A novel collagen-based dressing to use in bleeding wounds

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN40313068

Enrollment

Registered

2026-02-13

Start date

2026-09-01

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with a single actively bleeding wound Injury, Occupational Diseases, Poisoning

Interventions

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 clo

Eligibility

Sex/Gender

All

Age

18 Years to 120 Years

Inclusion criteria

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)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Cessation of bleeding measured using strike-through of trial dressing at up to 10 minutes	—

Countries

England, United Kingdom

Contacts

Public ContactHazel Smith

hazel.smith@uhb.nhs.uk+44 (0)7789 933031

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026