Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-28 @ 2:15 AM
Study NCT ID:
NCT06700850
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2024-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Participant Study of Prototype Non-medicated Multilayer Foam Dressings on Intact Skin
Sponsor:
Smith & Nephew, Inc.
Organization:
Study Overview
Official Title:
An Open-label, Prospective, Comparative Human Participant Study to Evaluate the Clinically Acceptable Dressing Presence and Conformability Properties of Prototype Non-medicated Multilayer Foam Dressings Compared to Established Medical Devices
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate two new prototype non-medicated multilayer foam dressings on healthy, intact skin.
The study will find out how well two new prototype dressings stay in place as well as other dressing performance and safety factors when compared to corresponding, marketed dressings with a similar intended use profile and shape.
The study will compare:
1. Prototype dressing (rectangle) vs Marketed dressing (rectangle) on the knee.
2. Prototype dressing (square) vs Marketed dressing (square) on the thigh.
The main aim of the study is to show that the new prototype dressings are not worse than the established marketed comparison dressings in terms of staying in place on human participants at 7 days.
Dressings will have successfully stayed in place if the dressing edges have not lifted to reach the pad, and the pad is not exposed in any way.
Additional data will be collected to further support product performance up to 7 days, including safety information and potential device issues.
The study will find out how well two new prototype dressings stay in place as well as other dressing performance and safety factors when compared to corresponding, marketed dressings with a similar intended use profile and shape.
The study will compare:
1. Prototype dressing (rectangle) vs Marketed dressing (rectangle) on the knee.
2. Prototype dressing (square) vs Marketed dressing (square) on the thigh.
The main aim of the study is to show that the new prototype dressings are not worse than the established marketed comparison dressings in terms of staying in place on human participants at 7 days.
Dressings will have successfully stayed in place if the dressing edges have not lifted to reach the pad, and the pad is not exposed in any way.
Additional data will be collected to further support product performance up to 7 days, including safety information and potential device issues.
Detailed Description:
This is a single-centre, prospective, open-label, comparative, interventional study with intra-individual comparison.
Four different dressings (two prototype investigational medical devices (IMDs) and two comparators) will be investigated, with each participant receiving all dressings. The dressings will be divided into two comparison pairs:
(i) Prototype dressing (rectangle) vs Marketed dressing (rectangle) (ii) Prototype dressing (square) vs Marketed dressing (square)
Comparison pair (i) will be applied to the knees (one dressing per knee) and comparison pair (ii) will be applied to the thighs (one dressing per thigh). The two dressing in each comparison pair will be randomised to either the right or left knee / thigh in a 1:1 ratio.
120 participants will be recruited into this study at a single, Germany-based site. The sample size accounts for the required 105 evaluable participants and approximately 10% lost to follow-up rate. Participants will be in good general health and have intact skin.
Duration of the study will be 7-14 days, with participants attending 5 site visits. Screening can be completed on Day 0 or at a separate visit up to 7 days prior to Day 0. Dressings will be worn by participants for up to 7 days.
A screening visit will be completed Day -7 to Day 0 to assess participant eligibility and to perform informed consent. Objective and subjective assessments during visits will evaluate dressing performance and conformability properties. On Day 0, dressings will be applied after appropriate skin assessments. On Day 1, 3 and 7, assessments will include acceptable dressing presence, retention, pad integrity, pad lift, border lift, and dressing comfort. On Day 1, the assessments will be performed before and after a physiotherapy regime to evaluate dressing performance following mobilization of the leg/knee joint. On Day 7 or at dressing removal, additional assessments will include adhesive offset on skin, ease of removal and pain on removal. At each visit, photographs of the dressings will be taken. Furthermore, at each visit the skin at the application site will be assessed for any Adverse Events (AE) and the dressings assessed for Device Deficiencies.
Four different dressings (two prototype investigational medical devices (IMDs) and two comparators) will be investigated, with each participant receiving all dressings. The dressings will be divided into two comparison pairs:
(i) Prototype dressing (rectangle) vs Marketed dressing (rectangle) (ii) Prototype dressing (square) vs Marketed dressing (square)
Comparison pair (i) will be applied to the knees (one dressing per knee) and comparison pair (ii) will be applied to the thighs (one dressing per thigh). The two dressing in each comparison pair will be randomised to either the right or left knee / thigh in a 1:1 ratio.
120 participants will be recruited into this study at a single, Germany-based site. The sample size accounts for the required 105 evaluable participants and approximately 10% lost to follow-up rate. Participants will be in good general health and have intact skin.
Duration of the study will be 7-14 days, with participants attending 5 site visits. Screening can be completed on Day 0 or at a separate visit up to 7 days prior to Day 0. Dressings will be worn by participants for up to 7 days.
A screening visit will be completed Day -7 to Day 0 to assess participant eligibility and to perform informed consent. Objective and subjective assessments during visits will evaluate dressing performance and conformability properties. On Day 0, dressings will be applied after appropriate skin assessments. On Day 1, 3 and 7, assessments will include acceptable dressing presence, retention, pad integrity, pad lift, border lift, and dressing comfort. On Day 1, the assessments will be performed before and after a physiotherapy regime to evaluate dressing performance following mobilization of the leg/knee joint. On Day 7 or at dressing removal, additional assessments will include adhesive offset on skin, ease of removal and pain on removal. At each visit, photographs of the dressings will be taken. Furthermore, at each visit the skin at the application site will be assessed for any Adverse Events (AE) and the dressings assessed for Device Deficiencies.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CIV-24-03-046336 | OTHER | EUDAMED | View |