Negative Pressure Wound Therapy for Broken Leg

(iVAC Trial)

Recruiting at 1 trial location

Overseen By Leah Gitajn, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Major Extremity Trauma Research Consortium

Disqualifiers: Infection, Homelessness, Intellectual disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

352 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating serious leg fractures, specifically high-risk tibia (shinbone) fractures. It compares a special vacuum dressing, known as Negative Pressure Wound Therapy, to standard wound care methods to determine which promotes better healing. The goal is to assess patient recovery three months after treatment. Suitable participants have experienced a serious tibia fracture requiring surgery and have a wound larger than 3 cm. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this negative pressure wound therapy is safe for treating broken legs?

Research has shown that incisional negative pressure wound therapy (NPWT) has mixed safety results. Some studies suggest it can reduce the risk of infections at the surgical site compared to regular wound dressings. However, other studies found it might increase the risk of infection. Thus, NPWT might prevent infections in some cases but could cause more infections in others.

Additionally, reports indicate that NPWT can cause swelling in the soft tissue, potentially widening the wound and slowing healing. Despite these concerns, researchers continue to study NPWT due to its potential benefits in certain situations. Overall, while NPWT is generally considered safe, its effects can vary from patient to patient. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for broken legs, which typically involves regular wound care techniques like cleaning and dressing, Incisional Negative Pressure Wound Therapy (NPWT) uses a vacuum to apply controlled negative pressure to the wound site. This method can enhance healing by promoting blood flow and reducing swelling, which standard treatments don't specifically target. Researchers are excited about NPWT because it has the potential to accelerate recovery times and improve outcomes by creating an optimal healing environment, which is a significant advancement over conventional methods.

What evidence suggests that incisional negative pressure wound therapy is effective for treating high-risk tibial fractures?

Research shows that Incisional Negative Pressure Wound Therapy (INPWT) can help prevent complications with surgical wounds, particularly around the ankle and lower leg. In this trial, participants will be randomized into different treatment arms. One group will receive standard wound care, while another will receive INPWT, which might lower the risk of wound infections and reduce the need for additional surgeries in individuals with lower limb injuries. However, not all research agrees. One study found that INPWT did not significantly improve healing for lower leg fractures from major injuries. Overall, while some evidence supports INPWT, the results remain mixed. ^{1 6 7 8 9}

Who Is on the Research Team?

Renan Castillor, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

I. Leah Gitajn, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with specific high-risk fractures (like tibial plateau, pilon, or open tibial shaft) that have been treated surgically. Participants must have at least one wound primarily closed and be at risk of complications. Those with minor wounds or not requiring significant surgical intervention are excluded.

Inclusion Criteria

I had surgery for a high-risk fracture in my lower leg.

I had a closed fracture treated with an external device, and definitive treatment was done more than 3 days after to allow swelling to reduce.

I have an open fracture type I, II, or IIIA.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either incisional negative pressure wound therapy (NPWT) or a non-suction standard-of-care wound dressing

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Incisional Negative Pressure Wound Therapy

Trial Overview The study tests if Incisional Negative Pressure Wound Therapy (NPWT) is better than standard non-suction dressings in managing wounds from certain high-risk fractures. Patients will be randomly assigned to either NPWT or standard care and followed up after 3 months.

How Is the Trial Designed?

Group I: Incisional Negative Pressure Wound Therapy (NPWT) Experimental Treatment 1 Intervention

Patients randomized to the treatment group will receive wound care which includes the application of an incisional negative pressure wound vacuum.

Group II: Standard of Care Wound Care Active Control 1 Intervention

Patients randomized to the control group will receive standard wound care.

Who Is Running the Clinical Trial?

Major Extremity Trauma Research Consortium

Lead Sponsor

Trials

32

Recruited

27,400+

Published Research Related to This Trial

Incisional negative-pressure wound therapy (iNPWT) significantly reduces the rates of incisional infections and the need for revisional surgeries in high-risk patients, with infection rates dropping from 48% to 7% and revisional surgery rates from 48% to 7%.

While iNPWT shows promise in decreasing complications and potentially improving healing after lower-extremity amputations, further prospective randomized trials are necessary to confirm its benefits on morbidity, function, and mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incisional Application of Negative Pressure for Nontraumatic Lower Extremity Amputations: A Review. Kotha, V., Walter, E., Stimac, G., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7042841/

Effect of Incisional Negative Pressure Wound Therapy vs ... The findings do not support the use of incisional negative pressure wound therapy for surgical wounds associated with lower limb fractures from major trauma.

2. withpower.com withpower.com/trial/negative-pressure-wound-therapy-for-broken-leg-9f7be

Negative Pressure Wound Therapy for Broken Leg Research shows that Incisional Negative Pressure Wound Therapy (INPWT) can help prevent complications in surgical wounds, particularly in ankle and distal tibia ...

3. aetna.com aetna.com/cpb/medical/data/300_399/0334.html

Negative Pressure Wound Therapy - Medical Clinical ... The goal of the assessment was to systematically review the efficacy and safety of NPWT for treatment of chronic wounds in the home setting. The authors ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0020138317308021

Closed incision negative pressure therapy decreases ... Our findings suggest that ciNPT may reduce wound complications, SSIs, and reoperations in patients undergoing lower extremity periprosthetic fracture surgery.

5. researchgate.net researchgate.net/publication/392093066_Incisional_Negative_Pressure_Wound_Therapy_Use_on_Orthopaedic_Lower_Extremity_Trauma_An_Updated_Systematic_Global_Review

(PDF) Incisional Negative Pressure Wound Therapy Use ... Results: Of the seven studies, five showed a decreased SSI rate compared to standard wound dressing, with the other two exhibiting an increased ...

6. mdpi.com mdpi.com/2673-866X/5/2/11

Incisional Negative Pressure Wound Therapy Use on ... Results: Of the seven studies, five showed a decreased SSI rate compared to standard wound dressing, with the other two exhibiting an increased infection rate.

7. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00282-1/fulltext

Incisional negative pressure wound therapy for the ... Incisional negative pressure wound therapy for the prevention of surgical site infection: an up-to-date meta-analysis and trial sequential analysis

8. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-08986-1

Closed incision management with negative pressure wound ... We conducted a systematic review and meta-analysis to evaluate the effectiveness of negative pressure wound therapy (NPWT) compared to ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0020138320304265

Safety and Efficacy of Prophylactic Closed Incision ... Soft tissue swelling can increase wound dehiscence and risk of developing a postoperative infection along with causing a delay in early range of motion [1,2].