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

Chronic Wounds Clinical Trial

Official title:

A Single Centre Clinical Evaluation of a New NPWT Dressing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06306716
• Other study ID #: LEO.2021.10
• Status: Recruiting
• Start date: May 30, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: June 2024
• Source: Smith & Nephew, Inc.
• Contact: Mary Ozokwere
• Phone: +1 469-560-0727
• Email: Mary.Ozokwere[@]smith-nephew.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The primary objective is to evaluate the percentage of wounds progressing to healing at the end of the treatment period. The study will also evaluate the percentage of granulation tissue, pain experienced on dressing change and safety by way of incidence and nature of device-related or procedure-related Adverse Events and Device Deficiencies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 is an inpatient at time of enrollment and will be able to attend follow-up visits in clinic following discharge.

• Subject has a wound 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 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

Exclusion Criteria:

• 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 Ankle Brachial Index (ABI) <0.7

• Any subject that meets the definition of a Vulnerable Subject per ISO 14155 (i.e., individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response). Ethnic minorities will be included providing they meet other inclusion criteria.

• 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 previously 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.

• Pregnancy at time of enrolment.

• Subject has a medical or physical condition that in the opinion of the Investigator would preclude safe subject participation in the study.

Related Conditions & MeSH terms

• Acute Wounds
• Chronic Wounds
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Canada	Lawson Health Research Institute	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage Reduction in Wound Volume from Baseline to Week 3	Percentage reduction in wound volume as measured by imaging - day 0, weekly from week 1 to week 3 of treatment or to point of wound closure if that occurs first.	Day 0, 1, 2, and 3 Weeks
Secondary	Percentage Reduction in Wound Area from Baseline to Week 3	Percentage reduction in wound area as measured by imaging - day 0, weekly from week 1 to week 3 of treatment or to point of wound closure if that occurs first.	Day 0, 1, 2, and 3 Weeks
Secondary	Percentage Reduction in Wound depth from Baseline to Week 3	Percentage reduction in wound depth as measured by imaging - day 0, weekly from week 1 to week 3 of treatment or to point of wound closure if that occurs first.	Day 0, 1, 2, and 3 Weeks
Secondary	Percentage Area of Wound Bed Covered with Granulation Tissue	The percentage of the wound bed covered with granulation tissue will be summarised using continuous summary statistics at day 0, weeks 1, 2 and 3 for each wound type and overall.	Day 0, 1, 2, and 3 Weeks
Secondary	Peri-wound Pain Scores at Dressing Removal	Pain scores on removal of the dressing specifically from the peri-wound skin will be assessed using a 0-100 Visual Analog Scale (VAS) scale, with zero (0) indicating no pain and 100 indicating the worst possible pain.	Day 0, 1, 2, and 3 Weeks