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Completed

NCT Number: NCT01002391

Dressing Wear Time After Reduction Mammaplasty

This study was designed to determine whether the duration of dressing wear following reduction mammaplasty influence skin colonization and surgical site infections rates.

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Key information

Conditions

Surgical Site Infection Gigantomastia Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Skin Colonization Surgical Wound Infection Wound Infection

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas Samuel Libânio - UNIVÁS

Pouso Alegre, Minas Gerais, 37550000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

reduction mammaplasty

Procedure

Dressing following reduction mammaplasty is removed on the first postoperative day

Other names: Breast reduction surgery

Primary outcomes

  1. surgical site infection

    Time frame: 30 days postoperatively

Secondary outcomes

  1. skin colonization

    Time frame: 6 days postoperatively

Sponsors and collaborators

Lead sponsor

Daniela Francescato Veiga

Other

Collaborators

  • Universidade do Vale do Sapucai

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Oct 27, 2009
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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