Time of Permanence of Dressing Following Breast Reconstruction

NCT ID: NCT01148823

Last Updated: 2019-09-06

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Postoperative day 1

Dressing was removed on the first postoperative day

Group Type EXPERIMENTAL

Incisions covered for 1 day

Intervention Type OTHER

Dressing was removed on the first postoperative day.

Postoperative day 6

Dressing was removed on the 6th postoperative day

Group Type EXPERIMENTAL

Incisions covered for 6 days

Intervention Type OTHER

Dressing was removed on the 6th postoperative day.

Interventions

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Incisions covered for 1 day

Dressing was removed on the first postoperative day.

Intervention Type OTHER

Incisions covered for 6 days

Dressing was removed on the 6th postoperative day.

Intervention Type OTHER

Other Intervention Names

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PO1 PO6

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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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Daniela F Veiga, MD, PhD

Role: STUDY_CHAIR

Universidade do Vale do Sapucaí and Universidade Federal de São Paulo

Locations

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Hospital das Clinicas Samuel Libânio, Universidade do Vale do Sapucaí

Pouso Alegre, Minas Gerais, Brazil

Site Status

Countries

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Brazil

References

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Veiga DF, Veiga-Filho J, Damasceno CA, Sales EM, Morais TB, Almeida WE, Novo NF, Ferreira LM. Dressing wear time after breast reconstruction: study protocol for a randomized controlled trial. Trials. 2013 Feb 22;14:58. doi: 10.1186/1745-6215-14-58.

Reference Type BACKGROUND
PMID: 23432779 (View on PubMed)

Veiga DF, Veiga-Filho J, Mendes DA, Sales AM, Damasceno Ca, Ferreira LM. Dressing wear time after breast reconstruction: preliminary results of a randomized controlled trial. Plastic and Reconstructive Surgery 131(5S): 119, 2013.

Reference Type RESULT

Veiga DF, Damasceno CA, Veiga-Filho J, Paiva LF, Fonseca FE, Cabral IV, Pinto NL, Juliano Y, Ferreira LM. Dressing Wear Time after Breast Reconstruction: A Randomized Clinical Trial. PLoS One. 2016 Dec 2;11(12):e0166356. doi: 10.1371/journal.pone.0166356. eCollection 2016.

Reference Type RESULT
PMID: 27911904 (View on PubMed)

Related Links

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Other Identifiers

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Micro01

Identifier Type: -

Identifier Source: org_study_id

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