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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01002391
Other study ID # dinter01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2009
Est. completion date September 2010

Study information

Verified date September 2019
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date September 2010
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Intervention

Procedure:
reduction mammaplasty
Dressing following reduction mammaplasty is removed on the first postoperative day
reduction mammaplasty
Dressing following reduction mammaplasty is removed on the sixth postoperative day

Locations

Country Name City State
Brazil Hospital das Clínicas Samuel Libânio - UNIVÁS Pouso Alegre Minas Gerais

Sponsors (2)

Lead Sponsor Collaborator
Daniela Francescato Veiga Universidade do Vale do Sapucai

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Veiga-Filho J, Veiga DF, Sabino-Neto M, Damasceno CA, Sales EM, 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: 1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary surgical site infection 30 days postoperatively
Secondary skin colonization 6 days postoperatively
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