Breast Cancer Clinical Trial
Official title:
Randomized Controlled Trial to Reduce Surgical Site Infections in Breast Cancer Surgery With Clorhexidine Gluconate Securement Dressing (Tegaderm CHG)
Surgical site infection (SSI) after breast and axillary surgery occurs more often than for other clean surgical procedures. Infection in the setting of sick woman could delay the adjuvant therapy and result increase morbidity and mortality. Also this increased costs associated with health care.Surgical drains have been noted as a potential source for surgical site infections. The primary aim of the study is to determine if chlorhexidine occlusive dressings applied to the intervention drain sites effectively decreases rates of bacterial colonization in drain fluid and drain tips compared to standard care.
Following approval by the National Cancer Institute Review Board, eligible subjects will be
recruited prospectively from the Breast Cancer Department at National Cancer Institute,
México from November 2016 to November 2017. Individuals with confirmed cancer undergoing
total mastectomy (TM), modified radical mastectomy (MRM) and/or axillary lymph node
dissection (ALND) in which surgical drains are going to be used will be identified through
the surgical scheduling sheet. If the subjects are eligible according to the inclusion
criteria, the will be interviewed by one of the main researchers. In the initial interview
the informed consent will be read and signed. Also the study coordinator will collect the
data of interest from the medical records and will register it in a data collection sheet
specially created for this project.
Following informed consent, participants will be randomize to either the standard drain care
regimen or the drain antisepsis regimen by a computerized randomization program, using
dynamic allocation and stratifying by surgical procedure (radical surgery or conservative
surgery). Subjects who had bilateral cancer underwent to the same regimen for both sides. The
operating surgeon will know the assigned treatment arm at the end of the surgery.
The surgery will consist on placing a chlorhexidine gluconate occlusive adhesive dressing to
the drains side at the end of the surgery. The dressing will be changed each 7 (+-1) days
until the drain is removed.
All the participants and the principal take-carers, despite of the group of participation,
will be personal instructed by a member of the research team in the first hours of the
postoperative, before the departure. In addition, they will be given paper based instructions
for the general care of the drain and the surgery wound.
For the experimental group, the dressing will be changed each 7(+-1) days; The site of the
insertion must be cleaned with 70% concentration isopropyl alcohol towels. The evaluation and
quantification of the drained fluid will be done every 12 hours as it is done usually in
these patients.
The patients will be followed for 30 days from the surgery until the resolution of the
infectious complication, if it occurs. The patients will go at the end of the first
postoperative week (POP 7+-1). In each visit, the coordinator of the study will register the
information of the patient in the register sheet. In each visit the patient will be
evaluated, the characteristics of the surgical wound and the characteristics of drain fluid
will be consigned in the protocol register sheet. The investigator will verify that the
participants have correctly done the clean-up the drain.
All patients will undergo semiquantitative cultures of the drain bulb at the first and second
week postoperative. Also the investigators will take the distal part of the internal segment
of each removed drainage tube for semiquantitative culture. All participants will be
evaluated for clinical signs of infection and for any adverse reactions to the drain
antisepsis at the follow-up visits. In case of a surgical site infection, the patient will
receive the right treatment and will remain in surveillance until the resolution.
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