Patch With Onion Extract and Allantoin for C-section Scar

Completed

• Conditions: Cesarean Section; Dehiscence; Scar Keloid; Wound Heal
• Interventions: Device: patch

• Registration Number: NCT04046783
• Lead Sponsor: University of Salerno

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.

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 Timeline

• Study Start: 2019-03-02
• Primary Completion: 2019-07-30
• Study Completion: 2019-07-31
• Study First Submitted: 2019-07-31
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-06
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 93

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A included subjects without a history of C-section	patch	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
group B subjects who had already undergone previous C-section	patch	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

Primary Outcome Measures

Name	Time	Method
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.	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

Trial Locations

Locations (1)

University of Salerno, Dept. of Medicine; 🇮🇹 Baronissi, Campania, Italy