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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01315392

Enrollment

451

Registered

2011-03-15

Start date

2000-07-31

Completion date

Unknown

Last updated

2022-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type II and IIa Open Tibia Fractures

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.

Interventions

PROCEDUREdelayed 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.

PROCEDUREimmediate wound closure

traumatic and surgical wounds closed at the initial surgical intervention

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026