Clinical trial NCT06306716: A Clinical Study on New Negative Pressure Wound Therapy Dressing in the Management of Chronic & Acute Wounds
Official title: A Clinical Evaluation of a New NPWT Dressing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Wounds
Acute Wounds
Keywords: Negative Pressure Wound Therapy (NPWT) Dressing
RENASYS Film with AIRLOCK Technology
Chronic and acute wounds
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-12
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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 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

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 inadequate arterial supply confirmed by one of the following within 14 days of treatment:

  1. Ankle Brachial Index (ABI) \<0.7
  2. Toe Brachial Index (TBI) \<0.5
  3. Great toe pressure \<40mmHg
  4. Abnormal triphasic or biphasic waveform patterns at the ankle \*\*This criteria is not applicable for patients having an above, or below knee amputation.
* 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 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.

Primary outcomes:
measure: Wound Healing Status
timeFrame: End of treatment period, up to 3 weeks
Secondary outcomes:
measure: Percentage Reduction in Wound Volume from Baseline to Week 3
timeFrame: Day 0, 1, 2, and 3 Weeks
measure: Percentage Reduction in Wound Area from Baseline to Week 3
timeFrame: Day 0, 1, 2, and 3 Weeks
measure: Percentage Reduction in Wound depth from Baseline to Week 3
timeFrame: Day 0, 1, 2, and 3 Weeks
measure: Percentage Area of Wound Bed Covered with Granulation Tissue
timeFrame: Day 0, 1, 2, and 3 Weeks
measure: Peri-wound Pain Scores at Dressing Removal
timeFrame: Day 0, 1, 2, and 3 Weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
Study officials:
affiliation: Smith & Nephew, Inc.
name: Thomas Baboolal
role: STUDY_CHAIR
References: