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

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized trial will use a Negative Pressure Wound Therapy device or standard wound closure, in participants with gastrointestinal neoplasms, to measure the rate of surgical site infections

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 data supports the idea that Negative Pressure Wound Therapy for Surgical Wound is an effective treatment?

The available research shows that Negative Pressure Wound Therapy (NPWT) is effective in promoting wound healing. Studies have demonstrated that NPWT increases blood flow and helps form new tissue, which speeds up the healing process. For example, one study found that NPWT led to faster healing rates compared to traditional methods like moist gauze. Another study highlighted its success in treating a large infected facial wound, showing that it can be effective even in challenging cases. Additionally, research on non-healing lower limb ulcers showed that NPWT resulted in significantly faster healing than conventional treatments. These findings suggest that NPWT is a beneficial treatment for various types of wounds. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Negative Pressure Wound Therapy for surgical wounds?

Research shows that Negative Pressure Wound Therapy (NPWT), also known as vacuum-assisted closure (VAC), helps wounds heal faster by increasing blood flow and reducing fluid and bacteria. It has been effective in treating various types of wounds, including infected and chronic wounds, by promoting the formation of new tissue. ^{1 2 3 4 5}

What safety data exists for Negative Pressure Wound Therapy?

The safety and efficacy of Negative Pressure Wound Therapy (NPWT), also known as Vacuum-Assisted Closure (VAC) or Topical Negative Pressure (TNP) therapy, have been evaluated in various studies. It has been used since the late 1990s for managing acute, traumatic, infected, and chronic wounds. Clinical trials and studies have demonstrated its benefits in promoting faster wound healing compared to conventional therapies. However, the cost of commercially available VAC units can be high, leading to the development of low-cost alternatives. Overall, NPWT is considered effective for wound management, particularly for chronic non-healing wounds. ^{2 3 4 6 7}

Is Negative Pressure Wound Therapy safe for humans?

Negative Pressure Wound Therapy (also known as Vacuum-Assisted Closure or VAC) has been used to treat complex wounds, including those with intestinal fistulas, and is generally considered safe for humans based on existing literature. ^{8 9 10 11 12}

Is Negative Pressure Wound Therapy a promising treatment for surgical wounds?

Yes, Negative Pressure Wound Therapy (also known as vacuum-assisted closure or VAC) is a promising treatment for surgical wounds. It helps wounds heal faster by increasing blood flow, reducing bacteria, and promoting the growth of new tissue. It has been successfully used in various types of wounds, including those that are difficult to heal. ^{1 2 3 4 5}

How does negative pressure wound therapy differ from other treatments for surgical wounds?

Negative pressure wound therapy (NPWT) is unique because it uses a vacuum to apply negative pressure to the wound, which helps increase blood flow, reduce fluid and bacteria, and promote faster healing compared to traditional methods like moist gauze. This therapy is particularly effective for difficult-to-heal wounds and can be more efficient in closing wounds and forming new tissue. ^{1 2 3 4 5}

Research Team

Jose M Pimiento, MD

Principal Investigator

Moffitt Cancer Center

Daniel Anaya, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

The use of vacuum-assisted closure therapy for the treatment of a large infected facial wound. [2006]

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

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

3. England pubmed.ncbi.nlm.nih.gov

An economic evaluation of the use of TNP on full-thickness wounds. [2022]

4. England 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. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Negative pressure wound therapy with intermittent irrigation for treatment of post-traumatic giant abscess: A case report. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Topical negative pressure therapy. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Advances in wound healing: topical negative pressure therapy. [2018]

8. Spain pubmed.ncbi.nlm.nih.gov

[Negative pressure therapy in wounds with enteric fistulas]. [2009]

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

The results of a 6-year epidemiologic surveillance for ventilator-associated pneumonia at a tertiary care intensive care unit in Saudi Arabia. [2012]

10. England pubmed.ncbi.nlm.nih.gov

"Risk factors for ventilator-associated pneumonia following cardiac surgery: case-control study". [2020]

11. Qatar pubmed.ncbi.nlm.nih.gov

Comparison of three interventional approaches to prevent ventilator-associated pneumonia in intensive care units (ICUs): A clinical trial study. [2021]

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

Original Research: Oral Care as Prevention for Nonventilator Hospital-Acquired Pneumonia: A Four-Unit Cluster Randomized Study. [2023]