Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01315392 · ClinicalTrials.gov registry record · NA
A Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures
A NA study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 451
- Enrollment target
NCT01315392: Completed NA study, sponsored by Wake Forest University Health Sciences.
NCT01315392 is a NA study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 451 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01315392, a NA study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 451 participants
- Enrollment target
Study 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.
Primary Outcome
defined as cases determined definitively by a positive culture or treated empirically based on tenderness, erythema, and heat at the wound site.
Interventions
- PROCEDURE delayed closure
- PROCEDURE immediate wound closure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 451 participants |
| Start Date | 2000-07 |
| Phase | NA |
What the finished NCT01315392 record still lists
NCT01315392 is an interventional study that assigns participants to a tested intervention. The registered 451 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which delayed closure is the first listed.
NCT01315392 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01315392 about?
NCT01315392 is a clinical study titled "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 tr...
What is the current status of trial NCT01315392?
This trial is currently completed. It is a NA study. The enrollment target is 451 participants. The study started on 2000-07.
What interventions are being tested in trial NCT01315392?
The interventions under investigation include: delayed closure (PROCEDURE), immediate wound closure (PROCEDURE).
Who is sponsoring clinical trial NCT01315392?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01315392's enrollment target sits among peer trials
451 225th of 2000 higher than 1,776 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05676255 · 452 participants · Phase 2
The Breast Cancer Survivors and Partners Online Research Together (SUPORT) Project
- NCT05703178 · 452 participants · Phase 3
Web-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia
- NCT00515060 · 450 participants
Psychophysical Studies of Cancer Therapy Pain
- NCT01257269 · 450 participants
Genotype and Phenotype Correlation in Hereditary Thrombotic Thrombocytopenic Purpura (Upshaw-Schulman Syndrome)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia