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Photobiomodulation as a New Approach for the Treatment of Nipple Traumas

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01462019
Enrollment
Unknown
Registered
2011-10-28
Start date
2006-02-28
Completion date
2006-11-30
Last updated
2011-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injuries to the Nipple (Fissures and Cracks) Resulting Breastfeeding

Keywords

nipple trauma, breast feeding, phototherapy, wound healing

Brief summary

Inadequate care during pregnancy and postpartum are predisposing factors for the emergence of nipple fissures. The therapeutic approach of nipple trauma care guidelines aimed at the breast and the appropriate techniques for breastfeeding. These measures, however, have a much more preventive than curative, it is not, in most cases, sufficient to power the closing of nipple trauma. The objective of this study was to evaluate the effectiveness of a phototherapy device designed specifically for the treatment of nipple trauma.

Interventions

DEVICEPhotobiomodulation

the participants of this group will receive, in addition to guidance on the breast care and proper techniques for feeding, phototherapy applications through photobiomodulador a device developed specifically for the treatment of nipple injuries. The parameters for applications are: continuous mode of emission, power output 10 mW, wavelength infrared (scanning from 880 to 904 nm) fluence of 4 J / cm ² and total application time of 10 minutes. The application of the device will be three times per week on alternate days for seven consecutive weeks, totaling 21 sessions.

Sponsors

Pontifícia Universidade Católica de Minas Gerais
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years

Inclusion criteria

* women should have a medical diagnosis of nipple trauma were not infected and aged 18 to 35 years

Exclusion criteria

* previous history of cancer; use of other therapeutic modalities that might interfere with the healing of the lesions; presence of infected wounds; history of photosensitivity to light; cognitive deficits that undermine the understanding and implementation of guidelines of care for breast

Design outcomes

Primary

MeasureTime frameDescription
Size and classification of injurieswounds nipple will be measured weekly in the initial assessment and for six consecutive weeks, using a digital caliper and classified at the beginning and end of treatment according to Pereira et al (1998). The measurements and classification of cracks will be conducted by a researcher previously trained to perform procedures.

Secondary

MeasureTime frameDescription
Pain:pain intensity will be evaluated using the Visual Numeric Scale (VNS). The EVN will be applied at baseline and at the beginning of each week of treatment, for six consecutive weeks.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026