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The Use of Arnica Montana in the Cicatrization of the Umbilical Cord

NCT05958251 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 326

Last updated 2024-09-19

No results posted yet for this study

Summary

Neonatal infections are still one of the leading causes of mortality among newborns worldwide. For example, omphalitis is particularly common and can lead to the development of neonatal sepsis. This pathology more frequently affects developing countries, where hygienic conditions are often precarious, but the incidence of this disease should not be underestimated even in developed countries. Therefore, it is essential to properly care for the umbilical stump during the first days of life to prevent infections, both in the hospital and at home.

The complications related to poor hygiene of the umbilical stump can be more or less serious. Mild complications include wet stumps, purulent secretions, granulomas, or periumbilical erythema. The most serious complications involve infections of the umbilical cord stump which can manifest locally or systemically, causing respectively omphalitis or neonatal sepsis. Despite the numerous benefits that derive from proper umbilical cord care, the most suitable approach remains controversial and several modalities of care have been described.

The World Health Organization suggests two techniques depending on the neonatal mortality rate. In developed countries the use of dry cord care is recommended while in countries with a high neonatal mortality rate (\>30 deaths/1000 live births) the topical application of antiseptics, such as chlorhexidine, is recommended. Recent studies have focused on the possible advantages of using natural products of plant origin, whose natural anti-inflammatory and dermal protective action is known. Among them, the anti-inflammatory, antibacterial and immunomodulatory properties of arnica montana have been studied and it has been shown that the use of a powder containing this plant extract reduces parental stress and drop time of the umbilical cord stump. However, there is little evidence demonstrating the lower rate of mild to moderate complications resulting from umbilical cord stump care with this product.

Conditions

  • Umbilical Cord Issue

Interventions

OTHER

Cicaben

Cicaben® powder is an association of special active ingredients for topical dermatological use with a healing, soothing and protective action (zinc oxide, magnesium oxide, corn starch, arnica montana extract, allantoin and undecylenic acid, arginine, glycine and proline, niacinamide).

OTHER

Standard Care (in control arm)

Standard care

Sponsors & Collaborators

  • Ospedale Buon Consiglio Fatebenefratelli

    lead OTHER

Principal Investigators

  • Giuseppe De Bernardo, MD · Ospedale Buon Consiglio Fatebenefratelli

Eligibility

Min Age
35 Weeks
Max Age
42 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-30
Primary Completion
2022-11-02
Completion
2022-11-02

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05958251 on ClinicalTrials.gov