External use of tranexamic acid to improve wound healing

Phase 1

• Conditions: Immunomodulation of postoperative inflammatory reactions and therebyreduction of wound fluid production and improved healing by topicaladministration of tranexamic acid.; MedDRA version: 20.0Level: LLTClassification code 10002784Term: AntifibrinolysisSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2021-001381-38-DK
• Lead Sponsor: Plastikkirurgisk og brystkirurgisk afdeling, Region Sjælland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-22
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

All criteria must be met
- Surgery where split thickness skin grafts are harvested
- able patients
- signed informed consent
- Danish in writing and speech
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- unable patients
- Surgery where there wil not be harvested of split thickness skin grafts
- Lacking signed informed consent
- Immunological conditions, including autoimmune conditions such as
rheumatoid arthritis, diabetes mellitus, inflammatory bowel disease,
Lupus Erythematosus, Multiple Sclerosis, psoriasis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified