Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-28 @ 5:27 PM
Study NCT ID:
NCT04884568
Status:
COMPLETED
Last Update Posted:
2023-09-08
First Post:
2021-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Confirm Performance and Safety of Exufiber When Used as Intended on Donor Sites
Sponsor:
Molnlycke Health Care AB
Organization:
Study Overview
Official Title:
An Open, Non-comparative, Post-market Clinical Follow-up Investigation to Confirm Performance and Safety of Exufiber When Used as Intended on Donor Sites
Status:
COMPLETED
Status Verified Date:
2023-09
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:
ExuDS01
Brief Summary:
This is a single-centre prospective, open, non-comparative, Post-Market Clinical Follow-up (PMCF) investigation to confirm performance and safety of Exufiber® (Gelling fibre dressing) when used as intended on donor sites through assessment of wound progression from baseline to the subject´s last visit.
Detailed Description:
A single-centre prospective, open, non-comparative, PMCF investigation to confirm performance and safety of Exufiber® (gelling fibre dressing) when used as intended on donor sites. The investigation will include eligible subjects undergoing split skin graft transplantation for harvesting of a partial-thickness skin graft, i.e. excision of the epidermis and part of the dermis. After the study inclusion (baseline) the patient will go through the split skin graft transplantation following application of the Exufiber® dressing, Mepilex®(non-border) dressing, and any third dressing as required on the donor site. Each subject will thereafter be followed up on days 3, 14, and 21 prior completion in the study.
A subject may complete the study prior to or on day 14 as well as in between day 14 and day 21 if the donor site is healed. Wound healing progression will be determined by the investigator/designee and assessed as:
* 100% re-epithelialisation including small residual scabs/blisters and open areas less than 1 cm within an otherwise fully re-epithelialised area, and/or
* less than 100% re-epithelialization but to the extent that the Exufiber dressing is not required anymore
If the donor site is not healed and the donor site is dry and therefor not treatable with Exufiber the patient will be treated according to clinical praxis and followed for outcomes on the following visits.
Approximately 34 eligible subjects will be included in one centre in Sweden.
The primary performance endpoint will be progression of donor site wound from baseline to last visit when Exufiber is used, up to 21 days.
Wound progression will be determined by the investigator/designee and will be assessed as one of the following three outcomes:
* Deteriorated
* No change
* Improved
A subject may complete the study prior to or on day 14 as well as in between day 14 and day 21 if the donor site is healed. Wound healing progression will be determined by the investigator/designee and assessed as:
* 100% re-epithelialisation including small residual scabs/blisters and open areas less than 1 cm within an otherwise fully re-epithelialised area, and/or
* less than 100% re-epithelialization but to the extent that the Exufiber dressing is not required anymore
If the donor site is not healed and the donor site is dry and therefor not treatable with Exufiber the patient will be treated according to clinical praxis and followed for outcomes on the following visits.
Approximately 34 eligible subjects will be included in one centre in Sweden.
The primary performance endpoint will be progression of donor site wound from baseline to last visit when Exufiber is used, up to 21 days.
Wound progression will be determined by the investigator/designee and will be assessed as one of the following three outcomes:
* Deteriorated
* No change
* Improved
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?:
None
Is an FDA AA801 Violation?: