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

NCT03229824 | Completed

• 1 other identifier: CEI/1090/16
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Drain antisepsis; Bacterial colonization; Surgical site infection

Outcome Measures

Primary Outcomes (2)

• Number of subjects with drain bulb fluid bacterial colonization at the first and second week postoperative.

  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.

  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 Outcomes (1)

• Number of Subjects With Surgical Site Infection Within 30 Days

  Approximately 30 days after surgery

Study Arms (2)

Antiseptic occlusive dressing group

EXPERIMENTAL

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

Standard care

NO INTERVENTION

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.

Interventions

Antiseptic occlusive dressing group DEVICE

A chlorhexidine gluconate occlusive adhesive dressing (Tegaderm CHG) will be applied to the intervention drain sites and changed every seven days.

Also known as: Tegaderm CHG Dressing

Antiseptic occlusive dressing group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institute of Cancerología: lead
• Instituto Nacional de Rehabilitacion: collaborator

Study Sites (1)

Instituto Nacional de Cancerología

Mexico City, Mexico City, 14080, Mexico

Location

Related Publications (31)

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MeSH Terms

Conditions

Breast Neoplasms; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ethics Commissioner

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: July 26, 2017
• Study Start: October 3, 2016
• Primary Completion: April 30, 2018
• Study Completion: May 30, 2018
• Last Updated: November 13, 2018

Record last verified: 2018-11

Locations

ME (1)