Dressing Wear Time After Breast Augmentation With Prosthesis

Not Applicable

Completed

• Conditions: Surgical Site Infection
• Interventions: Procedure: augmentation mammaplasty

• Registration Number: NCT01553604
• Lead Sponsor: Daniela Francescato Veiga

Brief Summary

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

Detailed Description

Augmentation mammaplasty is currently one of the most performed plastic surgery procedures. It is a clean operation, and surgical site infection (SSI) rates are low. However, a SSI, since a minor one, leads to the failure of the procedure. Thus, minimizing SSI risks is imperative.

The Centers for Disease Control and Prevention (CDC) provides recommendations concerning prevention of SSI.No recommendation is offered for some practices, either because there is a lack of consensus regarding their efficacy or because of the available scientific evidence is insufficient to support their adoption.

CDC´s "Guideline for Prevention of Surgical Site Infection" recommends protecting with a sterile dressing for 24 to 48 hours an incision that has been closed primarily. There is no recommendation to cover the incision beyond 48 hours. One major risk factor for SSI is the presence of bacteria at surgical site.Thus, this trial was designed to verify the influence of dressing wear time on skin colonization.

Study Timeline

• Study First Submitted: 2012-03-12
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-14
• Study Start: 2013-07
• Primary Completion: 2015-01
• Study Completion: 2015-09
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• candidate to breast prosthesis implantation
• 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postoperative day 6	augmentation mammaplasty	Dressing is removed on the sixth postoperative day
Postoperative day 1	augmentation mammaplasty	Dressing is removed on the first postoperative day

Primary Outcome Measures

Name	Time	Method
skin colonization	6 days postoperatively	skin colonization will be measured through semi-quantitative cultures of samples collected pre-dressing and on 6th postoperative day.

Secondary Outcome Measures

Name	Time	Method
surgical site infection	30 days postoperatively	Surgical site infection will be assessed weekly, for 30 days. CDC´s criteria and definitions will be used.

Trial Locations

Locations (1)

Hospital das Clínicas Samuel Libanio; 🇧🇷 Pouso Alegre, Minas Gerais, Brazil