Negative Pressure Wound Therapy for Surgical Wound

Overseen By Daniel Anaya, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Pregnancy, Emergency surgery, others

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

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for healing surgical wounds called Negative Pressure Wound Therapy (NPWT). Researchers aim to determine if NPWT reduces the risk of infections after surgery compared to standard wound care. Participants will either use the NPWT device or receive usual wound treatment post-surgery. The trial seeks individuals undergoing surgery for gastrointestinal cancer with an expected wound larger than 5 cm to be closed with stitches or staples. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in surgical wound care.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

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 the Negative Pressure Wound Therapy device is safe for surgical wound treatment?

Research has shown that Negative Pressure Wound Therapy (NPWT) is generally safe and well-tolerated by patients. This treatment aids wound healing by gently removing fluid from the wound area, reducing swelling and promoting recovery.

Although NPWT is effective, it carries some rare risks, such as bleeding, which can occasionally be severe, and wound infection. However, these issues are uncommon. NPWT is considered necessary for certain types of wounds, with its benefits often outweighing the risks.

In summary, NPWT has proven safe for many patients, with only rare side effects reported. Patients should always discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Negative Pressure Wound Therapy (NPWT) because it offers a unique approach to healing surgical wounds. Unlike standard wound care, which typically involves regular dressing changes and topical treatments, NPWT creates a vacuum environment over the wound. This method not only removes excess fluid and reduces swelling but also promotes blood flow and tissue growth, potentially speeding up the healing process. By actively managing wound conditions, NPWT aims to improve recovery times and outcomes for patients compared to traditional methods.

What evidence suggests that Negative Pressure Wound Therapy is effective for surgical wound infections?

Research shows that Negative Pressure Wound Therapy (NPWT), which participants in this trial may receive, can aid wound healing by lowering the air pressure around the wound. This therapy applies to both open and closed surgical wounds. Studies have found that NPWT likely results in fewer surgical site infections (SSIs) compared to regular dressings. Specifically, 8.7% of patients using NPWT experienced SSIs, while 11.75% of those with standard care did. This suggests NPWT can effectively reduce infections after surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Jose M Pimiento, MD

Principal Investigator

Moffitt Cancer Center

Daniel Anaya, MD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with gastrointestinal cancer who are scheduled for surgery resulting in a wound larger than 5cm, which will be closed primarily. Participants must consent to the study and commit to its procedures. Excluded are emergency surgeries, dirty wounds, secondary closures, psychological conditions that may interfere with participation, or pregnancy.

Inclusion Criteria

I am scheduled for surgery to treat my gastrointestinal cancer.

I am scheduled for surgery that will result in a wound larger than 5cm.

I am willing and able to follow all study rules and attend all appointments.

Exclusion Criteria

I am scheduled for surgery to allow my wound to heal naturally.

History or current diagnosis of any medical or psychological condition that in the Investigator's opinion, might interfere with the subject's ability to participate in the study or the inability to obtain informed consent because of psychiatric or complicating medical problems

I am not pregnant, as confirmed by a urine test on the day of surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical procedures followed by either standard wound therapy or Negative Pressure Wound Therapy (NPWT)

7 days

Postoperative visits on day 3 and day 7

Follow-up

Participants are monitored for surgical site infections and return to oncologic therapy

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Negative Pressure Wound Therapy

Trial Overview The trial tests Negative Pressure Wound Therapy (NPWT) against standard wound closure techniques in patients undergoing surgery for gastrointestinal malignancies. The main goal is to compare the rate of surgical site infections between these two methods.

How Is the Trial Designed?

Group I: NPWT - Negative Pressure Wound Therapy Experimental Treatment 1 Intervention

Participants will receive Negative Pressure Wound Therapy (NPWT) after surgery and wear the NPWT until postop day 3. NPWT dressing will be removed and a new NPWT will be replaced until Postop day 7, where NPWT dressing will be removed.

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

Participants will receive standard of care wound therapy after surgery. Postop day 3, dressings will be removed and new sterile dressings will be applied if needed.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Published Research Related to This Trial

Topical negative pressure therapy (TNP) is a new technique designed to improve the healing of slow-to-heal wounds by applying controlled suction to the wound surface.

The paper discusses how TNP may enhance wound management by promoting better healing conditions, although it emphasizes that the concept of using suction in wound care is not entirely new.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in wound healing: topical negative pressure therapy. Jones, SM., Banwell, PE., Shakespeare, PG.[2018]

Negative pressure wound therapy (NPWT) effectively treated a giant hepatic abscess in a 28-year-old male after a gunshot wound, leading to significant reduction in abscess size and cessation of bile leakage over 15 days.

