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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Burns, Traumatic Lesions

Intervention / Treatment
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* Drug: TT-173
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TT.173<br>It is applied directly to the bleeding of the donor site | Drug: TT-173<br>* Bleeding of the lesion will be evaluated after each product application and will be recorded as bleeding vs. not bleeding. The product will be applied at 4 times for about 1 minute apart each application after skin graft obtention.<br>* Other names: topical hemostatic agent;|
| Placebo Comparator: placebo<br>It is applied directly to the bleeding of the donor site | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing the bleeding time in the donor site of skin grafting |  | 10 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolertability | Number of Adverse Events | 1 month | 
| Systemic absorption of the product | Cmax, Tmax, AUC and bioavailability | 1 month | 
| Immunogenicity | Antibody concentration | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin grafting, elective treatment