Sponsor:
Major Extremity Trauma Research Consortium
Code:
NCT06337292
Conditions
Fracture of Tibia
Wound Heal
Infected Wound
Wound Complication
Wound Dehiscence
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Interventions
Incisional Negative Pressure Wound Therapy (NPWT)
Brief summary:
Conditions
Fracture of Tibia
Wound Heal
Infected Wound
Wound Complication
Wound Dehiscence
Study ID
NCT06337292
Start date
Jan 1, 2025
Status verified date
May, 2026
Completion date
Dec 31, 2028
Anticipated
Primary completion date
Sep 30, 2028
Anticipated
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Enrollment
352 participants
Anticipated
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary purpose
Treatment
Arms
no intervention: Standard of Care Wound Care
experimental: Incisional Negative Pressure Wound Therapy (NPWT)
Interventions
Incisional Negative Pressure Wound Therapy (NPWT)
Primary outcome measure
Central contacts
Locations
University of Maryland R Adams Cowley Shock Trauma Center
Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator:
Robert O'Toole, MD
University of Maryland Shock Trauma/Capitol Regions
Recruiting
Baltimore, Maryland, United States, 21201
Contacts
Dartmouth-Hitchcock Medical Center
Recruiting
Lebanon, New Hampshire, United States, 03756
Principal Investigator:
Leah Gitajn, MD
Vanderbilt University
Recruiting
Nashville, Tennessee, United States, 37232
Contacts
UTHealth/McGovern Medical School
Recruiting
Houston, Texas, United States, 77030
Contacts
Inova Fairfax MEdical Campus
Recruiting
Falls Church, Virginia, United States, 22042
Contacts
Sponsor
Major Extremity Trauma Research Consortium
Last update posted
May 12, 2026
Last verified
May, 2026
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Major Extremity Trauma Research Consortium on 2026-05-12.