Dressing Wear Time After Reduction Mammaplasty

Surgical Site Infection Clinical Trial

Official title:

Twenty-four Hours or 6 Days? A Prospective Randomized Trial Comparing Dressing Wear Time After Reduction Mammaplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002391
• Other study ID #: dinter01
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Skin Colonization
• Surgical Site Infection
• Surgical Wound Infection

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