Determine the Haemostatic Efficacy of TT-173, Reducing the Bleeding Time in the Donor Site of Ski… (NCT02012569) | Clinical Trial Compass
CompletedPhase 2
Determine the Haemostatic Efficacy of TT-173, Reducing the Bleeding Time in the Donor Site of Skin Grafting
Spain78 participantsStarted 2013-11
Plain-language summary
The purpose of this study is to determine the haemostatic efficacy of TT-173, reducing the bleeding time in the donor site of skin grafting.
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:
* Subjects who signed the informed consent.
* Subjects that have to undergo a skin graft.
* Subjects of both sexes older than 18 years.
* Subjects that present a burn or traumatic skin injury affecting less than 30% of corporal surface.
* Subjects with a platelet count not compatible with pathology.
* Subjects who present haemogram results not indicative of any of the situations mentioned in the exclusion criteria.
* Subjects who present biochemical results not indicative of any of the situations mentioned in the exclusion criteria.
* Subjects who present coagulation parameters not indicative of any of the situations mentioned in the exclusion criteria.
* Women of childbearing age who take contraceptive measures and are willing to maintain them until the end of follow up of this study.
* Women of childbearing age who present a negative test pregnancy at the moment of study inclusion
Exclusion Criteria:
* -Subjects with personal or family history of abnormal hemorrhagic episodes.
* Subjects affected of any kind of congenital or acquired coagulopathies.
* Subjects that present a burn or traumatic skin injury affecting more than 31% of corporal surface.
* Subjects affected of any blood, heart or liver disease, chronic renal failure, severe chronic obstructive pulmonary disease, active oncologic process in the past three months, diabetes type I or who has suffered a stroke.
* Subjects who experienced excessive bleeding after surgical procedures, childbirth …
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.
What they're measuring
1
Reducing the bleeding time in the donor site of skin grafting