A prospective study using the KerraCel™ dressing on multiple wound types
| ISRCTN | ISRCTN33932204 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33932204 |
| IRAS number | 288315 |
| Secondary identifying numbers | KERA_CEL-PMCF007, IRAS 288315, CPMS 47700 |
- Submission date
- 15/09/2021
- Registration date
- 15/11/2021
- Last edited
- 24/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
The KerraCel™ dressing is a CE-marked product that has been on the market since 2013. It contains gelling fibers that can soak up the fluid that can be created by wounds on the skin. The aim of the study is to collect additional information on the dressing to show that it is working as intended.
Who can participate?
Patients aged 22 years or older and being seen for these types of wounds: Oncology wounds, traumatic wounds, cavity wounds, skin donor site. Examples of these can be: Oncology - radiation burns, cancerous wounds or wounds that occur after surgical removal of cancer. Traumatic - abrasions (deep scrapes) or lacerations. Cavity - wounds in a cavity (such as addomen or chest). Donor sites where skin has been removed for grafting.
What does the study involve?
For patients who meet the requirements to participate, you will be seen 4 times in the office/clinic. On the first visit, you will have a picture taken of the wound and the dressing put over the wound. You will come in 2 additional times, approximately 7 days apart from each visit, to have another picture of the wound taken and another dressing placed over the wound. A final visit will occur (again approximately 7 days from the 3rd visit), where the dressing will be removed and another picture is taken. No surveys will be completed for this study and only small amounts of information such as medical history, medication use, and information about your wound will be collected.
What are the possible benefits and risks of participating?
Possible benefits of the study are the wound dressing may help manage your wound healing, additional follow-up by the staff at the hospital since this is a study, use of a dressing not currently in use at the facility.
Possible risks of participating are the same risks that would occur for treating any open wound with a wound dressing: skin irritation, redness, possible infection, delay in wound healing. One possible risks for this type of dressing is some of the gel material could remain in the wound.
Where is the study run from?
Wythenshawe Hospital (UK)
When is the study starting and how long is it expected to run for?
April 2021 to June 2023
Who is funding the study?
KCI® USA, Inc (now a part of 3M) (USA)
Who is the main contact?
Mrs Lawrie Rogerson-Wynne, Lawrie.rogerson@mft.nhs.uk
Contact information
Public
Research Office, First floor, NIHR Research Building
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9QZ
United Kingdom
| Phone | +44 (0)161 291 4850 |
|---|---|
| Lawrie.rogerson@mft.nhs.uk |
Scientific
KCI USA, Inc.
6203 Farinon Drive
San Antonio
78249
United States of America
| Phone | +1 5126625943 |
|---|---|
| esynatschk@mmm.com |
Study information
| Study design | Single center observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | A prospective, observational, Post Market Clinical Follow-up (PMCF) study in patients using 3M™ KerraCel™ Gelling Fiber dressing |
| Study objectives | Current hypothesis as of 18/03/2022: The aim of this study is to describe the population and indications of the KerraCel™ Dressing to demonstrate that the product is performing as expected and is safe specifically on the identified wound types, where it has been identified that additional evidence is needed to support the Clinical Evaluation Report (CER). _____ Previous hypothesis: The aim of this study is to describe the population and indications of the KerraCel™ Dressing to demonstrate that the product is performing as expected and is safe specifically on oncological and traumatic wounds, where it has been identified that additional evidence is needed to support the Clinical Evaluation Report (CER). |
| Ethics approval(s) | Approved 23/04/2021, London-Westminster Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8388; westminster.rec@hra.nhs.uk), ref: 21/PR/0337 |
| Health condition(s) or problem(s) studied | Oncological wounds (e.g. radiation burns, cancerous wounds and surgical wounds once the cancerous tissue has been removed), traumatic wounds (e.g. abrasions and lacerations), cavity wounds (such as abdominal or thoracic) and wounds created from skin donor sites |
| Intervention | Patients will be seen and evaluated by a clinician to determine if their wound is appropriate to be treated with the KerraCel™ dressing. If yes, the clinician will make general observations of the wound and then dress the wound. Pictures will be taken of the wound initially and at each dressing change. Patients will be seen 4 times in the office/clinic. On the first visit, a picture is taken of the wound and the dressing put over the wound. At 2 additional visits, approximately 7 days apart from each visit, another picture of the wound is taken and another dressing is placed over the wound. A final visit will occur (again approximately 7 days from the 3rd visit), where the dressing will be removed and another picture taken. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | 3M™ KerraCel™ Gelling Fiber Dressing |
| Primary outcome measure | Treatment-related adverse events measured using patient records up to the final visit (~21-28 days) |
| Secondary outcome measures | Wound healing and wound bed preparation by visual inspection of at baseline, ~day 7, 14, 21-28: 1. Decrease in wound size (volume, area, or depth) 2. Increase in % of wound granulation tissue 3. Wound moisture evaluation defined as wound exudate levels indicated as optimal 4. Decrease in % of nonviable tissue |
| Overall study start date | 23/04/2021 |
