Moistening the innermost wound dressings with the drug tranexamic acid to prevent bleeding and wound effusion in patients with superficial wounds

Phase 1

• Conditions: Postoperative bleeding and wound effusion from wounds created by tangential skin excision; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2015-004342-26-NO
• Lead Sponsor: Department of Surgery, St Olav's University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-21
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Patients above 18 years of age to undergo split skin graft harvesting and hence getting a tangential superficial wound at the donor site, or patients who are to undergo tangential excisional revision of superficial wounds.
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Patients who may be pregnant or who are nursing are not eligible for the study. Patients will receive a very low dose with tranexamic acid, of which a fraction can be expected to be absorbed systemically. As large studies have not found any increased risk of thromboembolic events or other adverse events from administering larger doses of tranexamic acid intravenously, we do not have any exclusion criteria for participation in the study due to fear of adverse effects.
Patients who are known to be allergic to tranexamic acid will be excluded from the study.

Study & Design

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