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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.
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exufiber | Experimental | This is an open, non-randomised , single arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exufiber | Device | Wound dressed with Exufiber for up to 21 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in wound progress | Wound progress compared between each visit up to final visit and assessed as:
| Day 14(-1 day), Day 21(+-1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in wound progress | Wound progress compared between baseline and final visit up to 14 days and assessed as:
| Day 14(-1 day) |
| Wound healing progress |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linköping University Hospital /Department of Hand and Plastic Surgery & Burn Center | Linköping | Sweden |
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Single group of patients
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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:
Exudate type:
| 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:
| 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:
| 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 :
| 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:
| 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 |