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
Patients with a single actively bleeding wound
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.
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)
Current key exclusion criteria as of 22/06/2026: 1. Known allergy to any meat products or eggs 2. Pregnancy (known or suspected) 3. “Code Red” patients (a critical, high level emergency medical response activated for patients with severe, life threatening bleeding due to major trauma) _____ Previous key exclusion criteria: 1. Known allergy to any meat products or eggs 2. Pregnancy (known or apparent) 3. “Code Red” patients