NCT02012569

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2013

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

April 22, 2016

Status Verified

November 1, 2015

Enrollment Period

1.7 years

First QC Date

November 21, 2013

Last Update Submit

April 21, 2016

Conditions

BurnsTraumatic Lesions

Keywords

skin graftingelective treatment

Outcome Measures

Primary Outcomes (1)

  • Reducing the bleeding time in the donor site of skin grafting

    10 min

Secondary Outcomes (3)

  • Safety and tolertability

    1 month

  • Systemic absorption of the product

    1 month

  • Immunogenicity

    1 month

Study Arms (2)

TT.173

EXPERIMENTAL

It is applied directly to the bleeding of the donor site

Drug: TT-173

placebo

PLACEBO COMPARATOR

It is applied directly to the bleeding of the donor site

Drug: Placebo

Interventions

TT-173DRUG

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.

Also known as: topical hemostatic agent
TT.173
PlaceboDRUG
placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Women of childbearing age who take contraceptive measures and are willing to maintain them until the end of follow up of this study.
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thrombotargets Europe

Castelldefels, Barcelona, 08860, Spain

Location

Related Publications (1)

  • 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.

    PMID: 26374745BACKGROUND

Related Links

MeSH Terms

Conditions

Burns

Interventions

Hemostasis

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Blood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Santiago Rojas, Manager

    Thrombotargets Europe

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2013

First Posted

December 16, 2013

Study Start

November 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

April 22, 2016

Record last verified: 2015-11

Locations

ES(1)