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Photobiomodulation as a New Approach for the Treatment of Nipple Traumas

NCT ID: NCT01462019

Last Updated: 2011-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Injuries to the Nipple (Fissures and Cracks) Resulting Breastfeeding

Keywords

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nipple trauma breast feeding phototherapy wound healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Photobiomodulation

Group Type EXPERIMENTAL

Photobiomodulation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pontifícia Universidade Católica de Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Angelica Rodrigues de Araujo

Profa., Phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pontifícia Universidade Católica de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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0239.0.213.000-07

Identifier Type: -

Identifier Source: org_study_id