Switchable Adhesive Drape for Negative Pressure Wound Therapy

Recruiting at 3 trial locations

Overseen By Howard S Rosing, Sponsor, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Global Biomedical Technologies, LLC

Disqualifiers: Hypersensitivity to adhesives, alcohol, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1-8 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of bandage for negative pressure wound therapy (NPWT), used to treat wounds and burns. The study compares a new "switchable adhesive" drape, Comfort Release® NPWT drape, designed to be less painful and reduce skin injuries during removal, against the standard V.A.C. drape. It targets individuals who have undergone surgery and need NPWT or those with chronic wounds requiring frequent dressing changes. Participants must report pain levels and commit to clinic visits for dressing changes. The goal is to determine if the new drape is as effective but more comfortable and easier to use. As an unphased trial, this study allows participants to contribute to innovative wound care solutions that could enhance comfort and healing for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions a focus on reducing the need for pain and anxiety medication, which might suggest some changes in medication use during the trial.

What prior data suggests that this switchable adhesive drape is safe for negative pressure wound therapy?

Research has shown that traditional negative pressure wound therapy (NPWT) is commonly used and generally safe. It speeds up wound healing by applying a vacuum to the wound area. However, the strong adhesive used with traditional NPWT can sometimes damage the skin and cause discomfort upon removal.

The new Comfort Release® NPWT drape addresses this issue with a "switchable adhesive" that is gentler on the skin. Although specific safety data for the Comfort Release® drape is not detailed, its design suggests it should reduce skin injuries and pain compared to standard NPWT drapes.

Prospective trial participants should know that potential benefits include easier and less painful removal, which could enhance comfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Switchable Adhesive Drape for Negative Pressure Wound Therapy (NPWT) because it offers a new approach to treating wounds. Unlike traditional NPWT options, which typically use a standard adhesive drape that can be uncomfortable or difficult to remove, the Comfort Release® drape introduces a switchable adhesive technology. This means it can be more easily removed without causing additional pain or damage to the skin. By potentially enhancing patient comfort and simplifying the dressing change process, this advancement could improve the overall experience and outcomes for patients undergoing NPWT.

What evidence suggests that the Comfort Release® NPWT drape is effective for reducing MARSI and improving patient comfort?

This trial will compare the Comfort Release® NPWT drape with the V.A.C. drape in two different applications. Research has shown that the Comfort Release® NPWT drape may reduce pain and skin injury compared to regular drapes. Studies found that this drape uses a special adhesive that is easy to remove, resulting in less pain and skin damage for patients. Patients reported high satisfaction with the Comfort Release® drapes, noting less discomfort during dressing changes. The drape also maintains a good seal, which is crucial for proper wound healing. Overall, this new drape could make negative pressure wound therapy more comfortable without compromising effectiveness. ^{3 6 7 8 9}

Who Is on the Research Team?

Howard S Rosing, MD, PhD

Principal Investigator

Global Biomedical Technologies, LLC

Are You a Good Fit for This Trial?

This trial is for post-surgical patients and those with chronic wounds who are undergoing negative pressure wound therapy (NPWT). Participants must be able to undergo multiple drape changes if in the serial-use group. Those with a history of adhesive dermatitis or tape allergies, as well as noncompliance issues, may not qualify.

Inclusion Criteria

I am over 18 and will be treated with NPWT after surgery.

Access to V.A.C. by KCI drape and NPWT kits

Able to report pain level using a pain scale.

Exclusion Criteria

History of known hypersensitivity to isopropyl alcohol

I have had negative pressure wound therapy in the last 3 months.

History of known hypersensitivity to acrylic adhesives

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NPWT drape applications, comparing Comfort Release® drapes with V.A.C. drapes in both single-use and serial-use settings

1-8 weeks

3 visits per week for serial-use group

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of MARSI, pain, and seal integrity

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Comfort Release® NPWT drape

Trial Overview The study tests Comfort Release® NPWT drapes against standard V.A.C. drapes used in NPWT. It aims to see if the new drapes cause less skin irritation and pain during removal, require fewer pain medications, maintain an effective seal on wounds, and are preferred by clinicians.

How Is the Trial Designed?

Group I: Single use post surgical NPWT drape application Active Control 1 Intervention

Aim 1 description: A comparison of performance of Comfort Release® drapes with V.A.C. drapes in single-use NPWT applications in a randomized controlled trial. Post-surgical patients (n=200) with a prescribed treatment of Negative Pressure Wound Therapy (NPWT), will be enrolled at Weill Cornell under PI. Dr. Robert Winchell and at Columbia Presbyterian hospital under co-Principal Investigator Dr. Jarrod Bogue, and Absolute Medical Center under PI: Daniel Careage, MD, for single-use NPWT. Patients will be randomized to a single use control (V.A.C. drape) or intervention (Comfort Release® drape). All other components of the NPWT device including but not limited to the pump, tubing, foam or dressing insert and will be identical. Randomize patients- 1/2 of the patients to receive KCI drape and 1/2 to receive the intervention - Comfort Release drape. The intervention is a change in a component in the NPWT treatment kit.

Group II: Multi-use chronic wound NPWT drape application Active Control 1 Intervention

Aim 2: A comparison of the performance of Comfort Release® drapes with V.A.C. drapes in serial-use NPWT applications in a randomized controlled trial. Chronic wound patients (n=100) with prescribed NPWT will be enrolled at Weill Cornell Medical Center under Principal Investigator Dr. Robert Winchell and Vital Medical Research under Deeza Frankel, DPM. All patients will undergo 3 NPWT drape changes per week. Patients will be randomized to control (V.A.C. drape.) or intervention (Comfort Release® drape) for the duration of their study enrollment. All other components of the NPWT device including but not limited to the pump, tubing, foam or dressing insert will be identical. Randomize patients- 1/2 of the patients to receive KCI drape and 1/2 to receive the intervention- Comfort Release drape. The intervention is a change in a component in the NPWT treatment kit.

Who Is Running the Clinical Trial?

Global Biomedical Technologies, LLC

Lead Sponsor

Trials

1

Recruited

300+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

Abdominal negative pressure wound therapy (NPWT) is a new technology that effectively manages wounds in open abdomen cases, preventing complications like organ rupture and fatal bleeding.

The use of a polyurethane foam in abdominal NPWT helps ensure that the sponge does not adhere to intra-abdominal organs, enhancing safety during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of abdominal negative pressure wound therapy in different indications: a case series. Kocaaslan, FND., Ozkan, MC., Akdeniz, Z., et al.[2019]

In a case series involving 4 patients with periwound skin breakdown, the use of a novel silicone-acrylic hybrid drape (HA-drape) with negative pressure wound therapy (NPWT) led to significant improvement in periwound skin after just one dressing change.

All patients reported reduced pain during dressing removal, indicating that the HA-drape not only helped maintain a seal but also enhanced patient comfort compared to traditional drapes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Novel Silicone-Acrylic Drape with Negative Pressure Wound Therapy in Four Patients with Periwound Skin Breakdown. Greenstein, E., Moore, N.[2021]

Negative pressure wound therapy with instillation-dwell (NPWTi-d) enhances traditional NPWT by combining the benefits of fluid instillation with negative pressure, improving treatment outcomes for wounds.

Proper application of the dressing and drape is crucial for maximizing the effectiveness of NPWTi-d, particularly in treating orthopedic trauma wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative Pressure Wound Therapy With Instillation-Dwell in Orthopaedic Trauma: How to Avoid Leaks and Frustration. Duda, M., Kim, P.[2022]

A novel hybrid drape for negative pressure wound therapy (NPWT) allows for repositioning after initial placement, which was successfully tested on six patients with anatomically challenging wounds, showing no skin irritation during repositioning.

