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Completed

NCT Number: NCT01148823

Time of Permanence of Dressing Following Breast Reconstruction

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.

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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 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clinicas Samuel Libânio, Universidade do Vale do Sapucaí

Pouso Alegre, Minas Gerais, 37550000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Incisions covered for 1 day

Other

Dressing was removed on the first postoperative day.

Other names: PO1

Incisions covered for 6 days

Other

Dressing was removed on the 6th postoperative day.

Other names: PO6

Primary outcomes

  1. Surgical site infection (SSI)

    Time frame: 30th postoperative day and one year after operation

    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 outcomes

  1. Skin colonization

    Time frame: 6 days postoperatively

    Samples are collected to cultures before dressing (control) and at the 6th postoperative day

  2. Patients self assessments

    Time frame: 2 weeks postoperatively

    Patients scored dressing wear time with regard to safety, comfort and convenience.

Sponsors and collaborators

Lead sponsor

Daniela Francescato Veiga

Other

Collaborators

  • Universidade do Vale do Sapucai

Registry information

Official study title

Influence of Time of Permanence of Dressing Following Breast Reconstruction on Skin Colonization and on Surgical Site Infection Rates

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Jun 22, 2010
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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