We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dressing Wear Time After Reduction Mammaplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01002391
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : March 13, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Surgical Site Infection Skin Colonization Procedure: reduction mammaplasty

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Twenty-four Hours or 6 Days? A Prospective Randomized Trial Comparing Dressing Wear Time After Reduction Mammaplasty
Study Start Date : February 2009
Primary Completion Date : November 2009
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Postoperative day 1
Dressing is removed on the first postoperative day
Procedure: reduction mammaplasty
Dressing following reduction mammaplasty is removed on the first postoperative day
Other Name: Breast reduction surgery
Experimental: Postoperative day 6
Dressing is removed on the sixth postoperative day
Procedure: reduction mammaplasty
Dressing following reduction mammaplasty is removed on the sixth postoperative day
Other Name: Breast reduction surgery


Outcome Measures

Primary Outcome Measures :
  1. surgical site infection [ Time Frame: 30 days postoperatively ]

Secondary Outcome Measures :
  1. skin colonization [ Time Frame: 6 days postoperatively ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002391


Locations
Brazil
Hospital das Clínicas Samuel Libânio - UNIVÁS
Pouso Alegre, Minas Gerais, Brazil, 37550000
Sponsors and Collaborators
Daniela Francescato Veiga
Universidade do Vale do Sapucai
Investigators
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
More Information

Publications:
Responsible Party: Daniela Francescato Veiga, Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01002391     History of Changes
Other Study ID Numbers: dinter01
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: March 13, 2012
Last Verified: March 2012

Keywords provided by Daniela Francescato Veiga, Federal University of São Paulo:
breast hypertrophy
mammaplasty
bandages
surgical site infection
skin colonization

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes