Dressing Wear Time After Breast Augmentation With Prosthesis

Daniela Francescato Veiga

Status: Completed

Conditions: Surgical Site Infection

Treatments: Procedure: augmentation mammaplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT01553604

Micro02

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 months to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups

Postoperative day 6

Experimental group

Description:

Dressing is removed on the sixth postoperative day

Treatment:

Procedure: augmentation mammaplasty

Procedure: augmentation mammaplasty

Postoperative day 1

Experimental group

Description:

Dressing is removed on the first postoperative day

Treatment:

Procedure: augmentation mammaplasty

Procedure: augmentation mammaplasty