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

NCT ID: NCT02012569

Last Updated: 2016-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-07-31

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

Conditions

Burns; Traumatic Lesions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TT.173

It is applied directly to the bleeding of the donor site

Group Type: EXPERIMENTAL

TT-173

Intervention Type: DRUG

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

It is applied directly to the bleeding of the donor site

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

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.

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

topical hemostatic agent

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.

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

• -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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thrombotargets Europe S.L

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Santiago Rojas, Manager

Role: STUDY_DIRECTOR

Thrombotargets Europe

Locations

Thrombotargets Europe

Castelldefels, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 26374745 (View on PubMed)

Related Links

http://link.springer.com/article/10.1007%2Fs00784-015-1586-1

For more information about this study: Clinical Oral Investigations journal

Other Identifiers

2013-002784-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

THO-IM_01-CT

Identifier Type: -

Identifier Source: org_study_id