Effectiveness and Tolerability of a Patch Containing Onion Extract and Allantoin for Cesarean Section Scars

Valeria Conti, Graziamaria Corbi, Teresa Iannaccone, Bianca Corrado, Luigi Giugliano, Serena Lembo, Amelia Filippelli, Maurizio Guida, Valeria Conti, Graziamaria Corbi, Teresa Iannaccone, Bianca Corrado, Luigi Giugliano, Serena Lembo, Amelia Filippelli, Maurizio Guida

Abstract

Background: The prevention or early treatment of pathological scars is the most appropriate therapeutic approach. Gels and patches containing onion extract and allantoin are safe and effective in patients with scars of various origins and severity. However, no controlled studies have evaluated the effects of the patch formulation in women after Cesarean delivery. This study aimed to investigate the effects of a patch containing Allium cepa and allantoin on Cesarean section (C-section) scars.

Methods: This is an observational study. Women were consecutively recruited at the University Hospital of Salerno and subdivided into two groups considering the number of C-section. Group A included subjects without and group B with a history of C-section. Scars assessment was made using digital photographs and the Patient and Observer Scar Assessment Scale (POSAS). After 4 weeks, the C-section of the women who had applied a patch containing Allium cepa and allantoin and those of women who had not used any products (controls) were re-evaluated as at baseline. The Observers independently performed the scars assessment at baseline and after 4 weeks. Data are expressed as the difference of the POSAS scores after 4 weeks minus the POSAS scores at baseline. The statistical significance was established at a p value <0.05.

Results: Ninety-three subjects completed the study (47 in group A and 46 in group B). Women who had used a patch showed an improvement in total score by observer scale when compared with controls (p = 0.013). By the patient scale, no significant changes from baseline were found in group A and group B. Group B with patch showed changes in scars' pigmentation (p = 0.015), relief (p = 0.039), and pliability (p = 0.046) in comparison of controls. Digital photographs confirmed such improvements in women who had already undergone previous C-section, while no significant changes from baseline were found in women without a history of C-section.

Conclusions: Intense treatment of just 4 weeks with a patch containing Alium Cepa extract and allantoin was able to improve pigmentation, relief, and pliability of C-section scars in women with a history of C-section.

Clinical trial registration: ClinicalTrials.gov, identifier NCT04046783.

Keywords: allantoin; cesarean delivery; natural products; onion extract; wound healing.

Copyright © 2020 Conti, Corbi, Iannaccone, Corrado, Giugliano, Lembo, Filippelli and Guida.

Figures

Figure 1
Figure 1
Disposition of women in the study design adapted by the CONSORT algorithm.
Figure 2
Figure 2
Digital photographs of two subjects for each group at baseline and 4 weeks.
Figure 3
Figure 3
(A) The subjects of Group B2 (Previous C-section-Patch) showed a significant improvement (p = 0.012) in the total score according to POSAS Patient scale in comparison with the subjects in group A2 (first C-section-Patch). (B) The subjects in Group B2 showed a significant improvement in total score according to POSAS Observer scale when compared with all other groups (vs. group B1 (Previous C-section-NO patch), p = 0.013; vs. group A2, p = 0.002; vs. group A1 (First C-section- NO Patch), p = 0.007). No other differences were found in Group A.
Figure 4
Figure 4
(A) The subjects in Group B2 (Previous C-section-Patch) showed a significant improvement in pigmentation according to POSAS Observer scale when compared with all other groups (vs. Group B1 (Previous C-section-NO patch), p = 0.015; vs. group A2 (First C-section-Patch), p = 0.002; vs. Group A1 (First C-section- NO Patch), p = 0.045). (B) The subjects in group B2 showed a significant improvement (p = 0.039) in relief according to POSAS observer scale in comparison with the group B1. No other differences were found in group A and between groups. (C) The subjects in group B2 showed a significant improvement (p = 0.046) in pliability according to POSAS Observer scale when compared to the group B1. No other differences were found in group B and between groups.

