The Efficacy of Extract of Allium Cepae, Allantoin and Heparin in Patients With Proven Scar Development

Study Overview
=================
Brief Summary
-----------------
To investigate the efficacy of prophylactic use of a topical gel containing extract of allium cepae, allantoin and heparin after surgical removal of the primary cesarean scar in the second cesarean section.

Detailed Description
-----------------
120 patients who are admitted for the second cesarean delivery, not taking prophylactic medication after the first cesarean section, whose scar development and measurements are taken will be included in the study. First caesarean section scars will be removed surgically for all patients. 60 out of 120 patients (treatment group) will use prophylactic topical scar gel 2 times in a day, and remaining 60 patients (control group )won't use. The efficacy of the drug will be evaluated by taking strict measurements of the incision and POSAS (The Patient and Observer Scar Assessment Scale) and Vancouver Scales at 6.12 and 24 weeks. Steps; Observation of the primary cesarean scar by taking scar measurements and using Vancouver and POSAS scales. Surgical removal of the primary cesarean scar in the second cesarean section. 24 weeks topical application of gel containing extract of allium cepae, allantoin and heparin(only treatment group). Observation of the skin incision at 6,12 and 24 weeks by taking scar measurements with using Vancouver and POSAS scales.

Official Title
-----------------
The Efficacy of Prophylactic Use of Extract of Allium Cepae, Allantoin and Heparin in Patients With Proven Scar Development After Excision of Previous Scar

Conditions
-----------------
Cicatrix

Intervention / Treatment
-----------------
* Drug: extract of allium cepae, allantoin and heparin
* Procedure: Scar excision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are admitted for the second cesarean delivery Not to use topical scar gel after the first c-section Exclusion Criteria: chronic illness, immunosuppressive therapy or smoking development of wound infection during the second c- section allergies and hypersensitivities to components of the gel

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients using contractubex<br>Scar excision will be performed in second c-section for 60 patients and these patients will use prophylactic topical scar gel containing extract of allium cepae, allantoin and heparin two times in a day. | Drug: extract of allium cepae, allantoin and heparin<br>* prophylactic use of a topical gel containing extract of allium cepae, allantoin and heparin two times in a day after second c-section<br>* Other names: Contractubex;Procedure: Scar excision<br>* Scar excision in second c-section<br>|
| Active Comparator: Patients not using contractubex<br>Scar excision will be performed in second c-section for 60 patients and these patients will not use prophylactic topical scar gel containing extract of allium cepae, allantoin and heparin. | Procedure: Scar excision<br>* Scar excision in second c-section<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POSAS observer score change will be assessed by POSAS observer scale (The Patient and Observer Scar Assessment Scale v2.0) just prior to second c-section and at 6,12 and 24 weeks following the c-section. |  | just prior to second c-section and at 6,12,24 weeks | 
| POSAS patient score change will be assessed by POSAS patient scale (The Patient and Observer Scar Assessment Scale v2.0) just prior to second c-section and at 6,12 and 24 weeks following the c-section. |  | just prior to second c-section and at 6,12,24 weeks | 
| Vancouver scar score change will be assessed by Vancouver scar scale just prior to second c-section and at 6,12 and 24 weeks following the c-section. |  | just prior to second c-section and at 6,12,24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
scar prevention, sectio, extract of allium cepae, allantoin, heparin