Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMajor Extremity Trauma Research Consortium
About this trial
This is a multi-center, pragmatic, parallel arm randomized controlled trial (RCT) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision \>3cm. Eligible participants will be randomized to receive either incisional negative pressure wound therapy (NPWT) or a non-suction standard-of-care wound dressing for their definitive wound management. The primary outcome will be a composite outcome to evaluate clinical status 3 months after randomization.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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
Disqualifiers
The study injury is already infected at time of study enrollment.
Patient is unable to receive incisional NPWT for any reason.
Patients who have already had definitive fixation prior to enrollment in the study.
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Incisional Negative Pressure Wound Therapy (NPWT)
DeviceParticipants in the treatment group will be standardized and will receive incisional NPWT using the any incisional VAC system that can apply 75-125mmHg continuous suction to the incision. The VAC sponge will be placed over the surgical wound at least 2cm in width and \>3cm in length.
Treatment groups
352 Participants
are divided into 2 treatment groupsGroup A: Standard of Care Wound CareNo intervention 0 interventions
Group B: Incisional Negative Pressure Wound Therapy (NPWT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complication composite outcome
The primary outcome will be a composite outcome. We will hierarchically assess the components of the composite outcome in the following order: (1) all-cause mortality, (2) injury-related amputation of the lower extremity, (3) number of surgeries to treat a deep or organ space infection (CDC criteria), (4) wound healing complications requiring reoperation, (5) nonoperative wound necrosis at 2 or 6 weeks, wound dehiscence at 2 or 6 weeks or superficial infection (CDC criteria), (6) SCAR-Q Symptom Scale, (7) SCAR-Q Appearance Scale
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov