Dressing Wear Time After Reduction Mammaplasty

NCT ID: NCT01002391

Last Updated: 2019-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-09-30

Brief Summary

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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

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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.

Conditions

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Surgical Site Infection Skin Colonization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Postoperative day 1

Dressing is removed on the first postoperative day

Group Type EXPERIMENTAL

reduction mammaplasty

Intervention Type PROCEDURE

Dressing following reduction mammaplasty is removed on the first postoperative day

Postoperative day 6

Dressing is removed on the sixth postoperative day

Group Type EXPERIMENTAL

reduction mammaplasty

Intervention Type PROCEDURE

Dressing following reduction mammaplasty is removed on the sixth postoperative day

Interventions

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reduction mammaplasty

Dressing following reduction mammaplasty is removed on the first postoperative day

Intervention Type PROCEDURE

reduction mammaplasty

Dressing following reduction mammaplasty is removed on the sixth postoperative day

Intervention Type PROCEDURE

Other Intervention Names

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Breast reduction surgery Breast reduction surgery

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidade do Vale do Sapucai

OTHER

Sponsor Role collaborator

Daniela Francescato Veiga

OTHER

Sponsor Role lead

Responsible Party

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Daniela Francescato Veiga

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Joel Veiga-Filho, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Universidade do Vale do Sapucaí and Universidade Federal de São Paulo

Daniela F Veiga, MD, PhD

Role: STUDY_DIRECTOR

Universidade do Vale do Sapucaí and Universidade Federal de São Paulo

Lydia M Ferreira, MD, PhD

Role: STUDY_CHAIR

Universidade do Vale do Sapucaí and Universidade Federal de São Paulo

Locations

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Hospital das Clínicas Samuel Libânio - UNIVÁS

Pouso Alegre, Minas Gerais, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 22186564 (View on PubMed)

Other Identifiers

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dinter01

Identifier Type: -

Identifier Source: org_study_id

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