References

    1. Araújo L. U., Grabe-Guimarães A., Mosqueira V. C., Carneiro C. M., Silva-Barcellos N. M. (2010). Profile of wound healing process induced by allantoin. Acta Cir. Bras. 25, 460. 10.1590/S0102-86502010000500014
    1. Campanati A., Savelli A., Sandroni L., Marconi B., Giuliano A., Giuliodori K., et al. (2010). Effect of allium cepa-allantoin-pentaglycan gel on skin hypertrophic scars: clinical and video-capillaroscopic results of an open-label, controlled, nonrandomized clinical trial. Dermatol. Surg. 36, 1439. 10.1111/j.1524-4725.2010.01654.x
    1. Chuangsuwanich A., Jongjamfa K. (2014). The efficacy of combined herbal extracts gel preparation in the prevention of postsurgical hypertrophic scar formation. Dermatol. Ther. (Heidelb) 4, 187. 10.1007/s13555-014-0055-0
    1. Clark R. A. (2001). Fibrin and wound healing. Ann. N. Y. Acad. Sci. 936, 355. 10.1111/j.1749-6632.2001.tb03522.x
    1. Corbi G., Gambassi G., Pagano G., Russomanno G., Conti V., Rengo G., et al. (2015). Impact of an Innovative Educational Strategy on Medication Appropriate Use and Length of Stay in Elderly Patients. Med. (Baltimore) 94, e918. 10.1097/MD.0000000000000918
    1. Corbi G., Conti V., Davinelli S., Scapagnini G., Filippelli A., Ferrara N. (2016). Dietary Phytochemicals in Neuroimmunoaging: A New Therapeutic Possibility for Humans? Front. Pharmacol. 7, 364. 10.3389/fphar.2016.00364
    1. Corzo-Martínez M., Corzo N., Villamiel M. (2007). Biological properties of onions and garlic. Trends Food Sci. Tech. 18, 609. 10.1016/j.tifs.2007.07.011
    1. Draaijers L. J., Tempelman F. R., Botman Y. A., Tuinebreijer Wim E., Middelkoop E., Kreis R. W., et al. (2004). The patient and observer scar assessment scale: A reliable and feasible tool for scar evaluation. Plast. Reconstr. Surg. 113, 1960–1965. (discussion 1966–1967). 10.1097/01.PRS.0000122207.28773.56
    1. Draelos Z. D., Baumann L., Fleischer A. B., Jr, Plaum S., Avakian E. V., Hardas B. (2012). A new proprietary onion extract gel improves the appearance of new scars: a randomized, controlled, blinded-investigator study. J. Clin. Aesthet. Dermatol. 5 (6), 18–24.
    1. Eming S. A., Krieg T., Davidson J. M. (2007). Inflammation in wound repair: molecular and cellular mechanisms. J. Invest. Dermatol. 127, 514. 10.1038/sj.jid.5700701
    1. Fang Q. Q., Chen C. Y., Zhang M. X., Huang C. L., Wang X. W., Xu J. H., et al. (2017). The Effectiveness of Topical Anti-scarring Agents and a Novel Combined Process on Cutaneous Scar Management. Curr. Pharm. Des. 23, 2268. 10.2174/1381612822666161025144434
    1. Fearmonti R., Bond J., Erdmann D., Levin L., Pizzo S. V., Levinson H. (2011). The Modified POSAS: A Novel Approach to Defining Pathologic and Non-Pathologic Scarring. Plast. Reconstr. Surg. 127, 242. 10.1097/PRS.0b013e3181f959e8
    1. Fitzpatrick T. B. (1975). Soleil et peau. J. Med. Esthet. 2, 33–34.
    1. Forte M., Conti V., Damato A., Ambrosio M., Puca A. A., Sciarretta S., et al. (2016). Targeting Nitric Oxide with Natural Derived Compounds as a Therapeutic Strategy in Vascular Diseases. Oxid. Med. Cell Longev. 2016, 7364138. 10.1155/2016/7364138
    1. Gangemi E. N., Gregori D., Berchialla P., Zingarelli E., Cairo M., Bollero D., et al. (2008). Epidemiology and risk factors for pathologic scarring after burn wounds. Arch. Facial Plast. Surg. 10, 93. 10.1001/archfaci.10.2.93
    1. Gauglitz G. G., Korting H. C., Pavicic T., Ruzicka T., Jeschke M. G. (2011). Hypertrophic scarring and keloids: pathomechanisms and current and emerging treatment strategies. Mol. Med. 17, 113. 10.2119/molmed.2009.00153
    1. Gold M. H., McGuire M., Mustoe T. A., Pusic A., Sachdev M., Waibel J., et al. (2014). Updated international clinical recommendations on scar management: part 2-algorithms for scar prevention and treatment. Dermatol. Surg. 40, 825. 10.1111/dsu.0000000000000050
    1. Guertler A., Schwaiger H., Poetschke J., Steckmeier S., Gauglitz G. (2020). Objective evaluation of an occlusive overnight intensive patch containing onion extract and allantoin for hypertrophic scars. J. Cosmet. Dermatol. 19, 2415–2420. 10.1111/jocd.13561
    1. Hashemzaei M., Delarami Far A., Yari A., Heravi R. E., Tabrizian K., Taghdisi S. M., et al. (2017). Anticancer and apoptosis−inducing effects of quercetin in vitro and in vivo. Oncol. Rep. 38, 819. 10.3892/or.2017.5766
    1. Ho W. S., Ying S. Y., Chan P. C., Chan H. H. (2006). 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. 32, 891. 10.1111/j.1524-4725.2006.32192.x
    1. Idriss N., Maibach H. I. (2009). Scar assessment scales: a dermatologic overview. Skin Res. Technol. 15, 1. 10.1111/j.1600-0846.2008.00327.x
    1. Karagoz H., Yuksel F., Ulkur E., Evinc R. (2009). Comparison of efficacy of silicone gel, silicone gel sheeting, and topical onion extract including heparin and allantoin for the treatment of postburn hypertrophic scars. Burns 35 (8), 1097. 10.1016/j.burns.2009.06.206
    1. Maher S. F., Dorko L., Saliga S. (2012). Linear scar reduction using silicone gel sheets in individuals with normal healing. J. Wound Care 21 (12), 604–6, 608-9. 10.12968/jowc.2012.21.12.602
    1. Manca M. L., Matricardi P., Cencetti C., Peris J. E., Melis V., Carbone C., et al. (2016). Combination of argan oil and phospholipids for the development of an effective liposome-like formulation able to improve skin hydration and allantoin dermal delivery. Int. J. Pharm. 505, 204–211. 10.1016/j.ijpharm.2016.04.008
    1. Mehta M., Branford O. A., Rolfe K. J. (2016). The evidence for natural therapeutics as potential anti-scarring agents in burn-related scarring. Burns Trauma. 4, 15. 10.1186/s41038-016-0040-1
    1. Mylonas I., Klaus Friese K. (2015). Indications for and Risks of Elective Cesarean Section. Dtsch. Arztebl. Int. 112, 489. 10.3238/arztebl.2015.0489
    1. Ocampo-Candiani J., Vázquez-Martínez O. T., Iglesias Benavides J. L., Buske K., Lehn A., Acker C. (2014). The prophylactic use of a topical scar gel containing extract of Allium cepae, allantoin, and heparin improves symptoms and appearance of cesarean-section scars compared with untreated scars. J. Drugs Dermatol. 13, 176.
    1. Owji N., Khademi B., Khalili M. R. (2018). Effectiveness of Topical Onion Extract Gel in the Cosmetic Appearance of Blepharoplasty Scar. J. Clin. Aesthet. Dermatol. 11, 31. 10.1111/j.1524-4725.2006.32192.x
    1. Pikuła M., Żebrowska M. E., Pobłocka-Olech L., Krauze-Baranowska M., Sznitowska M., Trzonkowski P. (2014). Effect of enoxaparin and onion extract on human skin fibroblast cell line - therapeutic implications for the treatment of keloids. Pharm. Biol. 52, 262. 10.3109/13880209.2013.826246
    1. Poole J. H. (2013). Adhesions following cesarean delivery: a review of their occurrence, consequences and preventative management using adhesion barriers. Womens Health (Lond) 9, 467. 10.2217/whe.13.45
    1. Prager W., Gauglitz G. G. (2018). Effectiveness and Safety of an Overnight Patch Containing Allium cepa Extract and Allantoin for Post-Dermatologic Surgery Scars. Aesthetic Plast. Surg. 42, 1144. 10.1007/s00266-018-1172-4
    1. Ramos F. A., Takaishi Y., Shirotori M., Kawaguchi Y., Tsuchiya K., Shibata H., et al. (2006). Antibacterial and antioxidant activities of quercetin oxidation products from yellow onion (Allium cepa) skin. J. Agric. Food Chem. 54, 3551. 10.1021/jf060251c
    1. Rose P., Whiteman M., Moore P. K., Zhu Y. Z. (2005). Bioactive Salk(en)yl cysteine sulfoxide metabolites in the genus Allium: the chemistry of potential therapeutic agents. Nat. Prod. Rep. 22, 351. 10.1039/b417639c
    1. Saleheen D., Ali S. A., Yasinzai M. M. (2004). Antileishmanial activity of aqueous onion extract in vitro. Fitoterapia 75, 9. 10.1016/j.fitote.2003.07.010
    1. Saulis A. S., Mogford J. H., Mustoe T. A. (2002). Effect of Mederma on hypertrophic scarring in the rabbit ear model. Plast. Reconstr. Surg. 110 (1), 177–183. 10.1097/00006534-200207000-00029
    1. Selamoglu Z., Dusgun C., Akgul H., Gulhan M. F. (2017). In-vitro Antioxidant Activities of the Ethanolic Extracts of Some Contained-Allantoin Plants. Iran J. Pharm. Res. 16, 92. 10.22037/IJPR.2017.1993
    1. Sidgwick G. P., McGeorge D., Bayat A. (2015). A comprehensive evidence-based review on the role of topicals and dressings in the management of skin scarring. Arch. Dermatol. Res. 307, 461. 10.1007/s00403-015-1572-0
    1. Tansey M. R., Appleton J. A. (1975). Inhibition of fungal growth by garlic extract. Mycologia 67, 409. 10.1080/00275514.1975.12019761
    1. Truong P. T., Lee J. C., Soer B., Gaul C. A., Olivotto I. A. (2007). Reliability and validity testing of the Patient and Observer Scar Assessment Scale in evaluating linear scars after breast cancer surgery. Plast. Reconstr. Surg. 119 (2), 487–494. 10.1097/01.prs.0000252949.77525.bc
    1. Willital G. H., Heine H. (1994). Efficacy of Contractubex gel in the treatment of fresh scars after thoracic surgery in children and adolescents. Int. J. Clin. Pharmacol. Res. 14, 193.
    1. Willital G. H., Simon J. (2013). Efficacy of early initiation of a gel containing extractum cepae, heparin, and allantoin for scar treatment: an observational, non interventional study of daily practice. J. Drugs Dermatol. 12, 38.

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren