Acute WoundExuDS01NCT04884568
Confirm Performance and Safety of Exufiber When Used as Intended on Donor Sites
A study testing Exufiber in people with Acute Wound and Donor Site, run by Molnlycke Health Care AB at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Wound, Donor Site, Split Skin Graft
- What is being tested?
- Exufiber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSweden
- Study dates
- 16 Nov 2021to 9 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male ≥18 years old.
- Scheduled for a split skin graft transplantation of a partial thickness graft at a healthy and intact location at the thigh.
- Planned hospitalization for at least 3 days post-transplantation.
- Size of donor site treatable with an 15cm x 15cm Exufiber, with 2-3 cm additional overlap to dry surrounding skin.
- Provision of written informed consent
Who cannot join
- Burn injury of ≥20% of total body surface area.
- Diagnosed with paraplegia.
- Harvested graft from the same donor site location before.
- Donor sites not to be harvested with dermatome
- Pregnancy or lactation at the time of screening.
- Known allergy/hypersensitivity to Exufiber, Mepilex or other components/products used in this investigation.
Show all 9Show fewer
- Participating in other ongoing clinical investigation that may impact the outcome of this investigation based on the judgement of the investigator.
- Not able to read or understand Swedish.
- Any other conditions that according to the investigator may make follow-up or investigation inappropriate.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Linköping University Hospital /Department of Hand and Plastic Surgery & Burn Center
Linköping
About this study
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
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.
Read the 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
- Conditions
- Acute Wound, Donor Site, Split Skin Graft
- Being tested
- Exufiber
- Keywords
- Post Market Clinical Follow-up, Exufiber, Gelling fibre dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExufiberDevice
Wound dressed with Exufiber for up to 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Exufiber | Experimental | This is an open, non-randomised , single arm study Receives: Device: Exufiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wound progress
Wound progress compared between each visit up to final visit and assessed as:
- Deteriorated
- No change
- Improved
Measured: Day 14(-1 day), Day 21(+-1 day)
Secondary outcomes (23)
Change in wound progress
Wound progress compared between baseline and final visit up to 14 days and assessed as:
- Deteriorated
- No change
- Improved
Measured: 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.
Measured: 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.
Measured: Day 21(+-1 day)
Wound size
Wound dimension/size assessed as area using following assessments:
Width (mm) Length (mm)
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 dressing
- Very Poor
- Poor
- Good
- Very Good
- N/A
- Experience during dressing change
- Very Poor
- Poor
- Good
- Very Good
- N/A
- Overall impression of the dressing
- Very Poor
- Poor
- Good
- Very Good
- N/A
Measured: 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
Measured: 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.
Measured: 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.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start16 Nov 2021
- Primary completion9 May 2023
- Study completion9 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group of patients
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884568
- Sponsor's protocol ID
- ExuDS01
- Acronym
- ExuDS01
- Status last verified
- Sep 2023
- First submitted
- 7 May 2021
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04884568
- Acronym / sponsor ID
- ExuDS01 / ExuDS01
- Conditions
- Acute Wound, Donor Site, Split Skin Graft
- Keywords
- Post Market Clinical Follow-up, Exufiber, Gelling fibre dressing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group of patients
| Arm | Type | Receives |
|---|---|---|
| Exufiber | Experimental | Device: ExufiberThis is an open, non-randomised , single arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female or male ≥18 years old.
- Scheduled for a split skin graft transplantation of a partial thickness graft at a healthy and intact location at the thigh.
- Planned hospitalization for at least 3 days post-transplantation.
- Size of donor site treatable with an 15cm x 15cm Exufiber, with 2-3 cm additional overlap to dry surrounding skin.
- Provision of written informed consent
Key exclusion criteria (9 listed)
- Burn injury of ≥20% of total body surface area.
- Diagnosed with paraplegia.
- Harvested graft from the same donor site location before.
- Donor sites not to be harvested with dermatome
- Pregnancy or lactation at the time of screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExufiberWound dressed with Exufiber for up to 21 days. | Device | Exufiber |
Primary outcome
Change in wound progress
Time frame: Day 14(-1 day), Day 21(+-1 day)
Wound progress compared between each visit up to final visit and assessed as: * Deteriorated * No change * Improved
23 secondary outcomes
Change in wound progress
Time frame: Day 14(-1 day)
Wound healing progress
Time frame: Day 14(-1 day), Day 21(+-1 day)
Follow-up assessment of wound healing when treated according to clinical praxis
Time frame: Day 21(+-1 day)
Wound size
Time frame: Day 14(-1 day)
Change in exudate amount and type
Time frame: Day 14(-1 day), Day 21(+- 1 day)
Local infection
Time frame: Day 14(-1 day), Day 21(+- 1 day)
Subject's pain
Time frame: Day 14(-1 day), Day 21(+- 1 day)
Subject's itching
Time frame: Day 14(-1 day), Day 21(+- 1 day)
Ability of dressing to absorb blood
Time frame: Day 21(+-1 day)
Ability of dressing to absorb exudate
Time frame: Day 21(+-1 day)
Ability of dressing to retain exudate
Time frame: Day 21(+- 1 day)
Ability of the dressing to retain blood
Time frame: Day 21(+- 1 day)
Exudate leakage
Time frame: Day 21(+- 1 day)
Blood leakage
Time frame: Day 21(+- 1 day)
Ability of dressing to stay in place
Time frame: Day 21(+- 1 day)
Ease of handling
Time frame: Day 21(+-1 day)
Ease of dressing removal
Time frame: Day 21(+- 1 day)
Dressing conformability
Time frame: Day 21(+- 1 day)
Dressing integrity
Time frame: Day 21(+- 1 day)
Comfort and experience
Time frame: Day 21(+-1 day)
Subject's quality of life assessment
Time frame: Day 21(+- 1 day)
Dressing wear time
Time frame: Day 3, Day 14(-1 day), Day 21(+- 1 day)
pH level measurement
Time frame: Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exufiber in people with Acute Wound and Donor Site, run by Molnlycke Health Care AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in wound progress (time frame: Day 14(-1 day), Day 21(+-1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.