Negative Pressure Therapy for Surgical Wounds

Overseen By James W Poser, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Progenerative Medical, Inc

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Hepatic insufficiency, Autoimmune diseases, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 2-8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, Regenn® Therapy (a type of negative pressure wound therapy), to determine if it safely aids in healing surgical wounds after spinal fusion surgery. The trial checks for serious side effects, monitors pain levels, and observes any delays in healing. It compares Regenn® Therapy to a similar device. Suitable participants have specific back issues, such as Degenerative Disc Disease (wear and tear on the spinal discs), and are scheduled for lumbar spinal fusion surgery. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking medications that interfere with bone fusion, like steroids, you may need to stop them before surgery.

What prior data suggests that the Regenn® Negative Pressure Therapy System is safe for post-operative surgical wounds?

Previous studies have shown that Negative Pressure Wound Therapy (NPWT) helps wounds heal better by using a gentle vacuum to remove excess fluid. Patients usually tolerate this therapy well. Some have reported minor side effects like skin irritation, but these are uncommon.

The Regenn® Negative Pressure Therapy System is a new device being tested specifically for surgical wounds. As it is in the early stages of testing, information about its safety is limited. However, similar devices have been used safely for other types of wounds, suggesting that the Regenn® system might also be safe. More research is needed to confirm this.

Prospective trial participants should discuss any concerns with their doctor. The doctor can provide more details about what to expect and how the device might affect them. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the Regenn® Negative Pressure Therapy System because it offers a potentially improved approach to managing surgical wounds. Unlike traditional methods like standard wound dressings or other negative pressure systems, Regenn® uses a compact, hand-sized, battery-operated pump that simplifies the delivery of reduced pressure therapy. This device can be applied directly by the surgeon at the end of surgery, potentially increasing precision and convenience. Additionally, its small size and ease of use might enhance patient comfort during recovery, making it a promising alternative to existing options.

What evidence suggests that the Regenn® Negative Pressure Therapy System is effective for surgical wounds?

Research shows that Negative Pressure Wound Therapy (NPWT) effectively manages surgical wounds. Studies have found that NPWT speeds up healing by using a gentle vacuum to remove fluids and reduce swelling. One study found that patients with new wounds healed faster and required fewer surgeries with NPWT. In this trial, participants in the treatment arm will receive the Regenn® Negative Pressure Therapy System, a type of NPWT that uses a small, portable pump for vacuum therapy. While specific data on Regenn® Therapy is still being collected, the overall success of NPWT suggests it could benefit surgical wounds. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for patients having lumbar spinal fusion surgeries. Participants must be in good health, provide a detailed medical history, and list current medications. They'll undergo a physical exam and routine blood tests. Those with certain health conditions or on specific treatments may not qualify.

Inclusion Criteria

Subject has provided written informed consent on a form reviewed and approved by the Institutional Review Board for the clinical site

I have back pain due to a slipped disc or disc degeneration confirmed by tests.

I am willing and able to follow the study's visit and testing schedule.

Exclusion Criteria

Subject is a prisoner

Subject is a smoker

I am significantly overweight, with my weight being over 40% above my ideal body weight.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive the Regenn® Negative Pressure Therapy System or control device post-surgery

2-8 weeks

Continuous application post-surgery

Follow-up

Participants are monitored for safety and effectiveness, including adverse events and pain assessment

3-6 months

2 visits (in-person) at approximately 1 month and 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Regenn® Negative Pressure Therapy System

Trial Overview The study compares the Regenn® Negative Pressure Therapy System with the Prevena™ Incision Management System to see which is safer post-surgery. It looks at serious device-related events, pain levels using a scoring system, other adverse events, and seroma formation rates.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

This group will receive the study device, Regenn® Negative Pressure Therapy System, a form of Negative Pressure Wound Therapy (NPWT). Regenn® Therapy manages the surgical wound by the application of reduced pressure therapy (i.e., mild vacuum). Reduced pressure therapy is controlled by a hand-sized, battery-operated pump and is delivered by an attached small, dressing that the surgeon places in the surgical wound at the end of the surgery. Reduced pressure therapy is applied while the patient recovers from surgery.

Group II: Control Arm Active Control 1 Intervention

This group will receive the control device, also a form of Negative Pressure Wound Therapy (NPWT), which manages the surgical wound by the application of reduced pressure therapy (i.e., mild vacuum). Reduced pressure therapy is controlled by a hand-sized, battery-operated pump and is delivered by a small tube connected to a wound dressing placed over the closed surgical wound at the end of the surgery. Reduced pressure therapy is applied while the patient recovers from surgery.

Regenn® Negative Pressure Therapy System is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Regenn Therapy for:

• Post-operative surgical wounds
• Chronic wounds
• Acute wounds
• Traumatic wounds
• Diabetic foot ulcers
• Pressure ulcers
• Venous ulcers
• Arterial ulcers

Approved in European Union as Negative Pressure Wound Therapy (NPWT) for:

• Chronic wounds
• Acute wounds
• Traumatic wounds
• Diabetic foot ulcers
• Pressure ulcers
• Venous ulcers
• Arterial ulcers

Approved in Canada as Vacuum-Assisted Closure (VAC) for:

• Chronic wounds
• Acute wounds
• Traumatic wounds
• Diabetic foot ulcers
• Pressure ulcers
• Venous ulcers
• Arterial ulcers

Who Is Running the Clinical Trial?

Progenerative Medical, Inc

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

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]

Negative pressure wound therapy (NPWT) is more cost-effective than traditional wound care (TWC) for treating diabetic foot ulcers, with an annual cost of $5165 compared to $9833 for TWC, while also providing similar effectiveness in quality-adjusted life years (QALYs).

NPWT not only reduces overall treatment costs but also decreases the number of amputations and increases the rate of wound healing, making it a beneficial option for both patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Utility Analysis of Negative Pressure Wound Therapy Compared With Traditional Wound Care in the Treatment of Diabetic Foot Ulcers in Iran. Alipour, V., Rezapour, A., Ebrahimi, M., et al.[2021]

Modified nasopharyngeal irrigation, guided by endoscopy, significantly improved recovery rates in patients with mild- and moderate-grade post-radiation nasopharyngeal necrosis (PRNN) compared to traditional self-administered irrigation methods.

The study, which analyzed 113 NPC patients over a 7-year period, found that modified irrigation was associated with better overall survival rates, particularly in patients with lower-risk PRNN and those who had received one course of radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Analysis of a Modified Irrigation Method for Nasopharyngeal Carcinoma Patients With Post-Radiation Nasopharyngeal Necrosis. Xiao, Y., Peng, S., Tang, Y., et al.[2022]

Negative pressure wound therapy (NPWT) requires validation through randomized trials to be properly assessed by experts, highlighting the importance of rigorous research in evaluating its effectiveness.

The French National Authority for Health (HAS) recommends NPWT techniques in hospital surgical departments, but only under specific conditions and with follow-up care at home, indicating a cautious approach to its implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The recommendations of the French National Authority for Health on negative pressure wound therapy]. Téot, L., Trial, C., Brancati, A.[2011]

In a study of 50 post-thoracic surgery patients, the use of noninvasive positive pressure ventilation (NPPV) significantly improved lung re-expansion compared to conventional treatment, reducing the rate of inadequate lung expansion and the volume of residual cavity.

Despite these benefits in lung re-expansion, NPPV did not significantly affect the overall rate of postoperative pulmonary complications or lung function changes, indicating it is safe but may not reduce complications in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic use of noninvasive positive pressure ventilation in post-thoracic surgery patients: A prospective randomized control study. Liao, G., Chen, R., He, J.[2021]

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 of 449 patients receiving noninvasive positive-pressure ventilation (NPPV) for respiratory failure, the intubation rates were similar to those seen in clinical trials for cardiogenic pulmonary edema and COPD exacerbations, but higher for acute hypoxemic respiratory failure.

Patients with acute hypoxemic respiratory failure who failed NPPV had a very high hospital mortality rate of 64%, indicating that NPPV failure is a serious concern and associated with poor outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive positive-pressure ventilation in acute respiratory failure outside clinical trials: experience at the Massachusetts General Hospital. Schettino, G., Altobelli, N., Kacmarek, RM.[2022]

A novel endoscopic surgery for postradiation nasopharyngeal necrosis (PRNN) in 72 patients showed high efficacy, with 70.8% achieving complete healing of the nasopharyngeal defect and significant pain relief after the procedure.

The surgery was safe, with no severe complications reported, and resulted in a 2-year overall survival rate of 77.9%, indicating it is a promising treatment option for patients suffering from this severe complication of nasopharyngeal carcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A curative-intent endoscopic surgery for postradiation nasopharyngeal necrosis in patients with nasopharyngeal carcinoma. Zou, X., Wang, SL., Liu, YP., et al.[2020]

Negative pressure wound therapy with instillation (NPWTi) is emerging as a promising treatment for both acute and chronic wounds, combining the benefits of conventional NPWT with fluid instillation.

While NPWTi shows potential as an effective adjunct for treating critical wounds, there is a lack of robust data from prospective randomized trials to fully validate its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Negative Pressure Wound Therapy with Instillation in the Treatment of Critical Wounds]. Gathen, M., Petri, M., Krettek, C., et al.[2017]

Negative pressure wound therapy (NPWT) has shown an overall success rate of 85.7% in managing head and neck wounds, based on a review of 57 studies involving 522 patients.

NPWT is particularly beneficial for patients with challenging wound healing situations, such as those with a history of head and neck cancer or oro-/pharyngocutaneous fistulas, suggesting its efficacy in complex clinical scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative Pressure Wound Therapy in the Head and Neck: An Evidence-Based Approach. Mir, A., Guys, N., Arianpour, K., et al.[2019]

Negative pressure wound therapy (NPWT) has been an effective treatment for both acute and chronic wounds, significantly improving healing outcomes for millions of patients.

The recent modifications to the vacuum-assisted closure (VAC) system, which now allows for intermittent fluid instillation, enhance its application and effectiveness in wound management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in negative pressure wound therapy: the VAC instill. Jerome, D.[2022]

In a study of 25 patients undergoing V.A.C. (Vacuum Assisted Closure) therapy for chronic wounds, pain levels increased significantly, with average pain scores rising from 4.2 before therapy to 6.2 during the first day of treatment.

Despite the use of pain-killers, the number of lost functional activities increased from 20 to 69 during V.A.C. therapy, indicating that the treatment may lead to greater pain and dependence, which healthcare professionals often underestimate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pain and basic functional activites in a group of patients with cutaneous wounds under V.A.C therapy in hospital setting]. Apostoli, A., Caula, C.[2014]

In a study of 72 patients with acute respiratory failure after abdominal surgery, 67% were able to avoid intubation by using noninvasive positive pressure ventilation (NPPV), indicating its effectiveness as a treatment option.

Patients who successfully used NPPV had significant improvements in oxygen levels and respiratory rates, along with shorter ICU stays and lower mortality rates compared to those who required intubation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of patients with acute respiratory failure after abdominal surgery treated with noninvasive positive pressure ventilation. Jaber, S., Delay, JM., Chanques, G., et al.[2022]

In a study of nine patients with wound complications at ECMO removal sites, negative-pressure wound therapy (NPWT) effectively managed issues like lymphorrhea and skin necrosis, leading to successful wound healing without recurrence of complications.

All patients showed culture conversion to negative for microorganisms after an average of 21.2 days of NPWT, indicating its efficacy in reducing infection risk, and there were no serious complications such as femoral vessel injury during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative-Pressure Wound Therapy for Managing Complicated Wounds at Extracorporeal Membrane Oxygenation Sites. Eom, Y., Woo, KJ.[2019]

In a pilot study involving 130 high-risk patients after upper abdominal surgery, the addition of physiotherapy-led non-invasive ventilation (NIV) to continuous high-flow nasal cannula oxygen therapy (HFNC) did not significantly reduce the incidence of postoperative pulmonary complications (PPCs), with rates of 18% in the HFNC group and 16% in the HFNC plus NIV group.

The study found that while the delivery of continuous HFNC was feasible and safe, the planned NIV sessions were not feasible to complete as intended, leading to the decision not to pursue a larger trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-Invasive Positive airway Pressure thErapy to Reduce Postoperative Lung complications following Upper abdominal Surgery (NIPPER PLUS): a pilot randomised control trial. Lockstone, J., Parry, SM., Denehy, L., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06259409

NCT06259409 | Regenn® Therapy System Safety Study The goal of this clinical trial is to evaluate the safety of the investigational device, Regenn® Negative Pressure Therapy System (Regenn® Therapy), ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9057544/

Effectiveness of negative pressure wound therapy In this study, we aimed to assess the effectiveness of negative pressure wound therapy (NPWT) in a five-year patient cohort and to discuss the results in the ...

3. withpower.com withpower.com/trial/phase-1-surgical-wound-4-2024-a1da6

Negative Pressure Therapy for Surgical Wounds What data supports the effectiveness of the treatment Regenn® Negative Pressure Therapy System for surgical wounds? Negative pressure wound therapy (NPWT) ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1748681524007010

Effectiveness of negative-pressure wound therapy with ... In this study, patients with acute traumatic wounds who received NPWTi-d experienced shorter wound closure time and fewer surgical procedures.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4110389/

Negative Pressure Wound Therapy – A Review of its Uses ... Abstract. The use of Negative Pressure Wound Therapy (NPWT) for complex and large wounds has increased in popularity over the past decade.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6852528/

A prospective, randomized, controlled clinical trial on the ... The s‐NPWT system met noninferiority and achieved statistical superiority vs. t‐NPWT in terms of wound progression toward healing over the treatment period.

7. 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.