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Photobiomodulation as a New Approach for the Treatment of Nipple Traumas

NCT01462019 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2011-10-28

No results posted yet for this study

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.

Conditions

  • Injuries to the Nipple (Fissures and Cracks) Resulting Breastfeeding

Interventions

DEVICE

Photobiomodulation

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 & Collaborators

  • Pontifícia Universidade Católica de Minas Gerais

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2006-08-31
Completion
2006-11-30

Countries

  • Brazil

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 NCT01462019 on ClinicalTrials.gov