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Dressing Wear Time After Reduction Mammaplasty

Primary Purpose

Surgical Site Infection, Skin Colonization

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

reduction mammaplasty

About this trial

This is an interventional supportive care trial for Surgical Site Infection focused on measuring breast hypertrophy, mammaplasty, bandages, surgical site infection, skin colonization

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Hospital das Clínicas Samuel Libânio - UNIVÁS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Postoperative day 1

Postoperative day 6

Arm Description

Dressing is removed on the first postoperative day

Dressing is removed on the sixth postoperative day

Outcomes

Primary Outcome Measures

surgical site infection

Secondary Outcome Measures

skin colonization

Full Information

NCT ID

NCT01002391

First Posted

October 23, 2009

Last Updated

September 3, 2019

Sponsor

Daniela Francescato Veiga

Collaborators

Universidade do Vale do Sapucai

1. Study Identification

Unique Protocol Identification Number

NCT01002391

Brief Title

Dressing Wear Time After Reduction Mammaplasty

Official Title

Twenty-four Hours or 6 Days? A Prospective Randomized Trial Comparing Dressing Wear Time After Reduction Mammaplasty

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

September 2010 (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

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Site Infection, Skin Colonization

Keywords

breast hypertrophy, mammaplasty, bandages, surgical site infection, skin colonization

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Postoperative day 1

Arm Type

Experimental

Arm Description

Dressing is removed on the first postoperative day

Arm Title

Postoperative day 6

Arm Type

Experimental

Arm Description

Dressing is removed on the sixth postoperative day

Intervention Type

Procedure

Intervention Name(s)

reduction mammaplasty

Other Intervention Name(s)

Breast reduction surgery

Intervention Description

Dressing following reduction mammaplasty is removed on the first postoperative day

Intervention Type

Procedure

Intervention Name(s)

reduction mammaplasty

Other Intervention Name(s)

Breast reduction surgery

Intervention Description

Dressing following reduction mammaplasty is removed on the sixth postoperative day

Primary Outcome Measure Information:

Title

surgical site infection

Time Frame

30 days postoperatively

Secondary Outcome Measure Information:

Title

skin colonization

Time Frame

6 days postoperatively

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joel Veiga-Filho, MD, MSc

Organizational Affiliation

Universidade do Vale do Sapucaí and Universidade Federal de São Paulo

Official's Role

Principal Investigator

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 Director

First Name & Middle Initial & Last Name & Degree

Lydia M Ferreira, 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 Clínicas Samuel Libânio - UNIVÁS

City

Pouso Alegre

State/Province

Minas Gerais

ZIP/Postal Code

37550000

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

22186564

Citation

Veiga-Filho J, Veiga DF, Sabino-Neto M, Damasceno CAV, Sales EML, Garcia ES, Oliveira IB, De Simoni LF, Juliano Y, Ferreira LM. Dressing wear time after reduction mammaplasty: a randomized controlled trial. Plast Reconstr Surg. 2012 Jan;129(1):1e-7e. doi: 10.1097/PRS.0b013e3182361ee9.

Results Reference

result

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Dressing Wear Time After Reduction Mammaplasty

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