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 range18 Years
SexALL
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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 …
What they're measuring
1
Reducing the bleeding time in the donor site of skin grafting