Clinical trial NCT01148823: Time of Permanence of Dressing Following Breast Reconstruction
Official title: Influence of Time of Permanence of Dressing Following Breast Reconstruction on Skin Colonization and on Surgical Site Infection Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Keywords: breast
plastic surgery
bandages
surgical site infection
skin colonization
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Universidade do Vale do Sapucai
First posted: 2010-06-22
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Surgical site infection (SSI)
timeFrame: 30th postoperative day and one year after operation
Secondary outcomes:
measure: Skin colonization
timeFrame: 6 days postoperatively
measure: Patients self assessments
timeFrame: 2 weeks postoperatively
Other outcomes:
Locations:
city: Pouso Alegre
country: Brazil
facility: Hospital das Clinicas Samuel Libânio, Universidade do Vale do Sapucaí
state: MG
Study officials:
affiliation: Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
name: Daniela F Veiga, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.