Use of Clorhexidine Dressings to Reduce Surgical Site Infections in Breast Cancer Surgery. A Controlled Clinical Trial

November 9, 2018 updated by: MYRNA CANDELARIA, MD PHD, National Institute of Cancerología

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • DF
      • Mexico City, DF, Mexico, 14080
        • Instituto Nacional De Cancerologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females minimum age 18 able to give informed consent
  • Breast cancer confirmed by histopathology
  • Patients undergoing unilateral or bilateral mastectomy with or without immediate expander reconstruction.

Exclusion Criteria:

  • Males
  • Patients who deny informed consent
  • Prior radiation therapy to the sick breast.
  • Pregnant or breastfeeding women
  • Patients undergoing immediate breast reconstruction with Deep Inferior
  • Epigastric Perforator (DIEP) o Transverse Rectus Abdominal Muscle techniques (TRAM) .
  • Emergency procedures
  • Documented allergy to chlorhexidine gluconate
  • Antibiotic use in the fourteen days prior to surgical date
  • Patients with a history or suspicion of breast cancer surgery outside the INCan in the previous three months.
  • Patients who do not speak spanish, diagnosed with a psychiatric disorder and in whom a minimum follow-up of 14 days couldn't be feasible because of operative difficulties (eg.

place of residence or reference to other health institutions).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Antiseptic occlusive dressing group
A chlorhexidine gluconate occlusive adhesive dressing (Tegaderm CHG) will be applied to the intervention drain sites and changed every seven days.
Device: Antiseptic occlusive dressing group
A chlorhexidine gluconate occlusive adhesive dressing (Tegaderm CHG) will be applied to the intervention drain sites and changed every seven days.
Other Names:
  • Tegaderm CHG Dressing
No Intervention: Standard care
Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site and the tubing with a cotton swab dipped in rubbing alcohol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with drain bulb fluid bacterial colonization at the first and second week postoperative.
Time Frame: Approximately 1 or 2 weeks after surgery
Bacterial growth was defined as plate growth >10*5 colony forming unit (CFU). Drains were removed at variable times across patients, per clinical indication. When clinically indicated, some patients did have their drains removed at the one week visit, in which case they only had one bulb fluid culture.
Approximately 1 or 2 weeks after surgery
Number of subjects with drain tip bacterial colonization at removal.
Time Frame: Approximately at the second and/or third week after surgery
Bacterial growth was defined as plate growth >15 CFU by semiquantitative technique or >10*5 CFU by sonication and fluid culture. Drains were removed at variable times across patients, per clinical indication.
Approximately at the second and/or third week after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Surgical Site Infection Within 30 Days
Time Frame: Approximately 30 days after surgery
Surgical site infection was diagnosed according the definitions given by the Centers for Disease Control and Prevention (CDC).
Approximately 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Cancerología

Collaborators

Instituto Nacional de Rehabilitacion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2016

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

May 30, 2018

Study Registration Dates

First Submitted

April 21, 2017

First Submitted That Met QC Criteria

July 24, 2017

First Posted (Actual)

July 26, 2017

Study Record Updates

Last Update Posted (Actual)

November 13, 2018

Last Update Submitted That Met QC Criteria

November 9, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI/1090/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Results at the end of study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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