Time of Permanence of Dressing Following Breast Reconstruction

September 3, 2019 updated by: Daniela Francescato Veiga

Influence of Time of Permanence of Dressing Following Breast Reconstruction on Skin Colonization and on Surgical Site Infection Rates

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • MG
      • Pouso Alegre, MG, Brazil, 37550000
        • Hospital das Clinicas Samuel Libânio, Universidade do Vale do Sapucaí

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • PO6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30th postoperative day and one year after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin colonization
Time Frame: 6 days postoperatively
Samples are collected to cultures before dressing (control) and at the 6th postoperative day
6 days postoperatively
Patients self assessments
Time Frame: 2 weeks postoperatively
Patients scored dressing wear time with regard to safety, comfort and convenience.
2 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniela Francescato Veiga

Collaborators

Universidade do Vale do Sapucai

Investigators

  • Study Chair: Daniela F Veiga, MD, PhD, Universidade do Vale do Sapucaí and Universidade Federal de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2007

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

June 21, 2010

First Submitted That Met QC Criteria

June 21, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Micro01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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