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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02012569

Acronym

EHTIC

Enrollment

Registered

2013-12-16

Start date

2013-11-30

Completion date

2015-07-31

Last updated

2016-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns, Traumatic Lesions

Keywords

skin grafting, elective 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

Interventions

DRUGTT-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.

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Reducing the bleeding time in the donor site of skin grafting	10 min

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026