Switchable Adhesive Drape for Negative Pressure Wound Therapy

Recruiting at 1 trial location

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

Trial Summary

What is the purpose of this trial?

Negative pressure wound therapy (NPWT) is widely used for chronic and acute wounds, severe burns, and post-operative care. Despite its benefits, the strong adhesive required to maintain an airtight seal increases the risk of medical adhesive-related skin injuries (MARSI), pain, and discomfort during removal. Global Biomedical Technologies (GBT) aims to develop an NPWT drape with "switchable adhesive" technology to enhance removal while maintaining an effective seal. This innovation is expected to benefit both single-use and serial-use NPWT applications by reducing MARSI and improving patient comfort. This project will compare the functionality and acceptability of Comfort Release® NPWT drapes with the industry-standard V.A.C. drape (KCI Technologies, Inc.) in a non-blinded randomized controlled trial. Specific Aims Aim 1: Compare Comfort Release® drapes with V.A.C. drapes in single-use NPWT applications in post-surgical patients (n=200) at Columbia University Medical Center and Weill Cornell Medical Center. Milestones: Demonstrate statistically significant (α=0.05) improvement over V.A.C. drapes in: Reduction of MARSI (Medical Adhesive-Related Skin Injury scoring system) Decreased pain (Indiana Polyclinic Combined Pain Scale) Reduced need for pain/anxiety medication Equivalent or improved seal effectiveness (leak incidence rate) Clinician acceptability Aim 2: Compare Comfort Release® drapes with V.A.C. drapes in serial-use NPWT applications in chronic wound patients (n=100) at Weill Cornell Medical Center. Patients will undergo three NPWT drape changes per week. Milestones: Demonstrate statistically significant (α=0.05) improvement over V.A.C. drapes in: Reduction of MARSI Decreased pain (Indiana Polyclinic Combined Pain Scale) Improved compliance with treatment duration Reduced need for pain/anxiety medication Equivalent or better seal effectiveness Clinician acceptability (questionnaire score \>4) Reduced nursing time by ≥20% Economic value through time and cost savings At each dressing change and final removal, qualitative data from clinicians will assess the acceptability and usability of Comfort Release® NPWT drapes.

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 data supports the effectiveness of the treatment Comfort Release® NPWT drape?

Research shows that a novel hybrid drape used in negative pressure wound therapy (NPWT) can be repositioned easily and removed with less skin irritation compared to traditional drapes. This drape also maintains a good seal without additional products, even in challenging wound areas, which suggests it may be more comfortable and effective for patients. ^{1 2 3 4 5}

How does the Comfort Release® NPWT drape treatment differ from other treatments for wound therapy?

The Comfort Release® NPWT drape is unique because it uses a silicone-acrylic hybrid drape that allows for repositioning after initial placement and easier removal, reducing pain and skin irritation compared to traditional adhesive drapes. This makes it particularly useful for wounds in challenging anatomical areas where maintaining a seal is difficult. ^{1 2 4 6 7}

Research Team

Howard S Rosing, MD, PhD

Principal Investigator

Global Biomedical Technologies, LLC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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 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 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. 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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

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

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

Use of a novel silicone-acrylic drape with negative pressure wound therapy in anatomically challenging wounds. [2021]

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

Finite Element Analysis Modelling of Negative Pressure Wound Therapy Drapes. [2023]

4. United States 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. [2023]

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

Do patient and nurse outcome differences exist between 2 negative pressure wound therapy systems? [2016]

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

Use of abdominal negative pressure wound therapy in different indications: a case series. [2019]

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

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