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The purpose of this study is to investigate the efficacy of Contractubex® Gel, containing extractum cepae, allantoin and heparin, in the treatment of scars after abdominal Caesarean section compared to untreated scars after abdominal Caesarean section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contractubex | Experimental |
| |
| Non treatment | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contractubex | Drug | Contractubex® Gel, containing 10% extractum cepae, 1% allantoin and 50/U of sodium heparin per one gram of gel. Active drug group: The gel will be applied twice daily (morning/evening). Approximately 2 cm of the IMP are applied onto the scar by light massage rubbing carefully until the product is worked in. |
| Measure | Description | Time Frame |
|---|---|---|
| Appearance of the scars will be evaluated by use of the Patient and Observer Scar Assessment Scale [POSAS]. | The scale consists of two numeric scales which need to be filled out by the observer and the patient, respectively. | Screening and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Appearance of the scars will be evaluated by use of the Patient and Observer Scar Assessment Scale [POSAS]. | The scale consists of two numeric scales which need to be filled out by the observer and the patient, respectively. | Screening and 6 weeks |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Ocampo Candiani, MD | Jefe del Departamento Dermatologia, Facultad de medicina y Hospital Universitario, Universidad Autonoma de Nuevo León, Monterrey Nuevo León,C.P. 64460, Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefe del Departamento Dermatologia, Facultad de medicina y Hospital Universitario, Universidad Autonoma de Nuevo León | Monterrey Nuevo León | C.p. | 64460 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Ocampo-Candiani J, et al. Efficacy of a topical gel containing extractum cepae, allantoin and heparin in the treatment of abdominal caesarean section scars. IMCAS Annual Meeting 2013. www.imcas.com/en/imcas2013/schedule/lecture/id/5971 | ||
| 24509969 | Result | Ocampo-Candiani J, Vazquez-Martinez OT, Iglesias Benavides JL, Buske K, Lehn A, Acker C. The prophylactic use of a topical scar gel containing extract of Allium cepae, allantoin, and heparin improves symptoms and appearance of cesarean-section scars compared with untreated scars. J Drugs Dermatol. 2014 Feb;13(2):176-82. |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C053099 | allantoin, heparin, onion extract drug combination |
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