Evaluation of a Switchable Acrylic Adhesive Drape for Safer Removal in Negative Pressure Wound Therapy Applications.

NCT06717308 | Recruiting FDA Device

• 2 other identifiers: R44EB0362801R44EB036280-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 6

Brief Summary

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.), or other facility standard drape, 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, Weill Cornell Medical Center, and Absolute 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 Reduced nursing time by ≥20% Economic value through time and cost savings 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, Vital Medical Research, and All South Bay Footcare. Patients will undergo approximately three NPWT drape changes per week. Milestones: Demonstrate statistically significant (α=0.05) improvement over V.A.C./or standard 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 at final removal, qualitative data from clinicians will be collected to assess the acceptability and usability of Comfort Release® NPWT drapes.

Conditions

Frequency and Type of Medical Adhesive-Related Skin Injury; Clinician Acceptability of New NPWT Drape; Patient Drop-out Rate From Prescribed NPWT Treatment; Pain Assessment During Medical Adhesive Drape Removal; NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate)

Keywords

Medical Adhesive-Related Skin Injury (MARSI); pain with adhesive medical products; wound care; NPWT drape; Negative Pressure Wound Therapy; Surgical Drapes

Outcome Measures

Primary Outcomes (5)

• Incidence of Medical Adhesive-Related Skin Injury (MARSI).

  Measure: The percentage of patients experiencing Medical Adhesive-Related Skin Injury from surgical drape removal as assessed using the MARSI scale upon drape removal, and, if any abnormality is noted, a second MARSI assessment is completed. If there is a MARSI score of 1 or 2 = follow up assessment in completed in approximately 15 minutes, and a score of 3 or 4 = follow up assessment is completed in approximately 30 minutes.

  From the first drape removal to the end of treatment- 1 to 8 weeks.

• Patient-reported pain scores during drape removal.

  Pain intensity scored on the Indiana Polyclinic Combined Pain Scale during the drape removal. Scale of 0 to10, 0 = no pain and 10= worst imaginable pain.

  From enrollment to the end of treatment - from 1 - 8 weeks.

• Change in medication use for anxiety, pain, and stress.

  Measure: Quantity (e.g., dosage or frequency) of medications used for anxiety, pain, and stress related to drape removal.

  From enrollment to the end of treatment - from 1 - 8 weeks.

• Drape seal integrity (leak incidence rate).

  Proportion of drapes maintaining an effective seal compared to or the control drape.

  From enrollment to the end of treatment - from 1 - 8 weeks.

• Patient drop-out rate from NPWT treatment due to drape issues.

  Measurement: Percentage of patient who discontinue NPWT treatment before completing the prescribed treatment duration drop-out from the prescribed treatment duration to determine how much pain and skin injury plays a role in patient compliance.

  From enrollment to the end of treatment - from 1 - 8 weeks.

Secondary Outcomes (1)

• Clinician Acceptability of Comfort Release® drape.

  From application of the first drape to the end of treatment - from 1 - 8 weeks.

Study Arms (2)

Single use post surgical NPWT drape application

ACTIVE COMPARATOR

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.

Device: Comfort Release® NPWT drape

Multi-use chronic wound NPWT drape application

ACTIVE COMPARATOR

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, Vital Medical Research under Deeza Frankel, DPM, and All South Bay Footcare under Albert A. Elhiani, DPM. All patients will undergo 3 NPWT drape changes per week. Patients will be randomized to control (V.A.C. or standard 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 or standard drape and 1/2 to receive the intervention- Comfort Release drape. The intervention is a change in a component in the NPWT treatment kit.

Device: Comfort Release® NPWT drape

Interventions

Comfort Release® NPWT drape DEVICE

Comfort Release® NPWT drape- painless and trauma-free removal, as compared to the control NPWT drape.

Multi-use chronic wound NPWT drape application; Single use post surgical NPWT drape application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older post-surgical inpatients with a plan of treatment using NPWT
• Able to communicate and consent to participation in the study
• Access to V.A.C. by KCI drape and NPWT kits
• Able to report pain level using a pain scale.
• If outpatient- able to return to the clinic for all drape/dressing changes

You may not qualify if:

• History of known hypersensitivity to acrylic adhesives
• History of known hypersensitivity to isopropyl alcohol
• The patient is expected to be unconscious during the drape removal/change
• NOTE: For the Weill Cornell Medicine site only: Patient is expected to be unconscious during ALL drape removal/changes.
• Under the age of 18 years 5. Unable to give consent, including a language barrier, unless an interpreter is readily available.

Sponsors & Collaborators

• Global Biomedical Technologies, LLC: lead
• Weill Medical College of Cornell University: collaborator
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator
• Columbia University: collaborator

Study Sites (6)

Eazy Foot & Ankle

Los Angeles, California, 90035, United States

NOT YET RECRUITING

All South Bay Footcare/Podiatry Group, Inc.

