Photobiomodulation as a New Approach for the Treatment of Nipple Traumas

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.

Study Overview

• Status: Completed
• Conditions: Injuries to the Nipple (Fissures and Cracks) Resulting Breastfeeding
• Intervention / Treatment: Device: Photobiomodulation

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil
      • Pontifícia Universidade Católica de Minas Gerais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: Photobiomodulation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
Size and classification of injuries	wounds 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 Outcome Measures

Outcome Measure	Measure Description
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.

Collaborators and Investigators

• Sponsor: Pontifícia Universidade Católica de Minas Gerais

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (ACTUAL): August 1, 2006
• Study Completion (ACTUAL): November 1, 2006

Study Registration Dates

• First Submitted: October 26, 2011
• First Submitted That Met QC Criteria: October 26, 2011
• First Posted (ESTIMATE): October 28, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 28, 2011
• Last Update Submitted That Met QC Criteria: October 26, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: phototherapy; wound healing; breast feeding; nipple trauma
• Other Study ID Numbers: 0239.0.213.000-07