Time of Permanence of Dressing Following Breast Reconstruction

Study Overview
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Brief Summary
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This randomized clinical trial was designed to assess the influence of time of dressing after breast reconstruction procedures on surgical site infections rates and skin colonization.

Detailed Description
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The rates of surgical site infections (SSI) after clean operations range from 1 to 2%. However, infection rates in the breast surgical literature tend to be higher, with reported rates ranging from 2 to 30%. In plastic surgery operations, to minimize the risk of SSI is imperative, since even minor infections are able to complicate the healing process and harm the cosmetic result. The Centers for Disease Control and Prevention has established guidelines for postoperative incision care. However, there is no recommendation to cover an incision closed primarily beyond 48 hours, nor on the appropriate time to shower or bathe with an uncovered incision. This remains an unresolved issue.

Official Title
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Influence of Time of Permanence of Dressing Following Breast Reconstruction on Skin Colonization and on Surgical Site Infection Rates

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Other: Incisions covered for 1 day
* Other: Incisions covered for 6 days


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: •candidate to immediate or delayed breast reconstruction after mastectomy or segmental mastectomy Exclusion Criteria: use of antibiotics at the time of the operation presence of skin lesions on the surgical site body mass index over 35Kg/m2 hard smoking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postoperative day 1<br>Dressing was removed on the first postoperative day | Other: Incisions covered for 1 day<br>* Dressing was removed on the first postoperative day.<br>* Other names: PO1;|
| Experimental: Postoperative day 6<br>Dressing was removed on the 6th postoperative day | Other: Incisions covered for 6 days<br>* Dressing was removed on the 6th postoperative day.<br>* Other names: PO6;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection (SSI) | Patients are followed weekly by a masked surgeon in regard to SSI, until the 30th postoperative day.CDC's criteria and classification was adopted.Patients are reevaluated at the end of the first year after operation. | 30th postoperative day and one year after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin colonization | Samples are collected to cultures before dressing (control) and at the 6th postoperative day | 6 days postoperatively | 
| Patients self assessments | Patients scored dressing wear time with regard to safety, comfort and convenience. | 2 weeks postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast, plastic surgery, bandages, surgical site infection, skin colonization