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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Wound Heal; Wound Complication; Wound Dehiscence; Fracture of Tibia; Infected Wound
• Intervention / Treatment: Device: Incisional Negative Pressure Wound Therapy (NPWT)

• Study Type: Interventional
• Enrollment (Estimated): 352
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Tara Taylor, MPH; Phone Number: 4106146081; Email: ttaylo56@jhu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion 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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Collaborators and Investigators

• Sponsor: Major Extremity Trauma Research Consortium

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Leg Injuries; Wounds and Injuries; Fractures, Bone; Tibial Fractures; Wound Infection
• Other Study ID Numbers: IRB00440042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No