Photobiomodulation as a New Approach for the Treatment of Nipple Traumas

NCT01462019 | Completed Phase 1

• 1 other identifier: 0239.0.213.000-07
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Injuries to the Nipple (Fissures and Cracks) Resulting Breastfeeding

Keywords

nipple trauma; breast feeding; phototherapy; wound healing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain:

Study Arms (2)

Control

NO INTERVENTION

Photobiomodulation

EXPERIMENTAL

Device: Photobiomodulation

Interventions

Photobiomodulation 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.

Photobiomodulation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontifícia Universidade Católica de Minas Gerais: lead

Study Sites (1)

Pontifícia Universidade Católica de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profa., Phd

Study Record Dates

• First Submitted: October 26, 2011
• First Posted: October 28, 2011
• Study Start: February 1, 2006
• Primary Completion: August 1, 2006
• Study Completion: November 1, 2006
• Last Updated: October 28, 2011

Record last verified: 2011-10

Locations

BR (1)