Negative Pressure Therapy for Surgical Wounds

Overseen By James W Poser, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Progenerative Medical, Inc

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Hepatic insufficiency, Autoimmune diseases, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the safety of the investigational device, Regenn® Negative Pressure Therapy System (Regenn® Therapy), a form of Negative Pressure Wound Therapy (NPWT), in the post-operative surgical wounds of patients undergoing lumbar spinal fusion surgeries. The main questions the study aims to answer are: * The device-related serious adverse event rate. * Patient post-operative pain as assessed using a validated pain measurement scoring system. * The number and type of adverse events. * The rate of delayed seroma formation. Participants will * Be screened for their suitability to participate in the investigational study using questions about their health, medical history, and current medications. * Undergo a physical exam, an assessment of patient vital signs and routine blood analyses. * Complete an Informed Consent Form if selected to participate in the investigational study. * Be randomly assigned to the different study arms. * Not change the operation of their respective device or to disturb components of their device. * Notify their surgeon or designated healthcare provider should they have any questions or encounter any issues with their device. * Attend two post-operative visits at approximately one month and three months.

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 data supports the effectiveness of the treatment Regenn® Negative Pressure Therapy System for surgical wounds?

Negative pressure wound therapy (NPWT) is recommended by the French National Authority for Health for use in hospitals, and it is considered the gold standard for treating infected wounds. This suggests that NPWT, including systems like Regenn®, is effective in managing surgical wounds. ^{1 2 3 4 5}

Is negative pressure therapy safe for surgical wounds?

Negative pressure therapy, also known as vacuum-assisted closure (VAC) or negative pressure wound therapy (NPWT), has been studied for managing complicated wounds, including those at sites where extracorporeal membrane oxygenation (ECMO) is removed. While the research primarily focuses on effectiveness, it implies that the therapy is generally safe for use in humans. ^{6 7 8 9 10}

How is the Regenn® Negative Pressure Therapy System different from other treatments for surgical wounds?

The Regenn® Negative Pressure Therapy System, also known as vacuum-assisted closure, is unique because it uses negative pressure to stabilize the wound environment, increase blood flow, and promote tissue growth, which can lead to better healing outcomes compared to traditional wound care methods. ^{11 12 13 14 15}

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Regenn® Negative Pressure Therapy System (Negative Pressure Wound Therapy)

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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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]

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 (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]

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]

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 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]

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]

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]

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 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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Retrospective Analysis of a Modified Irrigation Method for Nasopharyngeal Carcinoma Patients With Post-Radiation Nasopharyngeal Necrosis. [2022]

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

A curative-intent endoscopic surgery for postradiation nasopharyngeal necrosis in patients with nasopharyngeal carcinoma. [2020]

3. France pubmed.ncbi.nlm.nih.gov

[The recommendations of the French National Authority for Health on negative pressure wound therapy]. [2011]

4. Germany pubmed.ncbi.nlm.nih.gov

[Negative Pressure Wound Therapy with Instillation in the Treatment of Critical Wounds]. [2017]

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

Negative Pressure Wound Therapy in the Head and Neck: An Evidence-Based Approach. [2019]

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

Outcomes of patients with acute respiratory failure after abdominal surgery treated with noninvasive positive pressure ventilation. [2022]

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

Negative-Pressure Wound Therapy for Managing Complicated Wounds at Extracorporeal Membrane Oxygenation Sites. [2019]

8. China pubmed.ncbi.nlm.nih.gov

Prophylactic use of noninvasive positive pressure ventilation in post-thoracic surgery patients: A prospective randomized control study. [2021]

9. England 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. [2022]

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

Noninvasive positive-pressure ventilation in acute respiratory failure outside clinical trials: experience at the Massachusetts General Hospital. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

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

12. Italy 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]. [2014]

13. England pubmed.ncbi.nlm.nih.gov

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

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

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

15. United States 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. [2021]