Dressing Wear Time After Reduction Mammaplasty

This study has been completed.
Sponsor:
Collaborator:
Universidade do Vale do Sapucai
Information provided by (Responsible Party):
Daniela Francescato Veiga, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01002391
First received: October 23, 2009
Last updated: March 12, 2012
Last verified: March 2012

October 23, 2009
March 12, 2012
February 2009
November 2009   (final data collection date for primary outcome measure)
surgical site infection [ Time Frame: 30 days postoperatively ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01002391 on ClinicalTrials.gov Archive Site
skin colonization [ Time Frame: 6 days postoperatively ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Dressing Wear Time After Reduction Mammaplasty
Twenty-four Hours or 6 Days? A Prospective Randomized Trial Comparing Dressing Wear Time After Reduction Mammaplasty

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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Surgical Site Infection
  • Skin Colonization
  • Procedure: reduction mammaplasty
    Dressing following reduction mammaplasty is removed on the first postoperative day
    Other Name: Breast reduction surgery
  • Procedure: reduction mammaplasty
    Dressing following reduction mammaplasty is removed on the sixth postoperative day
    Other Name: Breast reduction surgery
  • Experimental: Postoperative day 1
    Dressing is removed on the first postoperative day
    Intervention: Procedure: reduction mammaplasty
  • Experimental: Postoperative day 6
    Dressing is removed on the sixth postoperative day
    Intervention: Procedure: reduction mammaplasty
Veiga-Filho J, Veiga DF, Sabino-Neto M, Damasceno CA, Sales EM, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
September 2010
November 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01002391
dinter01
No
Daniela Francescato Veiga, Federal University of São Paulo
Daniela Francescato Veiga
Universidade do Vale do Sapucai
Principal Investigator: Joel Veiga-Filho, MD, MSc Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
Study Director: Daniela F Veiga, MD, PhD Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
Study Chair: Lydia M Ferreira, MD, PhD Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
Federal University of São Paulo
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP