BurnsPhase 2EHTICNCT02012569
Determine the Haemostatic Efficacy of TT-173, Reducing the Bleeding Time in the Donor Site of Skin Grafting
A Phase 2 study testing TT-173 in people with Burns and Traumatic Lesions, run by Thrombotargets Europe S.L at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Traumatic Lesions
- What is being tested?
- TT-173
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2013to Jul 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- -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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- TT-173, Placebo
- Keywords
- skin grafting, elective treatment
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TT-173Drug
Also called topical hemostatic agent
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.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| TT.173 | Experimental | It is applied directly to the bleeding of the donor site Receives: Drug: TT-173 |
| placebo | Placebo comparator | It is applied directly to the bleeding of the donor site Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing the bleeding time in the donor site of skin grafting
Measured: 10 min
Secondary outcomes (3)
Safety and tolertability
Number of Adverse Events
Measured: 1 month
Systemic absorption of the product
Cmax, Tmax, AUC and bioavailability
Measured: 1 month
Immunogenicity
Antibody concentration
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thrombotargets Europe S.L
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Santiago Rojas, Manager, Study director, Thrombotargets Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012569
- Sponsor's protocol ID
- THO-IM_01-CT
- Other IDs
- 2013-002784-25
- Acronym
- EHTIC
- Status last verified
- Nov 2015
- First submitted
- 21 Nov 2013
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 26374745
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02012569
- Acronym / sponsor ID
- EHTIC / THO-IM_01-CT
- Conditions
- Burns, Traumatic Lesions
- Keywords
- skin grafting, elective treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Thrombotargets Europe S.LIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TT.173 | Experimental | Drug: TT-173It is applied directly to the bleeding of the donor site |
| placebo | Placebo comparator | Drug: PlaceboIt is applied directly to the bleeding of the donor site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (16 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TT-173Also: topical hemostatic agentBleeding 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. | Drug | TT.173 |
| Placebo | Drug | placebo |
Primary outcome
Reducing the bleeding time in the donor site of skin grafting
Time frame: 10 min
3 secondary outcomes
Safety and tolertability
Time frame: 1 month
Systemic absorption of the product
Time frame: 1 month
Immunogenicity
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
- Background: PubMed 26374745Lopez-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.
- For more information about this study: Clinical Oral Investigations journalLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santiago Rojas, Manager study director
Thrombotargets Europe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TT-173 in people with Burns and Traumatic Lesions, run by Thrombotargets Europe S.L at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reducing the bleeding time in the donor site of skin grafting (time frame: 10 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02012569, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2016.