Time of Permanence of Dressing Following Breast Reconstruction
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|ClinicalTrials.gov Identifier: NCT01148823|
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : February 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Surgical Site Infection||Other: Incisions covered for 1 day Other: Incisions covered for 6 days||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Influence of Time of Permanence of Dressing Following Breast Reconstruction on Skin Colonization and on Surgical Site Infection Rates|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Experimental: Postoperative day 1
Dressing was removed on the first postoperative day
Other: Incisions covered for 1 day
Dressing was removed on the first postoperative day.
Other Name: PO1
Experimental: Postoperative day 6
Dressing was removed on the 6th postoperative day
Other: Incisions covered for 6 days
Dressing was removed on the 6th postoperative day.
Other Name: PO6
- Surgical site infection (SSI) [ Time Frame: 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.
- Skin colonization [ Time Frame: 6 days postoperatively ]Samples are collected to cultures before dressing (control) and at the 6th postoperative day
- Patients self assessments [ Time Frame: 2 weeks postoperatively ]Patients scored dressing wear time with regard to safety, comfort and convenience.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148823
|Hospital das Clinicas Samuel Libânio, Universidade do Vale do Sapucaí|
|Pouso Alegre, MG, Brazil, 37550000|
|Study Chair:||Daniela F Veiga, MD, PhD||Universidade do Vale do Sapucaí and Universidade Federal de São Paulo|