NPWT, especially with instillation therapy, can be beneficial even in the presence of infection, highlighting its potential as an adjunctive treatment for complex wounds like abscesses, although its use in such cases is still not fully established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative pressure wound therapy with intermittent irrigation for treatment of post-traumatic giant abscess: A case report. Abidali, M., Bauer, F., Gottlieb, M., et al.[2022]

In a study involving 10 patients treated with vacuum-assisted closure (VAC) therapy, significant local clinical improvement was observed in all 3 cases of patients with intestinal fistulas, leading to better symptom control.

VAC therapy, despite its controversial use for intestinal fistulas, demonstrated potential benefits in improving wound conditions and patient comfort, although two patients ultimately passed away due to their complex medical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Negative pressure therapy in wounds with enteric fistulas]. Ruiz-López, M., Carrasco Campos, J., Sánchez Pérez, B., et al.[2009]

Negative-pressure wound therapy, or vacuum-assisted closure (VAC) therapy, has been shown to enhance wound healing by increasing blood flow and granulation tissue formation while reducing fluid and bacteria accumulation.

This report highlights the successful application of VAC therapy on a large infected facial wound, demonstrating its potential effectiveness in challenging wound locations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of vacuum-assisted closure therapy for the treatment of a large infected facial wound. Schuster, R., Moradzadeh, A., Waxman, K.[2006]

In a study involving 54 patients with full-thickness wounds, topical negative pressure (TNP) therapy showed significantly higher material costs compared to conventional moist gauze treatment, but it resulted in lower nursing expenses and shorter hospital stays.

Despite the higher material costs associated with TNP, the overall costs per patient were similar to those of conventional therapy due to reduced dressing changes and quicker readiness for surgical closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An economic evaluation of the use of TNP on full-thickness wounds. Mouës, CM., van den Bemd, GJ., Meerding, WJ., et al.[2022]

In a study of 60 lower socio-economic patients with non-healing lower limb ulcers, negative-pressure wound therapy (VAC) significantly improved healing outcomes, with 96% of patients showing no discharge after 7 weeks compared to only 54% in the conventional dressing group.

The VAC therapy group also demonstrated a greater average wound size reduction of 56%, compared to 29% in the conventional group, indicating that VAC is an effective and satisfactory treatment option for patients who cannot afford commercial VAC units.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of low-cost custom made VAC therapy compared with conventional wound dressings in the treatment of non-healing lower limb ulcers in lower socio-economic group patients of Kashmir valley. Ali, Z., Anjum, A., Khurshid, L., et al.[2019]

Topical negative pressure therapy (TNP) has been effectively used in wound management since the late 1990s, particularly for chronic nonhealing wounds.

Recent studies suggest that TNP not only aids in healing but also plays a beneficial role in preparing the wound bed for further treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical negative pressure therapy. Collier, M.[2017]

Negative pressure wound therapy (NPWT), also known as topical negative pressure or VAC, is a technique that promotes healing in various types of wounds by applying negative pressure.

Over the past 50 years, NPWT has been shown to effectively enhance wound healing, leading to the development of multiple devices that provide healthcare professionals with more options for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview of negative pressure wound therapy (NPWT). Thompson, G.[2008]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK576388/

Negative Pressure Wound Therapy - StatPearls - NCBI - NIH It can be utilized to manage acute and chronic wounds, ranging from open fasciotomy wounds and diabetic foot ulcers to closed surgical incisions. NPWT has ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0011384014000847

Effect of negative pressure wound therapy on wound healing Negative pressure wound therapy (NPWT) is a term that refers to any device that applies differential suction (ie, reduced local pressure) to wounds.

3. journals.lww.com journals.lww.com/jtrauma/fulltext/2025/08001/negative_pressure_wound_therapy_in.21.aspx

Negative pressure wound therapy in resource-limited... Negative pressure wound therapy alters the local wound environment through a variety of mechanisms at both the macroscopic and microscopic level to reduce edema ...

4. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/vacuumassisted-closure-of-a-wound

Vacuum-Assisted Closure of a Wound Vacuum-assisted closure of a wound is a type of therapy to help wounds heal. It's also known as wound VAC. During the treatment, a device decreases air ...

5. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD009261.pub7/full

Negative pressure wound therapy for surgical ... There is moderate‐certainty evidence that NPWT probably results in fewer SSIs (8.7% of participants) than treatment with standard dressings (11.75%) after ...

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

Negative Pressure Wound Therapy - Medical Clinical ... Aetna considers negative pressure wound therapy (NPWT) pumps medically necessary, when either of the following criteria (A or B) is met.