Acute Wounds, Chronic Wounds
Conditions
Keywords
Negative Pressure Wound Therapy (NPWT) Dressing, RENASYS Film with AIRLOCK Technology, Chronic and acute wounds
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.
Interventions
DEVICERENASYS Film with AIRLOCK Technology
RENASYS Film with AIRLOCK Technology intended for use with Smith+Nephew RENASYS NPWT Systems
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing Status | End of treatment period, up to 3 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Reduction in Wound Volume from Baseline to Week 3 | Day 0, 1, 2, and 3 Weeks | 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. |
| Percentage Reduction in Wound Area from Baseline to Week 3 | Day 0, 1, 2, and 3 Weeks | 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. |
| Percentage Reduction in Wound depth from Baseline to Week 3 | Day 0, 1, 2, and 3 Weeks | 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. |
| Percentage Area of Wound Bed Covered with Granulation Tissue | Day 0, 1, 2, and 3 Weeks | 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. |
| Peri-wound Pain Scores at Dressing Removal | Day 0, 1, 2, and 3 Weeks | 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. |
Countries
Canada, Puerto Rico
Outcome results
None listed