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

Wound Heal Clinical Trial

— iVAC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06337292
• Other study ID #: IRB00440042
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2024
• Source: Major Extremity Trauma Research Consortium
• Contact: Tara Taylor, MPH
• Phone: 4106146081
• Email: ttaylo56[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 352
• Est. completion date: December 31, 2028
• Est. primary completion date: September 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Infected Wound
• Tibial Fractures
• Wound Complication
• Wound Dehiscence
• Wound Heal
• Wound Infection
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Major Extremity Trauma Research Consortium

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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