Surgical Drape With an Atraumatic Acrylic Adhesive for Negative Pressure Wound Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 9
- 主要终点
- Incidence of Medical Adhesive-Related Skin Injury (MARSI).
研究概览
简要总结
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 or short-term 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.
详细描述
Study Overview: Two-Aimed NPWT Drape Clinical Trial
Global Biomedical Technologies is advancing a novel surgical drape for negative pressure wound therapy (NPWT) that leverages Comfort Release®-a "switchable adhesive" technology designed for painless and trauma-free removal. This innovative adhesive incorporates oligo(glycerol sebacate) (OGS) and polyacrylate, allowing strong bonding during use and rapid release upon exposure to isopropyl alcohol (IPA). This product addresses the unmet need for effective NPWT adhesives that prevent medical adhesive-related skin injuries (MARSI) without compromising performance.
Key Features of Comfort Release® Adhesive:
- Composition: OGS, a biodegradable elastomer pre-polymer, forms hydrogen bonds with IPA, enabling adhesive release.
- Performance: A >70% drop in adhesive strength within 5 seconds of 70% IPA application.
- Benefits: Reduces pain and trauma at removal, maintains effective NPWT seals, and improves patient outcomes.
This Direct-to-Phase II study compares the Comfort Release® NPWT drape with the market leader, V.A.C. drape (KCI Technologies, Inc.), or standard drape, focusing on clinical performance, patient outcomes, and clinician feedback.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 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
排除标准
- •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
- •Unable to give consent, including a language barrier, unless an interpreter is readily available.
研究组 & 干预措施
Multi-use chronic wound NPWT drape application
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 of the NPWT treatment kit.
干预措施: Comfort Release® NPWT drape (Device)
Single or short-term use post-surgical NPWT drape application
Aim 1 description: A comparison of the 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 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, will be identical. Randomize patients- 1/2 of the patients to receive the 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.
干预措施: Comfort Release® NPWT drape (Device)
结局指标
主要结局
Incidence of Medical Adhesive-Related Skin Injury (MARSI).
时间窗: From the first drape removal to the end of treatment- 1 to 8 weeks.
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.
Patient-reported pain scores during drape removal.
时间窗: From enrollment to the end of treatment - from 1 - 8 weeks.
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.
Change in medication use for anxiety, pain, and stress.
时间窗: From enrollment to the end of treatment - from 1 - 8 weeks.
Measure: Quantity (e.g., dosage or frequency) of medications used for anxiety, pain, and stress related to drape removal.
Drape seal integrity (leak incidence rate).
时间窗: From enrollment to the end of treatment - from 1 - 8 weeks.
Proportion of drapes maintaining an effective seal compared to or the control drape.
Patient drop-out rate from NPWT treatment due to drape issues.
时间窗: From enrollment to the end of treatment - from 1 - 8 weeks.
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.
Incidence of Medical Adhesive-Related Skin Injury (MARSI).
时间窗: From the first drape removal to the end of treatment- 1 to 8 weeks.
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.
Patient-reported pain scores during drape removal.
时间窗: From enrollment to the end of treatment - from 1 - 8 weeks.
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.
Change in medication use for anxiety, pain, and stress.
时间窗: From enrollment to the end of treatment - from 1 - 8 weeks.
Measure: Quantity (e.g., dosage or frequency) of medications used for anxiety, pain, and stress related to drape removal.
Drape seal integrity (leak incidence rate).
时间窗: From enrollment to the end of treatment - from 1 - 8 weeks.
Proportion of drapes maintaining an effective seal compared to or the control drape.
Patient drop-out rate from NPWT treatment due to drape issues.
时间窗: From enrollment to the end of treatment - from 1 - 8 weeks.
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.
次要结局
- Clinician Acceptability of Comfort Release® drape.(From application of the first drape to the end of treatment - from 1 - 8 weeks.)