Determine the Haemostatic Efficacy of TT-173, Reducing the Bleeding Time in the Donor Site of Skin Grafting

A Phase II Randomized, Controlled, Single Blind Study to Evaluate the Haemostatic Efficacy and Safety of TT-173 Applied in the Donor Site of Patients Undergoing Skin Graft

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.

As the TT-113 has been cleared for use as a topical hemostatic agent, the proposed study will further investigate the safety and efficacy of TT-113 in the donor site of sking grafting

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 or tooth extraction.
• Subjects affected by any acute infectious disease.
• Subjects affected of any systemic disease that may worsen the prognosis if any adverse effect occurs (decompensated type 2 diabetes mellitus, uncontrolled hypertension or severe systemic disease).
• Subjects who should take antiplatelet therapies one week before and 48 hours after the surgery (AAS, trifusal, dipiridamol, clopidogrel, abciximab).
• Subjects with known hypersensitivity or allergy to any component of the drug.
• Subjects who consume abuse drugs excluding cannabis and its derivatives.
• Subjects who are unable to follow or understand properly the instructions and requirements of the study.
• Subjects who are not free to give informed consent or who are mentally incapacitated to the discretion of investigators.
• Subjects who participate or have participated in the past three months in another clinical trial with drug treatment.
• Subjects that are the investigators, collaborators, nurses, center employees or any other person directly related to the development of the protocol.
• Subjects who are positive to HIV or HCV serology, or who present active HBV infection.
• Subjects who are pregnant or lactating.