Trials / Terminated
TerminatedNCT06306716
A Clinical Study on New Negative Pressure Wound Therapy Dressing in the Management of Chronic & Acute Wounds
A Clinical Evaluation of a New NPWT Dressing
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 7 (actual)
- Sponsor
- Smith & Nephew, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RENASYS Film with AIRLOCK Technology | RENASYS Film with AIRLOCK Technology intended for use with Smith+Nephew RENASYS NPWT Systems |
Timeline
- Start date
- 2024-05-30
- Primary completion
- 2025-10-31
- Completion
- 2025-10-31
- First posted
- 2024-03-12
- Last updated
- 2025-11-04
Locations
2 sites across 2 countries: Canada, Puerto Rico
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06306716. Inclusion in this directory is not an endorsement.