The use of the hybrid drape enabled the creation of a stable negative pressure seal without the need for ancillary products in most cases, demonstrating its efficacy in maintaining wound treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a novel silicone-acrylic drape with negative pressure wound therapy in anatomically challenging wounds. Fernández, LG., Matthews, MR., Benton, C., et al.[2021]

Negative Pressure Wound Therapy (NPWT) is effective in promoting granulation tissue production through the application of negative pressure, but achieving a proper seal on complex anatomical sites like hands and feet can be challenging.

The authors introduce a new 'sandwich technique' for sealing NPWT foam using a combination of acrylic and soft silicone drapes, which improves the efficiency and effectiveness of the seal on difficult-to-treat areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The sandwich technique for quick and efficient application of negative pressure wound therapy to the feet and hands: a case report. Rollins, A., Ho, K., Fernandez, LG., et al.[2023]

The novel hybrid NPWT drape, which combines acrylate and silicone adhesives, significantly reduces skin strain during removal compared to traditional acrylate drapes, with maximum principal strain dropping from 47.3% to 21.5%.

The hybrid drape also requires a higher peel force (112.5 gf/in) than the acrylate drape (66.1 gf/in), suggesting it may be gentler on the skin and potentially reduce pain and skin damage during the removal process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finite Element Analysis Modelling of Negative Pressure Wound Therapy Drapes. McNulty, AK., Wilkes, R., Bjork, J., et al.[2023]

In a study involving 11 adult male subjects, there were no significant differences in wound healing rates, pain levels, or hospital length of stay between foam-based and gauze-based negative pressure wound therapy (NPWT) systems.

Both NPWT systems had similar costs and did not differ in the ease of use or time taken for dressing changes, suggesting that either system could be effectively used for wound care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do patient and nurse outcome differences exist between 2 negative pressure wound therapy systems? Albert, NM., Rock, R., Sammon, MA., et al.[2016]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10920025

Surgical drape with a releasable acrylic adhesive for ... 2) Compare performance of Comfort Release® drapes with V.A.C. drapes in serial-use NPWT applications in a randomized controlled trial. Chronic wound patients (n ...

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. trialstoday.org trialstoday.org/trial/NCT06717308

Evaluation of a Switchable Acrylic Adhesive Drape ... This project will compare the functionality and acceptability of Comfort Release® NPWT drapes with the industry-standard VAC drape (KCI Technologies, Inc.)

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/08/NCT06717308/Prot_000.pdf

Surgical Drape with a Releasable Acrylic Adhesive for ... This strong skin bonding adhesive Negative Pressure Wound Therapy (NPWT) drape, when properly triggered, releases with less pain and trauma to ...

5. healthcare-bulletin.co.uk healthcare-bulletin.co.uk/article/effectiveness-of-negative-pressure-wound-therapy-in-the-management-of-complex-surgical-wounds-3078/

Effectiveness of Negative Pressure Wound Therapy in the ... The present study demonstrates that Negative Pressure Wound Therapy (NPWT) significantly enhances wound healing in patients with complex surgical wounds ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/08/NCT06717308/Prot_004.pdf

Study Protocol This strong skin bonding adhesive Negative Pressure Wound Therapy (NPWT) drape ... 2) Less time to remove the Comfort Release® NPWT drape and the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4731696/

Simplified Negative Pressure Wound Therapy Device for ... Negative pressure wound therapy (NPWT) is the application of a controlled vacuum to a wound cavity. It has been clinically demonstrated to speed the healing ...

8. healogics.com healogics.com/blog/negative-pressure-wound-therapy-how-this-advanced-treatment-accelerates-healing/

Negative Pressure Wound Therapy: How This Advanced ... In split-thickness skin graft procedures, NPWT has shown improved graft survival rates compared to conventional mechanical fixation methods, ...

9. healthcare-bulletin.co.uk healthcare-bulletin.co.uk/article/effectiveness-of-negative-pressure-wound-therapy-in-the-management-of-complex-surgical-wounds-3078/

Effectiveness of Negative Pressure Wound Therapy in the ... These findings indicate that NPWT significantly improves clinical outcomes in complex surgical wound management in terms of wound healing, infection control, ...