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

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ClinicalTrials.gov Identifier: NCT03229824
Recruitment Status : Recruiting
First Posted : July 26, 2017
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Instituto Nacional de Rehabilitacion
Information provided by (Responsible Party):
MYRNA CANDELARIA, MD PHD, National Institute of Cancerología

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Antiseptic occlusive dressing group Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial to Reduce Surgical Site Infections in Breast Cancer Surgery With Clorhexidine Gluconate Securement Dressing (Tegaderm CHG)
Actual Study Start Date : October 3, 2016
Estimated Primary Completion Date : May 30, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

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 Name: 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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).


Information from the National Library of Medicine

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): NCT03229824


Contacts
Contact: Diana Vilar-Compte, MD, MSc +52 555 628 0400 ext 12110 diana_vilar@yahoo.com.mx
Contact: Frida Rivera Buendía, MD +52 555 628 0400 ext 12110 frida.rivera06@gmail.com

Locations
Mexico
Instituto Nacional de Cancerología Recruiting
Mexico City, DF, Mexico, 14080
Contact: Diana Vilar-Compte, MD, MsC    +52 555 628 0400 ext 12110    diana_vilar@yahoo.com.mx   
Contact: Frida Rivera Buendía, MD    +52 555 628 0400 ext 12110    frida.rivera06@gmail.com   
Principal Investigator: Diana Vilar-Compte         
Sub-Investigator: Frida Rivera Buendía         
Sponsors and Collaborators
National Institute of Cancerología
Instituto Nacional de Rehabilitacion

Publications:
Instituto Nacional de Geografía y estadística. "Estadísticas a propósito del día mundial de la lucha contra el cáncer de mama (19 de octubre)". Recuperado el 15 de febrero del 2016, de www.inegi.org.mx/aproposito/mama0
Arce et al. Oncoguía: Cáncer de Mama. Cancerología 6, 2001; p77-86.
XXXIII Congreso Nacional de la Asociación Mexicana de Infectología y Microbiología Clínica, A.C. León, Guanajuato; 14-17 de mayo de 2008.
Penel N, Yazdanpanah Y, Chauvet MP, Clisant S, Giard S, Neu JC, Lefebvre D, Fournier C, Bonneterre J. Prevention of surgical site infection after breast cancer surgery by targeted prophylaxis antibiotic in patients at high risk of surgical site infection. J Surg Oncol. 2007 Aug 1;96(2):124-9. Erratum in: J Surg Oncol. 2008 Apr 1;97(5):479. Nicolas, Penel [corrected to Penel, Nicolas]; Yazdan, Yazdanpanah [corrected to Yazdanpanah, Yazdan]; Marie-Pierre, Chauvet [corrected to Chauvet, Marie-Pierre]; Stéphanie Clisant [corrected to Clisant, Stéphanie]; Sylvia, Giard [corrected to Giard, Sylvia]; Jean-Charles, Neu [corrected to Neu, Jean-Charles]; Danièle, Lefebvre [corrected to Lefebvre, Danièle]; Charles, Fournier [corrected to Fournier, Charles] Jacques, Bonneterre [corrected to Bonneterre, Jacques].

Responsible Party: MYRNA CANDELARIA, MD PHD, Ethics Commissioner, National Institute of Cancerología
ClinicalTrials.gov Identifier: NCT03229824     History of Changes
Other Study ID Numbers: CEI/1090/16
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Results at the end of study

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by MYRNA CANDELARIA, MD PHD, National Institute of Cancerología:
Drain antisepsis
Bacterial colonization
Surgical site infection

Additional relevant MeSH terms:
Breast Neoplasms
Infection
Surgical Wound Infection
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Wound Infection
Postoperative Complications
Pathologic Processes
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents