We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Time of Permanence of Dressing Following Breast Reconstruction

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: NCT01148823
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : February 24, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
This randomized clinical trial was designed to assess the influence of time of dressing after breast reconstruction procedures on surgical site infections rates and skin colonization.

Condition or disease Intervention/treatment
Surgical Site Infection Other: Incisions covered for 1 day Other: Incisions covered for 6 days

Detailed Description:

The rates of surgical site infections (SSI) after clean operations range from 1 to 2%. However, infection rates in the breast surgical literature tend to be higher, with reported rates ranging from 2 to 30%. In plastic surgery operations, to minimize the risk of SSI is imperative, since even minor infections are able to complicate the healing process and harm the cosmetic result.

The Centers for Disease Control and Prevention has established guidelines for postoperative incision care. However, there is no recommendation to cover an incision closed primarily beyond 48 hours, nor on the appropriate time to shower or bathe with an uncovered incision. This remains an unresolved issue.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Official Title: Influence of Time of Permanence of Dressing Following Breast Reconstruction on Skin Colonization and on Surgical Site Infection Rates
Study Start Date : June 2007
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Postoperative day 1
Dressing was removed on the first postoperative day
Other: Incisions covered for 1 day
Dressing was removed on the first postoperative day.
Other Name: PO1
Experimental: Postoperative day 6
Dressing was removed on the 6th postoperative day
Other: Incisions covered for 6 days
Dressing was removed on the 6th postoperative day.
Other Name: PO6

Outcome Measures

Primary Outcome Measures :
  1. Surgical site infection (SSI) [ Time Frame: 30th postoperative day and one year after operation ]
    Patients are followed weekly by a masked surgeon in regard to SSI, until the 30th postoperative day.CDC's criteria and classification was adopted.Patients are reevaluated at the end of the first year after operation.

Secondary Outcome Measures :
  1. Skin colonization [ Time Frame: 6 days postoperatively ]
    Samples are collected to cultures before dressing (control) and at the 6th postoperative day

  2. Patients self assessments [ Time Frame: 2 weeks postoperatively ]
    Patients scored dressing wear time with regard to safety, comfort and convenience.

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 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

•candidate to immediate or delayed breast reconstruction after mastectomy or segmental mastectomy

Exclusion Criteria:

  • use of antibiotics at the time of the operation
  • presence of skin lesions on the surgical site
  • body mass index over 35Kg/m2
  • 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): NCT01148823

Hospital das Clinicas Samuel Libânio, Universidade do Vale do Sapucaí
Pouso Alegre, MG, Brazil, 37550000
Sponsors and Collaborators
Daniela Francescato Veiga
Universidade do Vale do Sapucai
Study Chair: Daniela F Veiga, MD, PhD Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
More Information

Additional Information:
Veiga DF, Veiga-Filho J, Mendes DA, Sales AM, Damasceno Ca, Ferreira LM. Dressing wear time after breast reconstruction: preliminary results of a randomized controlled trial. Plastic and Reconstructive Surgery 131(5S): 119, 2013.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniela Francescato Veiga, Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01148823     History of Changes
Other Study ID Numbers: Micro01
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: February 2015

Keywords provided by Daniela Francescato Veiga, Federal University of São Paulo:
plastic surgery
surgical site infection
skin colonization

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