Photobiomodulation as a New Approach for the Treatment of Nipple Traumas

Injuries to the Nipple (Fissures and Cracks) Resulting Breastfeeding Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01462019
• Other study ID #: 0239.0.213.000-07
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 26, 2011
• Last updated: October 26, 2011
• Start date: February 2006
• Est. completion date: November 2006

Study information

• Verified date: October 2011
• Source: Pontifícia Universidade Católica de Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2006
• Est. primary completion date: August 2006
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Brazil	Pontifícia Universidade Católica de Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Pontifícia Universidade Católica de Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No
Secondary	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.		No