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Completed

NCT Number: NCT01315392

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

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.

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Key information

Conditions

Type II and IIa Open Tibia Fractures

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

delayed closure

Procedure

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

Procedure

traumatic and surgical wounds closed at the initial surgical intervention

Primary outcomes

  1. infection rate

    defined as cases determined definitively by a positive culture or treated empirically based on tenderness, erythema, and heat at the wound site.

  2. hospital readmissions

    need for additional procedures and hospital readmissions related to the index injury will be documented

  3. tibial fracture healing

    evidence of bridging callus on three of four cortices assessed by biplanar radiograph

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Orthopaedic Research and Education Fund
  • Orthopaedic Trauma Association

Registry information

Official study title

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

Important dates

Study start
2000
First posted
Mar 15, 2011
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.