Clinical trial NCT02012569: Determine the Haemostatic Efficacy of TT-173, Reducing the Bleeding Time in the Donor Site of Skin Grafting
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Burns
Traumatic Lesions
Keywords: skin grafting
elective treatment
Lead sponsor: Thrombotargets Europe S.L
Sponsor class: INDUSTRY
First posted: 2013-12-16
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Primary outcomes:
measure: Reducing the bleeding time in the donor site of skin grafting
timeFrame: 10 min
Secondary outcomes:
measure: Safety and tolertability
timeFrame: 1 month
measure: Systemic absorption of the product
timeFrame: 1 month
measure: Immunogenicity
timeFrame: 1 month
Other outcomes:
Locations:
city: Castelldefels
country: Spain
facility: Thrombotargets Europe
state: Barcelona
Study officials:
affiliation: Thrombotargets Europe
name: Santiago Rojas, Manager
role: STUDY_DIRECTOR
References:
citation: Lopez-Lopez J, Jane-Salas E, Santamaria A, Gonzalez-Navarro B, Arranz-Obispo C, Lopez R, Miquel I, Arias B, Sanchez P, Rincon E, Rodriguez JR, Rojas S, Murat J. TETIS study: evaluation of new topical hemostatic agent TT-173 in tooth extraction. Clin Oral Investig. 2016 Jun;20(5):1055-63. doi: 10.1007/s00784-015-1586-1. Epub 2015 Sep 15.