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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Incisional Negative Pressure Wound Therapy for broken legs?

Research shows that Incisional Negative Pressure Wound Therapy (INPWT) can help prevent complications in surgical wounds, particularly in ankle and distal tibia fractures, which are similar to broken legs. This suggests it might be effective in managing wounds from broken legs as well. ^{1 2 3 4 5}

Is negative pressure wound therapy safe for treating wounds?

Negative pressure wound therapy (NPWT) has been used safely in various conditions, including ankle fractures, emergency surgeries, and amputations, to reduce complications like infections and the need for additional surgeries. ^{3 6 7 8 9}

How does Incisional Negative Pressure Wound Therapy differ from other treatments for broken leg wounds?

Incisional Negative Pressure Wound Therapy (INPWT) is unique because it uses a vacuum to help wounds heal by removing excess fluid and reducing swelling, which can prevent complications like infections. This method is different from traditional dressings that simply cover the wound without actively promoting healing. ^{1 3 10 11 12}

Research Team

I. Leah Gitajn, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Renan Castillor, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Negative-pressure wound therapy over surgically closed wounds in open fractures. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Negative pressure dressings are no better than standard dressings for open fractures. [2019]

3. Italy pubmed.ncbi.nlm.nih.gov

Prevention of postoperative surgical wound complications in ankle and distal tibia fractures: results of Incisional Negative Pressure Wound Therapy. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Negative pressure wound therapy after severe open fractures: a prospective randomized study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Negative pressure wound therapy reduces deep infection rate in open tibial fractures. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Incisional Application of Negative Pressure for Nontraumatic Lower Extremity Amputations: A Review. [2022]

7. India pubmed.ncbi.nlm.nih.gov

Impact of negative pressure wound therapy on open diaphyseal tibial fractures: A prospective randomized trial. [2020]

8. Japan pubmed.ncbi.nlm.nih.gov

Prophylactic effect of negative-pressure wound therapy and delayed sutures against incisional-surgical site infection after emergency laparotomy for colorectal perforation: A multicenter retrospective cohort study. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Negative pressure wound therapy vs. conventional management in open tibia fractures: Systematic review and meta-analysis. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of Incisional Negative Pressure Wound Therapy on Surgical Site Infections in High-Risk Reoperative Colorectal Surgery: A Randomized Controlled Trial. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

The use of negative-pressure wound therapy (NPWT) in the temporary treatment of soft-tissue injuries associated with high-energy open tibial shaft fractures. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Negative pressure wound therapy to treat hematomas and surgical incisions following high-energy trauma. [2022]