Surgical Site Infection
Conditions
Keywords
breast prosthesis implantation, bandages, skin colonization, surgical site infection, augmentation mammaplasty, dressing wear time
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.
Interventions
PROCEDUREaugmentation mammaplasty
Dressing is removed on the first postoperative day
Sponsors
Daniela Francescato Veiga
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Months to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| surgical site infection | 30 days postoperatively | Surgical site infection will be assessed weekly, for 30 days. CDC´s criteria and definitions will be used. |
Countries
Brazil
Outcome results
None listed