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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Major Extremity Trauma Research Consortium
Study ID
NCT06337292
Phase
PHASE3
Status
Recruiting
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Conditions

  • Fracture of Tibia
  • Infected Wound
  • Wound Complication
  • Wound Dehiscence
  • Wound Heal

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Incisional Negative Pressure Wound Therapy (NPWT) — DEVICE
    Participants 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.

Study Details

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.

Key Dates

Start date
Jan 1, 2025
Status verified
May 2026
Primary completion
Sep 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
352 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard of Care Wound Care
    Patients randomized to the control group will receive standard wound care.
  • Experimental: Incisional Negative Pressure Wound Therapy (NPWT)
    Patients randomized to the treatment group will receive wound care which includes the application of an incisional negative pressure wound vacuum.

Primary Outcome Measure

Complication composite outcome [ Time Frame: 3 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of Maryland R Adams Cowley Shock Trauma CenterBaltimoreMaryland21201
Robert O'Toole, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland Shock Trauma/Capitol RegionsBaltimoreMaryland21201
Yasmin Degani
[email protected]
(410) 706-5917
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756
Leah Gitajn, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt UniversityNashvilleTennessee37232
Karen Trochez
[email protected]
(615) 936-0347
UTHealth/McGovern Medical SchoolHoustonTexas77030
Keyla Guevara
[email protected]
713-500-6260
Inova Fairfax MEdical CampusFalls ChurchVirginia22042
Senay Ghidei
[email protected]
(703) 526-4382

Find similar trials in Baltimore, MD

By research site
University of Maryland R Adams Cowley Shock Trauma Center· Baltimore, MDUniversity of Maryland Shock Trauma/Capitol Regions· Baltimore, MDDartmouth-Hitchcock Medical Center· Lebanon, NHVanderbilt University· Nashville, TNUTHealth/McGovern Medical School· Houston, TXInova Fairfax MEdical Campus· Falls Church, VA

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