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

NCT06337292 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2026-05-12

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

Incisional Negative Pressure Wound Therapy (NPWT)

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.

Sponsors & Collaborators

  • Major Extremity Trauma Research Consortium

    lead OTHER

Principal Investigators

  • I. Leah Gitajn, MD · Dartmouth-Hitchcock Medical Center

  • Renan Castillor, PhD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2028-09-30
Completion
2028-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06337292 on ClinicalTrials.gov