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Patch With Onion Extract and Allantoin for C-section Scar

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04046783
Recruitment Status : Completed
First Posted : August 6, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Prof Valeria Conti, University of Salerno

Study Description
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Brief Summary:

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
Cesarean Section; Dehiscence Scar Keloid Wound Heal Device: patch

Detailed Description:
This is an observational non-interventional study. Women who underwent C-section were consecutively recruited at University Hospital of Salerno. Taking into account the number of C-section the study population was divided into two groups: Group A included subjects without a prior history of C-section, group B subjects who had already undergone previous C-section. At baseline after stitches removal, scars assessment was made using digital photographs and the validate Patient and Observer Scar Assessment Scale (POSAS). After 4 weeks, during the outpatient visit, women from both group A and B were asked whether had applied some natural products on the scars or not. In this occasion, the C-section of the women who had applied a patch containing allium cepa and allantoin as well as those of women who had not used any products (who represented the control group) were re-evaluated as at baseline. The Observers were blinded. One of them performed the scars assessment at baseline, the other one after 4 weeks. During the outpatient visit an informed consent for participation was obtained by all the subjects costituing the study population. The participation to the study was voluntary
Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Allantoin

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
 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
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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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
Study Population
The study population was represented by adult women, subdivided in two groups, A and B on the basis of the number of Cesearean delivery. Group A included subjects without a prior history of Cesarean delivery, Group B subjects who had already undergone previous Cesarean delivery. All the women were enrolled at University Hospital of Salerno, were >=18 years old without hypersensitivity to any constituent of the patch, who have not experienced pre-term birth, obesity, gestational diabetes, hypertension, infections, dermatologic diseases and use of both systemic and topic corticosteroids. All the partecipants were volunteers and released a written informed consent
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Italy
University of Salerno, Dept. of Medicine
Baronissi, Campania, Italy, 84081
Sponsors and Collaborators
University of Salerno
Investigators
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Principal Investigator: Valeria Conti, PhD Department of Medicine,University of Salerno, Baronissi (SA), Italy
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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

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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
Keywords provided by Prof Valeria Conti, University of Salerno:
Natural products
Wound healing
Cesarean delivery
Additional relevant MeSH terms:
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Keloid
Collagen Diseases
Connective Tissue Diseases
 Cicatrix
Fibrosis
Pathologic Processes