure

immediate wound closure

Active Comparator group

Description:

traumatic and surgical wounds closed at initial surgical intervention

Treatment:

Procedure: immediate wound closure