A Clinical Study on New Negative Pressure Wound Therapy Dressing in the Management of Chronic & Acute Wounds

NCT06306716 | Terminated FDA Device

• 1 other identifier: LEO.2021.10
• Study Type: observational
• Target: 7
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of the study is to evaluate the clinical performance of a new Negative Pressure Wound Therapy dressing in the management of chronic and acute wounds.

Conditions

Chronic Wounds; Acute Wounds

Keywords

Negative Pressure Wound Therapy (NPWT) Dressing; RENASYS Film with AIRLOCK Technology; Chronic and acute wounds

Outcome Measures

Primary Outcomes (1)

• Wound Healing Status

  Progression of wound healing will be assessed by the treating clinician and compared to the wound at treatment Day 0 (baseline) by recording on a 4-point Likert scale as: * "Wound healed" * "Wound progressing to healing" * "Wound static" * "Wound deteriorating" Any subject responding within the 2 categories of "Wound healed" or "Wound progressing to healing" will be considered a success.

  End of treatment period, up to 3 weeks

Secondary Outcomes (5)

• Percentage Reduction in Wound Volume from Baseline to Week 3

  Day 0, 1, 2, and 3 Weeks

• Percentage Reduction in Wound Area from Baseline to Week 3

  Day 0, 1, 2, and 3 Weeks

• Percentage Reduction in Wound depth from Baseline to Week 3

  Day 0, 1, 2, and 3 Weeks

• Percentage Area of Wound Bed Covered with Granulation Tissue

  Day 0, 1, 2, and 3 Weeks

• Peri-wound Pain Scores at Dressing Removal

  Day 0, 1, 2, and 3 Weeks

Study Arms (1)

Chronic and acute wounds

Subjects hospitalized due to chronic and acute wounds

Device: RENASYS Film with AIRLOCK Technology

Interventions

RENASYS Film with AIRLOCK Technology DEVICE

RENASYS Film with AIRLOCK Technology intended for use with Smith+Nephew RENASYS NPWT Systems

Also known as: RENASYS Dressing

Chronic and acute wounds

Eligibility Criteria

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

Study Population

This study aims to enroll up to 42 subjects from clinical sites in the United States and Canada with appropriate wound types including: * Chronic\* (this may include DFUs, VLUs, Pressure Ulcers but this is not an exhaustive list) * Acute (this may include traumatic and dehisced surgical wounds and partial thickness burns, but this is not an exhaustive list) \*Chronic wound in this study is defined as any wound of less than three months duration that is not healing after thirty (30) days of standard care and having addressed the underlying cause. As this is a pilot study, there are no limits to the inclusion of any particular wound type (chronic or acute) or inpatient/outpatient care at time of enrollment. Patients must be able to attend follow-up visits in clinic if they are receiving outpatient care.

You may qualify if:

• Subject has provided written informed consent.
• Subject is 18 years of age or over.
• Subject is able and willing to comply with study requirements.
• Subject is suitable to participate in the study in the opinion of the Investigator. .
• Subject has a wound(s) that, per Instructions for Use (IFU), is indicated and suitable for management with NPWT and fits one of the following wound types: a. Chronic\* (this may include Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Pressure Ulcers but this is not an exhaustive list) b. Acute (this may include traumatic and dehisced surgical wounds and partial thickness burns) \*Chronic wound(s) in this study is defined as any wound of less than three months duration that is not healing after thirty (30) days of standard care and having addressed the underlying cause
• Subject's wound to be treated is of a size that can be managed with one of the available sizes of the study device

You may not qualify if:

• Subject has hypersensitivity to the use of the RENASYS NPWT System or its components, or a contraindication per the IFU such as: a. exposed arteries, veins, organs, or nerves b. necrotic tissue with eschar present (unless adequately debrided) c. non-enteric and unexplored fistulas d. exposed anastomotic site e. malignancy in the wound
• Subject participation in the treatment period of another clinical trial within thirty (30) days of baseline visit or during the study.
• Subject has skin features (e.g., tattoos, pre-existing scarring, etc.) which in the opinion of the investigator will interfere with the study assessments.
• For lower extremity wounds\*\*, any subject with a wound on a limb with an inadequate arterial supply confirmed by one of the following within 14 days of treatment:
• Ankle Brachial Index (ABI) \<0.7
• Toe Brachial Index (TBI) \<0.5
• Great toe pressure \<40mmHg
• Abnormal triphasic or biphasic waveform patterns at the ankle \*\*This criteria is not applicable for patients having an above, or below knee amputation.
• Subject has had the target wound for greater than three months.
• Subject has a target wound that measures \<3 millimeters (mm) in maximum depth.
• Subject has untreated osteomyelitis
• Subject has active, untreated soft tissue infection.
• Subject has wounds that has been managed with NPWT in the previous four (4) weeks
• Subject has participated previously in this clinical trial.
• Subject has a history of poor compliance with medical treatment.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (2)

Lawson Health Research Institute

London, Ontario, N6C 2R5, Canada

Location

Wound Care Plus Research and Education Center

San Juan, PR, 00918, Puerto Rico

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Thomas Baboolal

  Smith & Nephew, Inc.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 12, 2024
• Study Start: May 30, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: November 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); CA (1)