Injuries to the Nipple (Fissures and Cracks) Resulting BreastfeedingPhase 1/2NCT01462019
Photobiomodulation as a New Approach for the Treatment of Nipple Traumas
A Phase 1/2 study testing Photobiomodulation in people with Injuries to the Nipple (Fissures and Cracks) Resulting Breastfeeding, run by Pontifícia Universidade Católica de Minas Gerais at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Injuries to the Nipple (Fissures and Cracks) Resulting Breastfeeding
- What is being tested?
- Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteBrazil
- Study dates
- Feb 2006to Nov 2006
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Adult
Who may be able to join
- women should have a medical diagnosis of nipple trauma were not infected and aged 18 to 35 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Pontifícia Universidade Católica de Minas Gerais
Belo Horizonte, Minas Gerais
About this study
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.
- Being tested
- Photobiomodulation
- Keywords
- nipple trauma, breast feeding, phototherapy, wound healing
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Photobiomodulation | Experimental | Not described Receives: Device: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startFeb 2006
- Primary completionAug 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injuries to the Nipple (Fissures and Cracks) Resulting BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Pontifícia Universidade Católica de Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelica Rodrigues de Araujo, Pontifícia Universidade Católica de Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462019
- Sponsor's protocol ID
- 0239.0.213.000-07
- Status last verified
- Oct 2011
- First submitted
- 26 Oct 2011
- Last updated
- 28 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation as a New Approach for the Treatment of Nipple Traumas
- ClinicalTrials.gov ID
- NCT01462019
- Acronym / sponsor ID
- 0239.0.213.000-07
- Keywords
- nipple trauma, breast feeding, phototherapy, wound healing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Pontifícia Universidade Católica de Minas GeraisUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 28 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Photobiomodulation | Experimental | Device: Photobiomodulation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women should have a medical diagnosis of nipple trauma were not infected and aged 18 to 35 years
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulationthe 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. | Device | Photobiomodulation |
Primary outcome
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.
1 secondary outcome
Pain:
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Photobiomodulation in people with Injuries to the Nipple (Fissures and Cracks) Resulting Breastfeeding, run by Pontifícia Universidade Católica de Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size and classification of injuries. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2011.