CicatrixNCT02708628
The Efficacy of Extract of Allium Cepae, Allantoin and Heparin in Patients With Proven Scar Development
A study testing extract of allium cepae, allantoin and heparin and Scar excision in people with Cicatrix, run by Suleymaniye Birth And Women's Health Education And Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cicatrix
- What is being tested?
- extract of allium cepae, allantoin and heparin and Scar excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who are admitted for the second cesarean delivery
- Not to use topical scar gel after the first c-section
Who cannot join
- chronic illness, immunosuppressive therapy or smoking
- development of wound infection during the second c- section
- allergies and hypersensitivities to components of the gel
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Suleymaniye Birth And Women's Health Education And Research Hospital.
Istanbul, 34020
About this study
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
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.
Read the 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.
- Conditions
- Cicatrix
- Being tested
- extract of allium cepae, allantoin and heparin, Scar excision
- Keywords
- scar prevention, sectio, extract of allium cepae, allantoin, heparin
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extract of allium cepae, allantoin and heparinDrug
Also called Contractubex
prophylactic use of a topical gel containing extract of allium cepae, allantoin and heparin two times in a day after second c-section
Scar excisionProcedure or surgery
Scar excision in second c-section
| Study group | Role | What they receive |
|---|---|---|
| Patients using contractubex | Active comparator | 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. Receives: Drug: extract of allium cepae, allantoin and heparin; Procedure: Scar excision |
| Patients not using contractubex | Active comparator | 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. Receives: Procedure: Scar excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: just prior to second c-section and at 6,12,24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startDec 2015
- Primary completionApr 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CicatrixStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleymaniye Birth And Women's Health Education And Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ali Galip Zebitay, M.D., Principal investigator, Suleymaniye Birth And Women's Health Education And Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708628
- Sponsor's protocol ID
- AGZ-EAC-A-H-1
- Status last verified
- Mar 2016
- First submitted
- 29 Feb 2016
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02708628
- Acronym / sponsor ID
- AGZ-EAC-A-H-1
- Conditions
- Cicatrix
- Keywords
- scar prevention, sectio, extract of allium cepae, allantoin, heparin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Suleymaniye Birth And Women's Health Education And Research HospitalOther government
- Study start
- Dec 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients using contractubex | Active comparator | Drug: extract of allium cepae, allantoin and heparin, Procedure: Scar excisionScar 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. |
| Patients not using contractubex | Active comparator | Procedure: Scar excisionScar 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients who are admitted for the second cesarean delivery
- Not to use topical scar gel after the first c-section
Key exclusion criteria (3 listed)
- chronic illness, immunosuppressive therapy or smoking
- development of wound infection during the second c- section
- allergies and hypersensitivities to components of the gel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extract of allium cepae, allantoin and heparinAlso: Contractubexprophylactic use of a topical gel containing extract of allium cepae, allantoin and heparin two times in a day after second c-section | Drug | Patients using contractubex |
| Scar excisionScar excision in second c-section | Procedure or surgery | Patients not using contractubex, Patients using contractubex |
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Cicatrix
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SCARFREE-001: Verteporfin for Scar Prevention
Surgical Scar
Enrolling by invitation
Nanofat Injection and Fractional CO2 Laser for Post-Traumatic Atrophic Scars
Post-Traumatic Atrophic Scar, Atrophic Scar
Not yet recruitingPhase 2
Phase II Clinical Study on Preliminary Efficacy and Safety of ETD-001 Gel for Hypertrophic Scars
Hypertrophic Scars
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Galip Zebitay, M.D. principal investigator
Suleymaniye Birth And Women's Health Education And Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extract of allium cepae, allantoin and heparin and Scar excision in people with Cicatrix, run by Suleymaniye Birth And Women's Health Education And Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: just prior to second c-section and at 6,12,24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016; AzTrials last refreshed its copy on 8 Nov 2026.