Comparison of two treatments of wounds in the nipples of breastfeeding women

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-6dh6cm
• Date of registration: 25/10/2012
• Primary sponsor: Faculdade de Enfermagem da Universidade Federal de Goiás - Goiânia, GO, Brazil
• Public title: Comparison of two treatments of wounds in the nipples of breastfeeding women
• Scientific title: Clinical trial for the management of nipple trauma on breastfeeding
• Date of first enrolment: 16/10/2011
• Target sample size: 100
• Recruitment status: recruitment completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-6dh6cm/
• Study design: Randomized controlled trail, double-arm, open. Study of the type of intervention, with treatment approach.

Countries of recruitment

Brazil

Contacts

• Name: Flaviana Vieira
• Affiliation: Faculdade de Enfermagem da Universidade Federal de Goiás

• Name: Flaviana Vieira
• Affiliation: Faculdade de Enfermagem da Universidade Federal de Goiás

Key inclusion & exclusion criteria

Inclusion criteria: Woman in exclusive breastfeeding; have old 18 years or more; having given birth to infants who are able to be breastfed; have a telephone for contact; presenting clinical evidence of detectable macroscopically unilateral or bilateral nipple trauma in the period up to day 10 postpartum.

Exclusion criteria: Health problems that interfere with the healing process; anatomical changes that favor the nipples nipple trauma (inverted nipple, inverted nipple pseudo); residence outside the city of Goiania - GO.

Age minimum: 18Y
Age maximum: 0
Gender: F

Health Condition(s) or Problem(s) studied

Nipple trauma in breastfeeding
F01.145.407.199

Intervention(s)

A randomized controlled trial, unblinded. Study focusing on the type of treatment intervention. The sample consists of 100 mothers, in breastfeeding in the maternity, with nipple trauma unilateral or bilateral, being allocated in group 1 or 2, after the randomization, by lot with a sealed envelope containing the intervention 1 or intervention 2. The minimum age of woman for inclusion in the study was 18 years and was not given the maximum age. The group 1 (50 women) applying of anhydrous lanolin in nipple trauma (fatty substance that because their properties to maintain a barrier that prevents loss of natural moisture of the skin layers, has been recommended for the healing of nipple traumas) after each feeding.Group 2 (50 women): applying 3 to 4 drops of breast milk (composed of antibodies (IgA) and inflammatory cells that help in the healing of the lesion) after each feeding, with clean hands and put breast nipple shell (not flexible plastic device that provides a barrier of protection from friction and / or pressure garments overlaid and other contacts the skin of the nipple, with passage of air for aeration of the breast). Both groups received counseling for breastfeeding. The women received daily monitoring by a nurse midwife, and the 2nd, 4th, 6th, 8th and 9th day of treatment by telephone and on the 1st, 3rd, 5th, 7th and 10th day of treatment, direct assessment, in home visit. Evaluation of healing of nipple trauma in both groups was determined by the Nipple Trauma Score (NTS) on a scale of zero to five. This scale represents zero: nNo microscopically visible skin changes; 1 Erythema or edema or combination of both; 2 Superficial damage with or without scab formation of less than 25% of the nipple surface; 3 Superficial damage with or without scab formation of more than 25% of the nipple surface; 4 Partial-thickness wound with or without scab formation of less than 25% of the nipple surface; 5 Partial-thickness wound with or without scab formation of more

Primary Outcome(s)

It is expected that the more rapid healing present in one of the groups, in other words, zero is the most frequent and appears faster in one group.

Secondary Outcome(s)

It is hoped that the present numeric pain scale values decrease faster in one of two groups, each day of monitoring.

Secondary ID(s)

055/2011

Source(s) of Monetary Support

Fundação de Amparo à Pesquisa do Estado de Goiás (FAPEG) - Goiânia, GO, Brazil

Secondary Sponsor(s)

GESMAC - Grupo de Estudo em Saúde da Mulher, do Adolescente e da Criança - Goiânia, GO, Brazil