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Completed

NCT Number: NCT01553604

Dressing Wear Time After Breast Augmentation With Prosthesis

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

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Key information

Conditions

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

Age range

18 month–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas Samuel Libanio

Pouso Alegre, Minas Gerais, 37550000, Brazil

About this study

Augmentation mammaplasty is currently one of the most performed plastic surgery procedures. It is a clean operation, and surgical site infection (SSI) rates are low. However, a SSI, since a minor one, leads to the failure of the procedure. Thus, minimizing SSI risks is imperative.

The Centers for Disease Control and Prevention (CDC) provides recommendations concerning prevention of SSI.No recommendation is offered for some practices, either because there is a lack of consensus regarding their efficacy or because of the available scientific evidence is insufficient to support their adoption.

CDC´s "Guideline for Prevention of Surgical Site Infection" recommends protecting with a sterile dressing for 24 to 48 hours an incision that has been closed primarily. There is no recommendation to cover the incision beyond 48 hours. One major risk factor for SSI is the presence of bacteria at surgical site.Thus, this trial was designed to verify the influence of dressing wear time on skin colonization.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • candidate to breast prosthesis implantation
  • 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

augmentation mammaplasty

Procedure

Dressing is removed on the first postoperative day

Primary outcomes

  1. skin colonization

    Time frame: 6 days postoperatively

    skin colonization will be measured through semi-quantitative cultures of samples collected pre-dressing and on 6th postoperative day.

Secondary outcomes

  1. surgical site infection

    Time frame: 30 days postoperatively

    Surgical site infection will be assessed weekly, for 30 days. CDC´s criteria and definitions will be used.

Sponsors and collaborators

Lead sponsor

Daniela Francescato Veiga

Other

Registry information

Official study title

Influence of Dressing Wear Time on Skin Colonization After Breast Augmentation With Prosthesis: a Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 14, 2012
Registry last updated
Sep 6, 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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