Patch With Onion Extract and Allantoin for C-section Scar

Wound Heal Clinical Trial

Official title:

Effectiveness and Tolerability of an Overnight 4-week Treatment With Patch Containing Onion Extract and Allantoin for Cesarean Section Scars

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04046783
• Other study ID #: USalerno
• Status: Completed
• Start date: March 2, 2019
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2019
• Source: University of Salerno
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: July 31, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section; Dehiscence
• Keloid
• Scar Keloid
• Wound Heal

Intervention

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.

Locations

Country	Name	City	State
Italy	University of Salerno, Dept. of Medicine	Baronissi	Campania

Sponsors (1)

Lead Sponsor	Collaborator
University of Salerno

Country where clinical trial is conducted

Italy, 

References & Publications (11)

Araújo LU, Grabe-Guimarães A, Mosqueira VC, Carneiro CM, Silva-Barcellos NM. Profile of wound healing process induced by allantoin. Acta Cir Bras. 2010 Oct;25(5):460-6. — View Citation

Chuangsuwanich A, Jongjamfa K. The efficacy of combined herbal extracts gel preparation in the prevention of postsurgical hypertrophic scar formation. Dermatol Ther (Heidelb). 2014 Dec;4(2):187-95. doi: 10.1007/s13555-014-0055-0. Epub 2014 Jun 25. — View Citation

Fang QQ, Chen CY, Zhang MX, Huang CL, Wang XW, Xu JH, Wu LH, Zhang LY, Tan WQ. The Effectiveness of Topical Anti-scarring Agents and a Novel Combined Process on Cutaneous Scar Management. Curr Pharm Des. 2017;23(15):2268-2275. doi: 10.2174/138161282266616 — View Citation

Fearmonti RM, Bond JE, Erdmann D, Levin LS, Pizzo SV, Levinson H. The modified Patient and Observer Scar Assessment Scale: a novel approach to defining pathologic and nonpathologic scarring. Plast Reconstr Surg. 2011 Jan;127(1):242-7. doi: 10.1097/PRS.0b0 — View Citation

Gauglitz GG, Korting HC, Pavicic T, Ruzicka T, Jeschke MG. Hypertrophic scarring and keloids: pathomechanisms and current and emerging treatment strategies. Mol Med. 2011 Jan-Feb;17(1-2):113-25. doi: 10.2119/molmed.2009.00153. Epub 2010 Oct 5. Review. — View Citation

Ho WS, Ying SY, Chan PC, Chan HH. Use of onion extract, heparin, allantoin gel in prevention of scarring in chinese patients having laser removal of tattoos: a prospective randomized controlled trial. Dermatol Surg. 2006 Jul;32(7):891-6. — View Citation

Pikula M, Zebrowska ME, Poblocka-Olech L, Krauze-Baranowska M, Sznitowska M, Trzonkowski P. Effect of enoxaparin and onion extract on human skin fibroblast cell line - therapeutic implications for the treatment of keloids. Pharm Biol. 2014 Feb;52(2):262-7 — View Citation

Prager W, Gauglitz GG. Effectiveness and Safety of an Overnight Patch Containing Allium cepa Extract and Allantoin for Post-Dermatologic Surgery Scars. Aesthetic Plast Surg. 2018 Aug;42(4):1144-1150. doi: 10.1007/s00266-018-1172-4. Epub 2018 Jun 14. — View Citation

Rose P, Whiteman M, Moore PK, Zhu YZ. Bioactive S-alk(en)yl cysteine sulfoxide metabolites in the genus Allium: the chemistry of potential therapeutic agents. Nat Prod Rep. 2005 Jun;22(3):351-68. Epub 2005 May 10. Review. — View Citation

Sidgwick GP, McGeorge D, Bayat A. A comprehensive evidence-based review on the role of topicals and dressings in the management of skin scarring. Arch Dermatol Res. 2015 Aug;307(6):461-77. doi: 10.1007/s00403-015-1572-0. Epub 2015 Jun 5. Review. — View Citation

Willital GH, Heine H. Efficacy of Contractubex gel in the treatment of fresh scars after thoracic surgery in children and adolescents. Int J Clin Pharmacol Res. 1994;14(5-6):193-202. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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).