Cesarean Section; DehiscenceNCT04046783
Patch With Onion Extract and Allantoin for C-section Scar
An observational study of Cesarean Section; Dehiscence and Scar Keloid, run by University of Salerno at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section; Dehiscence, Scar Keloid, Wound Heal
- What is being tested?
- patch
- Type of treatment
- Medical device
- How many people
- 93 participants
- Where
- 1 siteItaly
- Study dates
- 2 Mar 2019to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- subjects undergone Cesarean delivery;
- age >18;
- voluntary participation to the study;
- informed consent release.
Who cannot join
- age <18
- hypersensitivity to any constituent of the patch;
- pre-term birth, obesity,
- gestational diabetes,
- hypertension,
- infections,
Show all 9Show fewer
- dermatologic diseases
- use of both systemic and topic corticosteroids;
- no informed consent release.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Tolerability of an Overnight 4-week Treatment With Patch Containing Onion Extract and Allantoin for Cesarean Section Scars
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.
Read the 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
- Conditions
- Cesarean Section; Dehiscence, Scar Keloid, Wound Heal
- Being tested
- patch
- Keywords
- Natural products, Wound healing, Cesarean delivery
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patchDevice
an overnight application of a patch containing a standardized quantity of Allium Cepa extract and allantoin on C-section scars over 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start2 Mar 2019
- Primary completion30 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section; DehiscenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salerno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Valeria Conti, University of Salerno
- Investigators
- Valeria Conti, PhD, Principal investigator, Department of Medicine,University of Salerno, Baronissi (SA), Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046783
- Sponsor's protocol ID
- USalerno
- Status last verified
- Aug 2019
- First submitted
- 31 Jul 2019
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21200219Gauglitz 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.
PubMed 20927486Prager 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.
PubMed 29948103Willital 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.
PubMed 7672876Sidgwick 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.
PubMed 26044054Chuangsuwanich 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.
PubMed 24962057Fang 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.
PubMed 27784253Ho 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.
PubMed 16875470Rose 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.
PubMed 16010345Pikula 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.
PubMed 24074438Araujo 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.
PubMed 20877959Conti 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.
PubMed 33101027
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Tolerability of an Overnight 4-week Treatment With Patch Containing Onion Extract and Allantoin for Cesarean Section Scars
- ClinicalTrials.gov ID
- NCT04046783
- Acronym / sponsor ID
- USalerno
- Conditions
- Cesarean Section; Dehiscence, Scar Keloid, Wound Heal
- Keywords
- Natural products, Wound healing, Cesarean delivery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of SalernoUniversity, hospital or other
- Study start
- 2 Mar 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A included subjects without a history of C-section | – | Device: patchGroup 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 | – | Device: patchGroup 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- subjects undergone Cesarean delivery;
- age >18;
- voluntary participation to the study;
- informed consent release.
Key exclusion criteria (9 listed)
- age <18
- hypersensitivity to any constituent of the patch;
- pre-term birth, obesity,
- gestational diabetes,
- hypertension,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patchan overnight application of a patch containing a standardized quantity of Allium Cepa extract and allantoin on C-section scars over 4 weeks. | Device | Group A included subjects without a history of C-section, group B subjects who had already undergone previous C-section |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Results publication: PubMed 21200219Fearmonti 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.
- Results publication: PubMed 20927486Gauglitz 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.
- Results publication: PubMed 29948103Prager 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.
- Results publication: PubMed 7672876Willital 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.
- Results publication: PubMed 26044054Sidgwick 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.
- Results publication: PubMed 24962057Chuangsuwanich 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.
- Results publication: PubMed 27784253Fang 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.
- Results publication: PubMed 16875470Ho 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.
- Results publication: PubMed 16010345Rose 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.
- Results publication: PubMed 24074438Pikula 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.
- Results publication: PubMed 20877959Araujo 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.
- Derived from this study: PubMed 33101027Conti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valeria Conti, PhD principal investigator
Department of Medicine,University of Salerno, Baronissi (SA), Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section; Dehiscence and Scar Keloid, run by University of Salerno at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04046783, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2019; AzTrials last refreshed its copy on 27 Oct 2026.