search
Back to results

Time of Permanence of Dressing Following Breast Reconstruction

Primary Purpose

Surgical Site Infection

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Incisions covered for 1 day
Incisions covered for 6 days
Sponsored by
Daniela Francescato Veiga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Surgical Site Infection focused on measuring breast, plastic surgery, bandages, surgical site infection, skin colonization

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital das Clinicas Samuel Libânio, Universidade do Vale do Sapucaí

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Postoperative day 1

Postoperative day 6

Arm Description

Dressing was removed on the first postoperative day

Dressing was removed on the 6th postoperative day

Outcomes

Primary Outcome Measures

Surgical site infection (SSI)
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
Samples are collected to cultures before dressing (control) and at the 6th postoperative day
Patients self assessments
Patients scored dressing wear time with regard to safety, comfort and convenience.

Full Information

First Posted
June 21, 2010
Last Updated
September 3, 2019
Sponsor
Daniela Francescato Veiga
Collaborators
Universidade do Vale do Sapucai
search

1. Study Identification

Unique Protocol Identification Number
NCT01148823
Brief Title
Time of Permanence of Dressing Following Breast Reconstruction
Official Title
Influence of Time of Permanence of Dressing Following Breast Reconstruction on Skin Colonization and on Surgical Site Infection Rates
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 2007 (Actual)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniela Francescato Veiga
Collaborators
Universidade do Vale do Sapucai

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
breast, plastic surgery, bandages, surgical site infection, skin colonization

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Postoperative day 1
Arm Type
Experimental
Arm Description
Dressing was removed on the first postoperative day
Arm Title
Postoperative day 6
Arm Type
Experimental
Arm Description
Dressing was removed on the 6th postoperative day
Intervention Type
Other
Intervention Name(s)
Incisions covered for 1 day
Other Intervention Name(s)
PO1
Intervention Description
Dressing was removed on the first postoperative day.
Intervention Type
Other
Intervention Name(s)
Incisions covered for 6 days
Other Intervention Name(s)
PO6
Intervention Description
Dressing was removed on the 6th postoperative day.
Primary Outcome Measure Information:
Title
Surgical site infection (SSI)
Description
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.
Time Frame
30th postoperative day and one year after operation
Secondary Outcome Measure Information:
Title
Skin colonization
Description
Samples are collected to cultures before dressing (control) and at the 6th postoperative day
Time Frame
6 days postoperatively
Title
Patients self assessments
Description
Patients scored dressing wear time with regard to safety, comfort and convenience.
Time Frame
2 weeks postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela F Veiga, MD, PhD
Organizational Affiliation
Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital das Clinicas Samuel Libânio, Universidade do Vale do Sapucaí
City
Pouso Alegre
State/Province
MG
ZIP/Postal Code
37550000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
23432779
Citation
Veiga DF, Veiga-Filho J, Damasceno CA, Sales EM, Morais TB, Almeida WE, Novo NF, Ferreira LM. Dressing wear time after breast reconstruction: study protocol for a randomized controlled trial. Trials. 2013 Feb 22;14:58. doi: 10.1186/1745-6215-14-58.
Results Reference
background
Citation
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.
Results Reference
result
PubMed Identifier
27911904
Citation
Veiga DF, Damasceno CA, Veiga-Filho J, Paiva LF, Fonseca FE, Cabral IV, Pinto NL, Juliano Y, Ferreira LM. Dressing Wear Time after Breast Reconstruction: A Randomized Clinical Trial. PLoS One. 2016 Dec 2;11(12):e0166356. doi: 10.1371/journal.pone.0166356. eCollection 2016.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4148541/pdf/13063_2014_Article_2203.pdf
Description
Study Protocol

Learn more about this trial

Time of Permanence of Dressing Following Breast Reconstruction

We'll reach out to this number within 24 hrs