A novel collagen-based dressing to use in bleeding wounds
| ISRCTN | ISRCTN40313068 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40313068 |
| Integrated Research Application System (IRAS) | 325808 |
| Sponsor | Depletura Ltd |
| Funder | Depletura Ltd |
- Submission date
- 30/01/2026
- Registration date
- 13/02/2026
- Last edited
- 12/02/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
The occurrence of everyday accidental injury at home or work, road traffic collisions, as well as assaults and acts of violence or terrorism are a routine occurrence throughout the world. In addition, at any one time, there are armed conflicts taking place. Major trauma and uncontrolled bleeding are very significant factors in causing death to people who have been injured. The availability of fast-acting products able to bring about rapid cessation of bleeding (haemostasis) can be a major factor in preventing unnecessary blood loss, infection and deaths.
CLOTTA™ is a collagen-based dressing designed to stop bleeding, and it has been used successfully in veterinary medicine for a while now. However, we need to prove that it is safe for use in humans before it can be made widely available for use. Therefore, we have designed this study to provide evidence that CLOTTA™ is both safe and effective in the emergency department of a hospital.
Who can participate?
All patients who present at the Emergency Department of the Queen Elizabeth Hospital will be screened to see if they are eligible to take part. They need to be over the age of 18 years and have a bleeding wound which requires a dressing to control the bleeding.
What does the study involve?
We will use the CLOTTA™ dressing on patients who agree to taking part in the study following information read to them by one of the trial team. We will then stay with the patient for 10 minutes and observe the CLOTTA™ dressing to see if there is evidence of bleeding through the dressing. If this happens, we will record the time after application. After the dressing is removed, we will check the area for any reactions and also ask the patient about how comfortable it was. Some data will be collected then the patient’s participation in the study will be complete.
What are the possible benefits and risks of participating?
Collagen occurs naturally in the body, therefore the risks of use are low. However, it is possible that the patient may experience an allergic reaction because the dressing uses a poultry by-product. This is more likely if they have an existing allergy to meat products or eggs. As we are treating patients in a hospital with this dressing, any reaction like this can immediately be treated if it occurs.
We are unable to guarantee any direct benefit to participants that take part in this trial. Nonetheless, they will be contributing to an improved understanding of the control of bleeding wounds. The information gained from this trial will contribute to further studies and may help improve the treatment of people with similar injuries in the future.
Where is the study run from?
The Queen Elizabeth Hospital in Birmingham which is part of University Hospitals Birmingham NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
June 2026 to November 2027
Who is funding the study?
Depletura Ltd, the company who makes the dressing
Who is the main contact?
1. Hazel Smith, hazel.smith@uhb.nhs.uk
2. Dr Sarafina Vatharkar, sarafina.vatharkar@uhb.nhs.uk
Contact information
Principal investigator
Queen Elizabeth Hospital
Mindelsohn Way
Selly Oak
Birmingham
B15 2GW
United Kingdom
 ORCID ID |
0009-0005-2997-5316 |
|---|---|
| Phone | +44 (0)121 371 4242 |
| sarafina.vatharkar@uhb.nhs.uk |
Public
Queen Elizabeth Hospital
Mindelsohn Way
Birmingham
B15 2GW
United Kingdom
| ORCID ID |
0000-0002-7652-7699 |
|---|---|
| Phone | +44 (0)7789 933031 |
| hazel.smith@uhb.nhs.uk |
Scientific
Yorkshire House
219 St John Street
London
EC1V 4LY
United Kingdom
| Phone | +44 (0)7730 168070 |
|---|---|
| Patrick.Killoran@Depletura.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | N/A: single arm study | |
| Masking | Open (masking not used) | |
| Control | Uncontrolled | |
| Assignment | Single | |
| Purpose | Treatment | |
| Scientific title | A “first in human” clinical investigation study to determine the essential safety and performance of the CLOTTA™ haemostatic dressing in the control of actively bleeding wounds in trauma patients presenting to a Major Trauma Centre in the West Midlands | |
| Study acronym | CLOTTA | |
| Study objectives | 1. Safety as assessed by device related adverse events such as pain and local reactions 2. Performance assessed by time to haemostasis and occurrence of rebleeding (using the proxy of visual inspection of dressing) | |
| Ethics approval(s) |
Not yet submitted | |
| Health condition(s) or problem(s) studied | Patients with a single actively bleeding wound | |
| Intervention | A sterile, off-white, collagen dressing measuring 10 cm x 7.5 cm and 0.8 cm depth, presented in an easy-open, sealed foil pouch. The dressing can be applied directly to bleeding wounds to initiate clot formation and bleeding cessation. The dressing will be used along with a standard pressure bandage to keep it in place, according to standard clinical practice and procedures. No comparator is to be used. | |
| Intervention type | Device | |
| Phase | Phase I | |
| Drug / device / biological / vaccine name(s) | CLOTTA | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) | ||
| Completion date | 30/11/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Patients attending the Emergency Department at the Queen Elizabeth University Hospital, Birmingham 2. Aged 18 years and over 3. All actively bleeding wounds which require application of a dressing 4. Isolated injury only (single wound) |
| Key exclusion criteria | 1. Known allergy to any meat products or eggs 2. Pregnancy (known or apparent) 3. “Code Red” patients |
| Date of first enrolment | 01/06/2026 |
| Date of final enrolment | 31/05/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
12/02/2026: Study's existence confirmed by Depletura Ltd.
