Clinical trial NCT01002391: Dressing Wear Time After Reduction Mammaplasty
Official title: Twenty-four Hours or 6 Days? A Prospective Randomized Trial Comparing Dressing Wear Time After Reduction Mammaplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Skin Colonization
Keywords: breast hypertrophy
mammaplasty
bandages
surgical site infection
skin colonization
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Universidade do Vale do Sapucai
First posted: 2009-10-27
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: Surgical site infections (SSI) are wound infections that occur after invasive procedures.Particularly in plastic surgery procedures, to minimize the risk of SSI is imperative, since even minor infections are able to complicate the healing process and harm the cosmetic result.

Reduction mammaplasty is an effective and well established procedure performed for the relief of physical pain and discomfort associated with macromastia, which significantly decreases patients' quality of life.Breast reduction has provided long-term relief for most patients, with high patient satisfaction.

The demand for this kind of plastic surgery is high.Reduction mammaplasty was the fifth most commonly surgical procedure performed by plastic surgeons in women of United States.Since reduction mammaplasty is associated with a high incidence of wound problems,all effort to minimize the risk of SSI is valid.

Eligibility criteria: Inclusion Criteria:

* breast hypertrophy
* candidate to reduction mammaplasty
* 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: surgical site infection
timeFrame: 30 days postoperatively
Secondary outcomes:
measure: skin colonization
timeFrame: 6 days postoperatively
Other outcomes:
Locations:
city: Pouso Alegre
country: Brazil
facility: Hospital das Clínicas Samuel Libânio - UNIVÁS
state: Minas Gerais
Study officials:
affiliation: Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
name: Joel Veiga-Filho, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
name: Daniela F Veiga, MD, PhD
role: STUDY_DIRECTOR
affiliation: Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
name: Lydia M Ferreira, MD, PhD
role: STUDY_CHAIR
References:
citation: Veiga-Filho J, Veiga DF, Sabino-Neto M, Damasceno CAV, Sales EML, Garcia ES, Oliveira IB, De Simoni LF, Juliano Y, Ferreira LM. Dressing wear time after reduction mammaplasty: a randomized controlled trial. Plast Reconstr Surg. 2012 Jan;129(1):1e-7e. doi: 10.1097/PRS.0b013e3182361ee9.