RECRUITING

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

Conditions

Fracture of Tibia Wound Heal Infected Wound Wound Complication Wound Dehiscence

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. The secondary outcomes will independently assess the components of the primary outcome.

Official Title

Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures: A Multicenter Randomized Controlled Trial

Quick Facts

Study Start:2025-01-01

Study Completion:2028-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06337292

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

Leah Gitajn, MD

CONTACT

603-650-5133

ida.leah.gitajn@hitchcock.org

Principal Investigator

I. Leah Gitajn, MD

PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Renan Castillor, PhD

PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Study Locations (Sites)

University of Maryland R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201

United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756

United States

Collaborators and Investigators

Sponsor: Major Extremity Trauma Research Consortium

I. Leah Gitajn, MD, PRINCIPAL_INVESTIGATOR, Dartmouth-Hitchcock Medical Center
Renan Castillor, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins Bloomberg School of Public Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-01

Study Completion Date2028-12-31

Study Record Updates

Study Start Date2025-01-01

Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

Fracture of Tibia
Wound Heal
Infected Wound
Wound Complication
Wound Dehiscence