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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002784-25 | EudraCT Number |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TT.173 | Experimental | It is applied directly to the bleeding of the donor site |
|
| placebo | Placebo Comparator | It is applied directly to the bleeding of the donor site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TT-173 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reducing the bleeding time in the donor site of skin grafting | 10 min |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolertability | Number of Adverse Events | 1 month |
| Systemic absorption of the product | Cmax, Tmax, AUC and bioavailability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Santiago Rojas, Manager | Thrombotargets Europe | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thrombotargets Europe | Castelldefels | Barcelona | 08860 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26374745 | Background | 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. |
| Label | URL |
|---|---|
| For more information about this study: Clinical Oral Investigations journal | View source |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D006487 | Hemostasis |
| ID | Term |
|---|---|
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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|
| Placebo | Drug |
|
| 1 month |
| Immunogenicity | Antibody concentration | 1 month |