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

Burns Clinical Trial

— EHTIC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012569
• Other study ID #: THO-IM_01-CT
• Secondary ID: 2013-002784-25
• Status: Completed
• Phase: Phase 2
• First received: November 21, 2013
• Last updated: February 23, 2016
• Start date: November 2013
• Est. completion date: July 2015

Study information

• Verified date: November 2015
• Source: Thrombotargets Europe S.L
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Traumatic Lesions

Intervention

Drug:
• TT-173
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.
• Placebo

Locations

Country	Name	City	State
Spain	Thrombotargets Europe	Castelldefels	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Thrombotargets Europe S.L

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reducing the bleeding time in the donor site of skin grafting		10 min	No
Secondary	Safety and tolertability	Number of Adverse Events	1 month	Yes
Secondary	Systemic absorption of the product	Cmax, Tmax, AUC and bioavailability	1 month	No
Secondary	Immunogenicity	Antibody concentration	1 month	Yes