Clinical trial NCT04046783: Patch With Onion Extract and Allantoin for C-section Scar
Official title: Effectiveness and Tolerability of an Overnight 4-week Treatment With Patch Containing Onion Extract and Allantoin for Cesarean Section Scars
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section; Dehiscence
Scar Keloid
Wound Heal
Keywords: Natural products
Wound healing
Cesarean delivery
Lead sponsor: University of Salerno
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Baronissi
country: Italy
facility: University of Salerno, Dept. of Medicine
state: Campania
Study officials:
affiliation: Department of Medicine,University of Salerno, Baronissi (SA), Italy
name: Valeria Conti, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Conti V, Corbi G, Iannaccone T, Corrado B, Giugliano L, Lembo S, Filippelli A, Guida M. Effectiveness and Tolerability of a Patch Containing Onion Extract and Allantoin for Cesarean Section Scars. Front Pharmacol. 2020 Sep 25;11:569514. doi: 10.3389/fphar.2020.569514. eCollection 2020.