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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 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;

  1. Observation of the primary cesarean scar by taking scar measurements and using Vancouver and POSAS scales.
  2. Surgical removal of the primary cesarean scar in the second cesarean section.
  3. 24 weeks topical application of gel containing extract of allium cepae, allantoin and heparin(only treatment group).
  4. Observation of the skin incision at 6,12 and 24 weeks by taking scar measurements with using Vancouver and POSAS scales.

Sponsor: Suleymaniye Birth And Women's Health Education And Research Hospital

Current Primary Outcome:

  • 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: just prior to second c-section and at 6,12,24 weeks ]


Original Primary Outcome:

  • 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 24 weeks ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Suleymaniye Birth And Women's Health Education And Research Hospital

Dates:
Date Received: February 29, 2016
Date Started: December 2015
Date Completion:
Last Updated: October 2, 2016
Last Verified: March 2016