The Effect of Topical Tranexamic Acid on Postoperative Bleeding From Superficial Wounds (NCT02918201) | Clinical Trial Compass
CompletedPhase 2
The Effect of Topical Tranexamic Acid on Postoperative Bleeding From Superficial Wounds
Norway36 participantsStarted 2020-01-01
Plain-language summary
After surgical procedures, interventions to reduce postoperative bleeding are of great importance. In this study, the effect will be investigated of administering tranexamic acid, which is designed for injection, directly onto the raw wound surface (topical application) created during surgery. In this way only a small amount of drug is to reach a large wound area. There will be a higher drug concentration of it in the exposed wound surface than after injection, but only a very low concentration in the body, and no risk of injury from needles. The researchers have recently shown that topically applicated tranexamic acid reduces bleeding in women who had two-sided breast reduction surgery. Now it will be studied whether topically applicated tranexamic acid reduces bleeding from superficial wounds, using as a study model the homogenous wounds created by tangential skin excision when harvesting split skin grafts for skin transplants. Two identical wound surfaces in the same patient will serve as case and control.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* to undergo split skin graft harvesting
* two equally large and symmetrically distributed wounds can be defined in the donor area
* received adequate oral and written information about the study and signed an informed-consent form. For those not capable of giving informed consent at the time of inclusion but included via next-of-kin, consent will be obtained or withdrawn when the patient is able to independently consider the inclusion
Exclusion Criteria:
* pregnant or breastfeeding
* known allergy to tranexamic acid/Cyklokapron®
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.