| Completion date | 21/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 22 Years |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 48 |
| Key inclusion criteria | Current inclusion criteria as of 18/03/2022: 1. Subjects who have been diagnosed with an oncological wound (e.g. radiation burns, cancerous wounds, and surgical wounds once the cancerous tissue has been removed), or traumatic wound (e.g. abrasions and lacerations), or cavity wound (wounds in a cavity) or skin donor site 2. Must be able to provide informed consent 3. Only one wound may be treated per subject for the study 4. Aged ≥22 years _____ Previous inclusion criteria: 1. Subjects who have been diagnosed with an oncological wound (e.g. radiation burns, cancerous wounds, and surgical wounds once the cancerous issue has been removed) or traumatic (e.g. abrasions and lacerations) wound. 2. Must be able to provide informed consent. 3. Only one wound may be treated per subject for the study. 4. Age ≥22 years. |
| Key exclusion criteria | Current exclusion criteria as of 18/03/2022: 1. Has a known allergy to the dressing material 2. Has a wound that has uncontrolled heavy bleeding 3. Wound or burn larger than 20 cm in any direction 4. Pregnant or breastfeeding _____ Previous exclusion criteria: 1. Has a wound that requires packing of a body cavity with the KerraCel™ dressing, per the manufacturer’s instructions for use. 2. Has a wound that has not achieved hemostasis, per the manufacturer’s instructions for use. 3. Wound or burn larger than 20cm in any direction. 4. Pregnant or breastfeeding. |
| Date of first enrolment | 01/09/2021 |
| Date of final enrolment | 09/06/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southmoor Road
Manchester
M23 9QZ
United Kingdom
Sponsor information
Industry
6203 Farinon Drive
San Antonio
78249
United States of America
| Phone | +1 800 275-4524 |
|---|---|
| esynatschk@mmm.com | |
| Website | https://www.acelity.com/ |
"ROR" |
https://ror.org/00wc6ay63 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Kinetic Concepts, Inc., KCI USA, KCI
- Location
- United States of America
Results and Publications
| Intention to publish date | 15/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | At this time, there is no plan to publish the data from this study. This data is intended to be post-market data to support the clinical evidence of the product. The final report is planned for 08/12/2022. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the researchers' intent not to publish the data in any journal article or for any business purposes. They will post the study results on the ISRCTN registry as required but that will be the extent of the data shared for this study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
24/07/2025: The intention to publish date was changed from 27/02/2025 to 15/09/2025.
29/01/2025: The intention to publish date was changed from 31/01/2025 to 27/02/2025.
28/11/2024: The intention to publish date was changed from 08/05/2024 to 31/01/2025. The results have been delayed due to an interest in independent analysis of the captured images. Once this has been completed, the report and results will be finalized.
25/03/2024: IPD sharing plan added.
19/03/2024: The intention to publish date has been changed from 29/03/2024 to 08/05/2024.
27/12/2023: The intention to publish date has been changed from 15/02/2024 to 29/03/2024.
15/09/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2023 to 09/06/2023.
2. The overall end date was changed from 30/09/2023 to 21/06/2023.
3. The plain English summary was updated to reflect these changes.
4. The total final enrolment was added.
5. The intention to publish date was changed from 15/12/2023 to 15/02/2024.
27/04/2023: The recruitment end date was changed from 29/06/2023 to 30/06/2023.
11/04/2023: The following changes have been made:
1. The recruitment end date has been changed from 20/04/2023 to 29/06/2023.
2. The overall trial end date has been changed from 15/07/2023 to 30/09/2023 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 15/10/2023 to 15/12/2023.
18/03/2022: The following changes have been made:
1. The public title has been changed from "A prospective study using the KerraCel™ dressing on cancerous and traumatic wounds" to "A prospective study using the KerraCel™ dressing on multiple wound types".
2. The scientific title has been changed from "A prospective, observational, Post Market Clinical Follow-up (PMCF) study in patients using KerraCel™ dressing on oncological and traumatic wounds" to "A prospective, observational, Post Market Clinical Follow-up (PMCF) study in patients using 3M™ KerraCel™ Gelling Fiber dressing".
3. The study hypothesis has been changed.
4. The overall trial end date has been changed from 01/09/2022 to 15/07/2023 and the plain English summary updated accordingly.
5. The condition has been changed from "Patients who are seen for oncological wounds (e.g. radiation burns, cancerous wounds and surgical wounds once the cancerous tissue has been removed) and traumatic (e.g. abrasions and lacerations) wounds" to "Oncological wounds (e.g. radiation burns, cancerous wounds and surgical wounds once the cancerous tissue has been removed), traumatic wounds (e.g. abrasions and lacerations), cavity wounds (such as abdominal or thoracic) and wounds created from skin donor sites".
6. The drug name has been changed from "KerraCel™ Dressing" to "3M™ KerraCel™ Gelling Fiber Dressing".
7. The participant inclusion criteria have been changed.
8. The participant exclusion criteria have been changed.
9. The target number of participants has been changed from 40 to 50.
10. The recruitment end date has been changed from 30/09/2022 to 20/04/2023.
11. The intention to publish date has been changed from 08/12/2022 to 15/10/2023.
12. The plain English summary has been updated to reflect these changes.
07/12/2021: Internal review.
28/09/2021: Trial's existence confirmed by London-Westminster Research Ethics Committee.