Torrance, California, 90505, United States

NOT YET RECRUITING

Absolute Medical Center, LLC

Miami, Florida, 33126, United States

RECRUITING

Vital Medical Research

Sweetwater, Florida, 33174, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

ACTIVE NOT RECRUITING

Weill Cornell Medical Center

New York, New York, 10065, United States

RECRUITING

Related Publications (13)

• The Indiana Polyclinic Combined Pain Scale. 2022. at https://www.painscale.com/article/the - indiana -polyclinic- combined - pain - scale .)

  BACKGROUND

• McNichol L, Lund C, Rosen T, Gray M. Medical adhesives and patient safety: state of the science: consensus statements for the assessment, prevention, and treatment of adhesive-related skin injuries. J Wound Ostomy Continence Nurs. 2013 Jul-Aug;40(4):365-80; quiz E1-2. doi: 10.1097/WON.0b013e3182995516.

  PMID: 23759927 BACKGROUND

• Negative Pressure Wound Therapy Market Size, Share & Trends Analysis Report By Product (Conventional NPWT, Single- use NPWT), By Wound Type (Diabetic Foot Ulcers, Venous Leg Ulcers), By End Use, By Region, And Segment Forecasts, 2022 - 2030. 2022. (Accessed July 18, 2022, at https://www.grandviewresearch.com/industry - analysis/negative - pressure - wound - therapy - npwt - market .

  BACKGROUND

• Fumarola S, Allaway R, Callaghan R, Collier M, Downie F, Geraghty J, Kiernan S, Spratt F, Bianchi J, Bethell E, Downe A, Griffin J, Hughes M, King B, LeBlanc K, Savine L, Stubbs N, Voegeli D. Overlooked and underestimated: medical adhesive-related skin injuries. J Wound Care. 2020 Mar 1;29(Sup3c):S1-S24. doi: 10.12968/jowc.2020.29.Sup3c.S1. No abstract available.

  PMID: 32134695 BACKGROUND

• Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009 Nov-Dec;17(6):763-71. doi: 10.1111/j.1524-475X.2009.00543.x.

  PMID: 19903300 BACKGROUND

• National Health Statistic Report, Number 102, February 28, 2017

  BACKGROUND

• Apelqvist J, Willy C, Fagerdahl AM, Fraccalvieri M, Malmsjo M, Piaggesi A, Probst A, Vowden P. EWMA Document: Negative Pressure Wound Therapy. J Wound Care. 2017 Mar 1;26(Sup3):S1-S154. doi: 10.12968/jowc.2017.26.Sup3.S1. Erratum In: J Wound Care. 2018 Apr 2;27(4):253. doi: 10.12968/jowc.2018.27.4.253b.

  PMID: 28345371 BACKGROUND

• Zaver V, Marietta M, Kankanalu P. Negative Pressure Wound Therapy. 2026 Feb 21. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK576388/

  PMID: 35015413 BACKGROUND

• Robertson F, Wang Y, Rosing H. An oligomeric switch that rapidly decreases t he peel strength of a pressure-sensitive adhesive. International Journal of Adhesion and Adhesives 2014; 55:64-8

  BACKGROUND

• Upton D, Solowiej K, Hender C, Woodyatt KY. Stress and pain associated with dressing change in patients with chronic wounds. J Wound Care. 2012 Feb;21(2):53-4, 56,58 passim. doi: 10.12968/jowc.2012.21.2.53.

  PMID: 22584524 BACKGROUND

• Upton D, Andrews A. Pain and trauma in negative pressure wound therapy: a review. Int Wound J. 2015 Feb;12(1):100-5. doi: 10.1111/iwj.12059. Epub 2013 Mar 12.

  PMID: 23489350 BACKGROUND

• Vuerstaek JD, Vainas T, Wuite J, Nelemans P, Neumann MH, Veraart JC. State-of-the-art treatment of chronic leg ulcers: A randomized controlled trial comparing vacuum-assisted closure (V.A.C.) with modern wound dressings. J Vasc Surg. 2006 Nov;44(5):1029-37; discussion 1038. doi: 10.1016/j.jvs.2006.07.030. Epub 2006 Sep 26.

  PMID: 17000077 BACKGROUND

• Wang Y, Ameer GA, Sheppard BJ, Langer R. A tough biodegradable elastomer. Nat Biotechnol. 2002 Jun;20(6):602-6. doi: 10.1038/nbt0602-602.

  PMID: 12042865 BACKGROUND

Related Links

• Comfort Release® website.

Study Officials

• Howard S Rosing, MD, PhD

  Global Biomedical Technologies, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Howard S Rosing, Sponsor, MD, PhD

CONTACT

239-330-5646; hrosing@comfortrelease.com

Denise L Anderson, Director of Clinical Operations & Communications, RN, WCC

CONTACT

833-726-9269; danderson@comfortrelease.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 50% of the patients will receive the KCI® or standard drape (control), and 50% of the patients will receive the Comfort Release® drape (intervention). Outcomes assessed will include the effectiveness of the seal, pain during dressing removal, skin damage upon removal, and clinician acceptability.

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 5, 2024
• Study Start: February 10, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Jan 6, 2025
• Access Criteria: Health care professional status is required. All requests for access will be emailed to danderson@comfortrelease.com.

Locations

US (6)