Surgical Site Infection
Conditions
Keywords
breast, plastic surgery, bandages, surgical site infection, skin colonization
Brief summary
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
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.
Interventions
OTHERIncisions covered for 1 day
Dressing was removed on the first postoperative day.
OTHERIncisions covered for 6 days
Dressing was removed on the 6th postoperative day.
Sponsors
Universidade do Vale do Sapucai
Daniela Francescato Veiga
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infection (SSI) | 30th postoperative day and one year after operation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin colonization | 6 days postoperatively | Samples are collected to cultures before dressing (control) and at the 6th postoperative day |
| Patients self assessments | 2 weeks postoperatively | Patients scored dressing wear time with regard to safety, comfort and convenience. |
Countries
Brazil
Outcome results
None listed