Clinical trial NCT01553604: Dressing Wear Time After Breast Augmentation With Prosthesis
Official title: Influence of Dressing Wear Time on Skin Colonization After Breast Augmentation With Prosthesis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Keywords: breast prosthesis implantation
bandages
skin colonization
surgical site infection
augmentation mammaplasty
dressing wear time
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was designed to determine whether the duration of dressing wear following augmentation mammaplasty influence skin colonization and eventually surgical site infections rates.

Detailed description: Augmentation mammaplasty is currently one of the most performed plastic surgery procedures. It is a clean operation, and surgical site infection (SSI) rates are low. However, a SSI, since a minor one, leads to the failure of the procedure. Thus, minimizing SSI risks is imperative.

The Centers for Disease Control and Prevention (CDC) provides recommendations concerning prevention of SSI.No recommendation is offered for some practices, either because there is a lack of consensus regarding their efficacy or because of the available scientific evidence is insufficient to support their adoption.

CDC´s "Guideline for Prevention of Surgical Site Infection" recommends protecting with a sterile dressing for 24 to 48 hours an incision that has been closed primarily. There is no recommendation to cover the incision beyond 48 hours. One major risk factor for SSI is the presence of bacteria at surgical site.Thus, this trial was designed to verify the influence of dressing wear time on skin colonization.

Eligibility criteria: Inclusion Criteria:

* candidate to breast prosthesis implantation
* body mass index under 30Kg/m2

Exclusion Criteria:

* pregnancy, delivery or breast feeding during the last 12 months
* body mass index over 30Kg/m2
* breast cancer history
* previous breast surgery
* hard smoking

Primary outcomes:
measure: skin colonization
timeFrame: 6 days postoperatively
Secondary outcomes:
measure: surgical site infection
timeFrame: 30 days postoperatively
Other outcomes:
Locations:
city: Pouso Alegre
country: Brazil
facility: Hospital das Clínicas Samuel Libanio
state: Minas Gerais
Study officials:
affiliation: Universidade Federal de São Paulo
name: Daniela F Veiga, MD, PhD
role: STUDY_DIRECTOR
affiliation: Universidade do Vale do Sapucaí
name: Joel Veiga-Filho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de São Paulo
name: Lydia M Ferreira, MD, PhD
role: STUDY_CHAIR
affiliation: Universidade Federal de São Paulo
name: Denise A Mendes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mendes Dde A, Veiga DF, Veiga-Filho J, Fonseca FE, de Paiva LF, Novo NF, Loyola AB, Ferreira LM. Application time for postoperative wound dressing following breast augmentation with implants: study protocol for a randomized controlled trial. Trials. 2015 Jan 27;16:19. doi: 10.1186/s13063-014-0529-5.
citation: Mendes DA, Veiga DF, Veiga-Filho J, Loyola ABAT, Paiva LF, Novo NF, Sabino-Neto M, Ferreira LM. Influence of dressing application time after breast augmentation on cutaneous colonization: A randomized clinical trial. J Plast Reconstr Aesthet Surg. 2018 Jun;71(6):906-912. doi: 10.1016/j.bjps.2018.01.021. Epub 2018 Feb 21.