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

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.

Study Overview

• Status: Completed
• Conditions: Burns; Traumatic Lesions
• Intervention / Treatment: Drug: Placebo; Drug: TT-173

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

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Castelldefels, Barcelona, Spain, 08860
      • Thrombotargets Europe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TT.173; It is applied directly to the bleeding of the donor site	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.; Other Names: topical hemostatic agent
Placebo Comparator: placebo; It is applied directly to the bleeding of the donor site	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Thrombotargets Europe S.L
• Investigators: Study Director: Santiago Rojas, Manager, Thrombotargets Europe

Publications and helpful links

General Publications

• 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.

Helpful Links

• For more information about this study: Clinical Oral Investigations journal

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: November 21, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 16, 2013

Study Record Updates

• Last Update Posted (Estimate): April 22, 2016
• Last Update Submitted That Met QC Criteria: April 21, 2016
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: skin grafting; elective treatment
• Additional Relevant MeSH Terms: Coagulants; Hemostatics
• Other Study ID Numbers: THO-IM_01-CT; 2013-002784-25 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED