Surgical Site Infection Clinical Trial
Official title:
Twenty-four Hours or 6 Days? A Prospective Randomized Trial Comparing Dressing Wear Time After Reduction Mammaplasty
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 |
Verified date | September 2019 |
Source | Federal University of São Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study was designed to determine whether the duration of dressing wear following reduction mammaplasty influence skin colonization and surgical site infections rates.
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital das Clínicas Samuel Libânio - UNIVÁS | Pouso Alegre | Minas Gerais |
Lead Sponsor | Collaborator |
---|---|
Daniela Francescato Veiga | Universidade do Vale do Sapucai |
Brazil,
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | surgical site infection | 30 days postoperatively | ||
Secondary | skin colonization | 6 days postoperatively |
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