Patch With Onion Extract and Allantoin for C-section Scar
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ClinicalTrials.gov Identifier: NCT04046783 |
Recruitment Status :
Completed
First Posted : August 6, 2019
Last Update Posted : August 26, 2019
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The wound healing is a process occurring in response to dermal injury. The resulting scar may have various characteristics ranging from fine-line and asymptomatic to hypertrophic scars and keloids. Prevention or early treatment of pathological scars is the most appropriate approach. Among available remedies, gels and patches containing onion extract and allantoin have been demonstrated to be safe and effective in patients with scars of various origins and severity.
One of the most used natural products is a patch containing allium cepa and allantoin licensed for treatment of the scars including keloids. However, up to date, no controlled studies have evaluated the effects of such a device in women who have undergone Cesarean delivery. Therefore, the aim of this study was to investigate the effects of this patch on Cesarean section (C-section) scars.
Condition or disease | Intervention/treatment |
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Cesarean Section; Dehiscence Scar Keloid Wound Heal | Device: patch |
Study Type : | Observational |
Actual Enrollment : | 93 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Effectiveness and Tolerability of an Overnight 4-week Treatment With Patch Containing Onion Extract and Allantoin for Cesarean Section Scars |
Actual Study Start Date : | March 2, 2019 |
Actual Primary Completion Date : | July 30, 2019 |
Actual Study Completion Date : | July 31, 2019 |

Group/Cohort | Intervention/treatment |
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Group A included subjects without a history of C-section
Group A consisted of 47 women without a prior a history of C-section: 24 controls and 23 subjects who used patch. These latest 23 subjects applied overnight a patch containing a standardized quantity of Allium Cepa extract and allantoin on C-section scars over 4 weeks
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Device: patch
an overnight application of a patch containing a standardized quantity of Allium Cepa extract and allantoin on C-section scars over 4 weeks. |
group B subjects who had already undergone previous C-section
Group B consisted of 46 women already undergone previous C-section: 22 controls and 24 subjects who used patch. These latest 24 subjects applied overnight a patch containing a standardized quantity of Allium Cepa extract and allantoin on C-section scars over 4 weeks
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Device: patch
an overnight application of a patch containing a standardized quantity of Allium Cepa extract and allantoin on C-section scars over 4 weeks. |
- Effectiveness of an overnight 4-week Treatment with Patch containing Onion Extract and Allantoin for Cesarean Section Scars in women undergone to Cesarean section as assed by POSAS v.2.0. [ Time Frame: Scars were evaluated at baseline and after 4 weeks by two observers and by the subjects.Scars assessment was made using digital photographs and the validate Patient and Observer Scar Assessment Scale (POSAS, version 2.0). ]The primary outcome was represented by the number of women undergone a Cesarean section (C-section) that used for 4-week a patch containing Allium Cepa extract and allantoin in respect to controls. The Patient and Observer Scar Assessment Scale (POSAS) was used to compare the differences from baseline to 4-week treatment and between controls and subjects using the patch

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | women who have undergone Cesarean delivery |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- subjects undergone Cesarean delivery;
- age >18;
- voluntary participation to the study;
- informed consent release.
Exclusion Criteria:
- age <18
- hypersensitivity to any constituent of the patch;
- pre-term birth, obesity,
- gestational diabetes,
- hypertension,
- infections,
- dermatologic diseases
- use of both systemic and topic corticosteroids;
- no informed consent release.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046783
Italy | |
University of Salerno, Dept. of Medicine | |
Baronissi, Campania, Italy, 84081 |
Principal Investigator: | Valeria Conti, PhD | Department of Medicine,University of Salerno, Baronissi (SA), Italy |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Prof Valeria Conti, Professor, University of Salerno |
ClinicalTrials.gov Identifier: | NCT04046783 |
Other Study ID Numbers: |
USalerno |
First Posted: | August 6, 2019 Key Record Dates |
Last Update Posted: | August 26, 2019 |
Last Verified: | August 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Natural products Wound healing Cesarean delivery |
Keloid Collagen Diseases Connective Tissue Diseases |
Cicatrix Fibrosis Pathologic Processes |