NCT04046783

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
Last Updated

August 26, 2019

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

July 31, 2019

Last Update Submit

August 21, 2019

Conditions

Cesarean Section; DehiscenceScar KeloidWound Heal

Keywords

Natural productsWound healingCesarean delivery

Outcome Measures

Primary Outcomes (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.

    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).

Study Arms (2)

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

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

Interventions

patchDEVICE

an overnight application of a patch containing a standardized quantity of Allium Cepa extract and allantoin on C-section scars over 4 weeks.

Group A included subjects without a history of C-sectiongroup B subjects who had already undergone previous C-section

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen who have undergone Cesarean delivery
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • subjects undergone Cesarean delivery;
  • age \>18;
  • voluntary participation to the study;
  • informed consent release.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Salerno, Dept. of Medicine

Baronissi, Campania, 84081, Italy

Location

Related Publications (12)

  • 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):242-247. doi: 10.1097/PRS.0b013e3181f959e8.

    PMID: 21200219RESULT

  • 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.

    PMID: 20927486RESULT

  • 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.

    PMID: 29948103RESULT

  • 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.

    PMID: 7672876RESULT

  • 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.

    PMID: 26044054RESULT

  • 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.

    PMID: 24962057RESULT

  • 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: 10.2174/1381612822666161025144434.

    PMID: 27784253RESULT

  • 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. doi: 10.1111/j.1524-4725.2006.32192.x.

    PMID: 16875470RESULT

  • 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. doi: 10.1039/b417639c. Epub 2005 May 10.

    PMID: 16010345RESULT

  • 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. doi: 10.3109/13880209.2013.826246. Epub 2013 Sep 30.

    PMID: 24074438RESULT

  • Araujo LU, Grabe-Guimaraes 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. doi: 10.1590/s0102-86502010000500014.

    PMID: 20877959RESULT

  • 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.

    PMID: 33101027DERIVED

MeSH Terms

Conditions

Keloid

Interventions

Transdermal Patch

Condition Hierarchy (Ancestors)

Collagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Valeria Conti, PhD

    Department of Medicine,University of Salerno, Baronissi (SA), Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 6, 2019

Study Start

March 2, 2019

Primary Completion

July 30, 2019

Study Completion

July 31, 2019

Last Updated

August 26, 2019

Record last verified: 2019-08

Locations

IT(1)