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Time of Permanence of Dressing Following Breast Reconstruction

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:
NCT01148823
First received: June 21, 2010
Last updated: October 25, 2014
Last verified: October 2014
  Purpose

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 Intervention
Surgical Site Infection
Procedure: Incisions covered for 1 day
Procedure: Incisions covered for 6 days

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Influence of Time of Permanence of Dressing Following Breast Reconstruction on Skin Colonization and on Surgical Site Infection Rates

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Surgical site infection (SSI) [ Time Frame: 30th postoperative day and one year after operation ] [ Designated as safety issue: No ]
    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:
  • Skin colonization [ Time Frame: 6 days postoperatively ] [ Designated as safety issue: No ]
    Samples are collected to cultures before dressing (control) and at the 6th postoperative day

  • Patients self assessments [ Time Frame: 2 weeks postoperatively ] [ Designated as safety issue: No ]
    Patients scored dressing wear time with regard to safety, comfort and convenience.


Enrollment: 200
Study Start Date: June 2007
Study Completion Date: October 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Postoperative day 1
Dressing was removed on the first postoperative day
Procedure: 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
Procedure: Incisions covered for 6 days
Dressing was removed on the 6th postoperative day.
Other Name: PO6

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01148823

Locations
Brazil
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
Investigators
Study Chair: Daniela F Veiga, MD, PhD Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
  More Information

Additional Information:
Publications:
Responsible Party: Daniela Francescato Veiga, Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01148823     History of Changes
Other Study ID Numbers: Micro01
Study First Received: June 21, 2010
Last Updated: October 25, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
breast
plastic surgery
bandages
surgical site infection
skin colonization

Additional relevant MeSH terms:
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on November 25, 2014