Clinical trial NCT02708628: The Efficacy of Extract of Allium Cepae, Allantoin and Heparin in Patients With Proven Scar Development
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cicatrix
Keywords: scar prevention
sectio
extract of allium cepae
allantoin
heparin
Lead sponsor: Suleymaniye Birth And Women's Health Education And Research Hospital
Sponsor class: OTHER_GOV
First posted: 2016-03-15
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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;

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.

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

Primary outcomes:
measure: 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.
timeFrame: just prior to second c-section and at 6,12,24 weeks
measure: 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.
timeFrame: just prior to second c-section and at 6,12,24 weeks
measure: 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.
timeFrame: just prior to second c-section and at 6,12,24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Suleymaniye Birth And Women's Health Education And Research Hospital.
Study officials:
affiliation: Suleymaniye Birth And Women's Health Education And Research Hospital
name: Ali Galip Zebitay, M.D.
role: PRINCIPAL_INVESTIGATOR
References: