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| Name | Class |
|---|---|
| Universidade do Vale do Sapucai | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postoperative day 1 | Experimental | Dressing was removed on the first postoperative day |
|
| Postoperative day 6 | Experimental | Dressing was removed on the 6th postoperative day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incisions covered for 1 day | Other | Dressing was removed on the first postoperative day. |
|
| 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 |
| 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. |
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Inclusion Criteria:
•candidate to immediate or delayed breast reconstruction after mastectomy or segmental mastectomy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniela F Veiga, MD, PhD | Universidade do Vale do Sapucaà and Universidade Federal de São Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clinicas Samuel Libânio, Universidade do Vale do Sapucaà | Pouso Alegre | Minas Gerais | 37550000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23432779 | Background | Veiga DF, Veiga-Filho J, Damasceno CA, Sales EM, Morais TB, Almeida WE, Novo NF, Ferreira LM. Dressing wear time after breast reconstruction: study protocol for a randomized controlled trial. Trials. 2013 Feb 22;14:58. doi: 10.1186/1745-6215-14-58. | |
| Result | Veiga DF, Veiga-Filho J, Mendes DA, Sales AM, Damasceno Ca, Ferreira LM. Dressing wear time after breast reconstruction: preliminary results of a randomized controlled trial. Plastic and Reconstructive Surgery 131(5S): 119, 2013. | ||
| 27911904 |
| Label | URL |
|---|---|
| Study Protocol | View source |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| Incisions covered for 6 days | Other | Dressing was removed on the 6th postoperative day. |
|
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| 2 weeks postoperatively |
| Result |
| Veiga DF, Damasceno CA, Veiga-Filho J, Paiva LF, Fonseca FE, Cabral IV, Pinto NL, Juliano Y, Ferreira LM. Dressing Wear Time after Breast Reconstruction: A Randomized Clinical Trial. PLoS One. 2016 Dec 2;11(12):e0166356. doi: 10.1371/journal.pone.0166356. eCollection 2016. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |