Dressing Wear Time After Breast Augmentation With Prosthesis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Influence of Dressing Wear Time on Skin Colonization After Breast Augmentation With Prosthesis: a Randomized Controlled Trial

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Procedure: augmentation mammaplasty
* Procedure: augmentation mammaplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postoperative day 6<br>Dressing is removed on the sixth postoperative day | Procedure: augmentation mammaplasty<br>* Dressing is removed on the 6th postoperative day<br>|
| Experimental: Postoperative day 1<br>Dressing is removed on the first postoperative day | Procedure: augmentation mammaplasty<br>* Dressing is removed on the first postoperative day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin colonization | skin colonization will be measured through semi-quantitative cultures of samples collected pre-dressing and on 6th postoperative day. | 6 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical site infection | Surgical site infection will be assessed weekly, for 30 days. CDC´s criteria and definitions will be used. | 30 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast prosthesis implantation, bandages, skin colonization, surgical site infection, augmentation mammaplasty, dressing wear time