Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures

Launched by MAJOR EXTREMITY TRAUMA RESEARCH CONSORTIUM · Mar 22, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment method called incisional negative pressure wound therapy (NPWT) to see if it can help reduce infections and complications in patients with serious fractures of the tibia, which is the bone in your lower leg. The study will involve 352 participants who have specific types of tibial fractures that are at high risk for problems, such as open fractures or fractures that require a large incision. Eligible participants will be randomly assigned to receive either this special wound therapy or a standard dressing for their wounds. The main goal is to evaluate how well the wound has healed and the patient's overall health three months after starting the treatment.

To be eligible for this trial, participants must be 18 years or older and have certain types of tibial fractures that need surgical treatment. For example, they might have a fracture that is open or has been treated with an external fixator. Patients who are currently dealing with an infection in their injury or those who cannot use the NPWT for any reason will not be able to participate. Throughout the trial, participants can expect regular check-ins to monitor their healing and any complications, helping researchers understand if NPWT is a better option for managing these types of wounds.

Gender

ALL

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.