Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
NCT ID:
NCT06337292
Eligibility Criteria:
Inclusion Criteria:
1. All open or closed tibial plateau or pilon fractures treated operatively with internal fixation at high risk for complication. Any open Gustilo Type I, II or IIIA tibial shaft fracture treated definitively with internal or external fixation with or without ipsilateral leg compartment syndrome if at least one wound is primarily closed.
2. We define high-risk fractures as those that are either:
* Closed fracture initially treated with an external fixator (with or without limited internal fixation) and treated definitive more than 3 days later after swelling has resolved;
* Any open type I, II or IIIA fracture, regardless of timing of definitive treatment;
* Any tibial plateau fracture associated with ipsilateral leg compartment syndrome fasciotomy wounds that has at least one wound primarily closed
3. Requiring incision for fixation or debridement of 3 cm or greater.
4. Patients 18 years of age or older
Exclusion Criteria:
1. The study injury is already infected at time of study enrollment.
2. Patient is unable to receive incisional NPWT for any reason.
3. Patients who have already had definitive fixation prior to enrollment in the study.
4. Severe problems with maintaining follow-up (e.g., patients who are homeless at the time of injury or those who are intellectually challenged without adequate family support or who are prisoners).
5. The study injury is a Gustilo Type IIIB or IIIC open fracture.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06337292
Study Brief:
Protocol Section:
NCT06337292