determine the haemostatic efficacy of tt-173, reducing the bleeding time in the donor site of skin grafting

Conditions: Burns; Traumatic Lesions

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.

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

Eligibility criteria:
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.

Keywords: skin grafting elective treatment