Confirm Performance and Safety of Exufiber When Used as Intended on Donor Sites (ExuDS01)

An Open, Non-comparative, Post-market Clinical Follow-up Investigation to Confirm Performance and Safety of Exufiber When Used as Intended on Donor Sites

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.

Study Overview

• Status: Completed
• Conditions: Acute Wound; Donor Site; Split Skin Graft
• Intervention / Treatment: Device: Exufiber

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

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden
    • Linköping University Hospital /Department of Hand and Plastic Surgery & Burn Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female or male ≥18 years old.
2. Scheduled for a split skin graft transplantation of a partial thickness graft at a healthy and intact location at the thigh.
3. Planned hospitalization for at least 3 days post-transplantation.
4. Size of donor site treatable with an 15cm x 15cm Exufiber, with 2-3 cm additional overlap to dry surrounding skin.
5. Provision of written informed consent

Exclusion Criteria:

1. Burn injury of ≥20% of total body surface area.
2. Diagnosed with paraplegia.
3. Harvested graft from the same donor site location before.
4. Donor sites not to be harvested with dermatome
5. Pregnancy or lactation at the time of screening.
6. Known allergy/hypersensitivity to Exufiber, Mepilex or other components/products used in this investigation.
7. Participating in other ongoing clinical investigation that may impact the outcome of this investigation based on the judgement of the investigator.
8. Not able to read or understand Swedish.
9. Any other conditions that according to the investigator may make follow-up or investigation inappropriate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exufiber; This is an open, non-randomised , single arm study	Device: Exufiber; Wound dressed with Exufiber for up to 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in wound progress	Wound progress compared between each visit up to final visit and assessed as: Deteriorated; No change; Improved	Day 14(-1 day), Day 21(+-1 day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in wound progress	Wound progress compared between baseline and final visit up to 14 days and assessed as: Deteriorated; No change; Improved	Day 14(-1 day)
Wound healing progress	Wound healing progress will be assessed between baseline and final visit and assesed as: - Rating percentage (%) re-epithelialisation using a visual score (0-100%). 0% is equal to no re-epithelialisation and 100% is equal to fully re-epithelialised.	Day 14(-1 day), Day 21(+-1 day)
Follow-up assessment of wound healing when treated according to clinical praxis	Wound healing progress for subjects treated according to clinical praxis when wound is not healed and not treatable with Exufiber (dry wound) will be followed up at the final visit and assessed as: - Rating percentage (%) re-epithelialisation using a visual score (0-100%). 0% is equal to no re-epithelialisation and 100% is equal to fully re-epithelialised.	Day 21(+-1 day)
Wound size	Wound dimension/size assessed as area using following assessments: Width (mm) Length (mm)	Day 14(-1 day)
Change in exudate amount and type	Evaluation of the amount of wound exudate and the exudate type at each follow-up visit using the variables below: Exudate amount: High; Moderate; Low; None Exudate type: Serous; Serousanguinous; Sanguinous; Purulent; N/A	Day 14(-1 day), Day 21(+- 1 day)
Local infection	Presence of signs of local wound infection determined at each follow-up visit, using the variables listed below: Swelling; Redness; Heat; Fever; Pain; Foul odour	Day 14(-1 day), Day 21(+- 1 day)
Subject's pain	Subject's pain captured using a numeric rating scale(NRS) at each follow-up visit where the patient verbally grade his/her pain on a level from 0 to 10, where 0 indicates no pain and 10 the worst imaginable pain for the subject. The NRS will be used at the following occasions: Pain before dressing removal; Pain when removing Mepilex (secondary dressing); Pain when removing Exufiber	Day 14(-1 day), Day 21(+- 1 day)
Subject's itching	Subject's itching captured at each follow-up visit using the NRS scale where the patient verbally grade their itching on a level from 0 to 10, where 0 indicates no itching and 10 the worst imaginable itching for the subject. The subject will answer the NRS question, about itching intensity, just before dressing removal.	Day 14(-1 day), Day 21(+- 1 day)
Ability of dressing to absorb blood	A subjective measurement captured at the final visit to assess performance of the primary and secondary dressing and their ability to absorb blood using the variables below: Very poor Poor Good Very good N/A	Day 21(+-1 day)
Ability of dressing to absorb exudate	A subjective measurement captured at the final visit to assess performance of the primary and secondary dressing and their ability to absorb exudate using the variables below: Very poor Poor Good Very good N/A	Day 21(+-1 day)
Ability of dressing to retain exudate	A subjective measurement captured at the final visit to asses performance of the primary and secondary dressing and its ability to retain exudate using the variables below: Very poor Poor Good Very good N/A	Day 21(+- 1 day)
Ability of the dressing to retain blood	A subjective measurement captured at the final visit to assess performance of the primary and secondary dressing and their ability to retain blood using the variables below: Very poor Poor Good Very good N/A	Day 21(+- 1 day)
Exudate leakage	A subjective measurement captured at the final visit to assess performance of the primary and secondary dressing in regards to exudate leakage, using the variables below: Major Minor None N/A	Day 21(+- 1 day)
Blood leakage	A subjective measurement captured at the final visit to assess performance of the primary and secondary dressing in regards to blood leakage, using the variables below: Major Minor None N/A	Day 21(+- 1 day)
Ability of dressing to stay in place	A subjective measurement captured at the final visit to assess performance of the primary and secondary dressing and their ability to stay in place, using the variables listed below: Very poor Poor Good Very good N/A	Day 21(+- 1 day)
Ease of handling	A subjective measurement captured at the final visit to assess the handling of the primary dressing and ease of dressing application, using the variables listed below: Very poor Poor Good Very good N/A	Day 21(+-1 day)
Ease of dressing removal	A subjective measurement captured at the final visit to assess the ease of removal of the primary dressing, using the variables listed below: Very poor Poor Good Very good N/A	Day 21(+- 1 day)
Dressing conformability	A subjective measurement captured at the final visit to assess performance of the primary dressing and its ability to conform, using the variables listed below: Very poor Poor Good Very good N/A	Day 21(+- 1 day)
Dressing integrity	A subjective measurement captured at the final visit to assess performance of the primary dressing and its ability to maintain integrity by being removed in one piece, using the variables below: Very poor Poor Good Very good N/A	Day 21(+- 1 day)
Comfort and experience	The subject's perception of comfort and experience of the primary dressing will be captured at the final visit by asking questions to the subject : Comfort during wear of the dressingVery PoorPoorGoodVery GoodN/A; Experience during dressing changeVery PoorPoorGoodVery GoodN/A; Overall impression of the dressingVery PoorPoorGoodVery GoodN/A	Day 21(+-1 day)
Subject's quality of life assessment	Impact of everyday life will be captured at the final visit through a NRS scale where the subject will grade how much the treatment has affected the his/her daily life. 0 is equal to no influence and 10 to considerable influence on everyday life or unbearable. If replying >0, the subject will state the presence or absence of the following causes: Leakage of dressing; Impaired mobility; Difficulties in getting dressed; Pain; Odor	Day 21(+- 1 day)
Dressing wear time	Dressing wear time of the primary and secondary dressings will be captured in a Dressing log from baseline until final visit including unscheduled extra visits.	Day 3, Day 14(-1 day), Day 21(+- 1 day)
pH level measurement	Levels of pH in the wound bed will be captured if it is deemed necessary to change both primary and secondary dressings, using pH indicator paper sticks.	Day 3

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Actual): May 9, 2023
• Study Completion (Actual): May 9, 2023

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: May 7, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Post Market Clinical Follow-up; Exufiber; Gelling fibre dressing
• Other Study ID Numbers: ExuDS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No