Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction

This study has been completed.
Sponsor:
Collaborators:
University of California, San Francisco
Ethicon, Inc.
Information provided by (Responsible Party):
Amy C. Degnim, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01286168
First received: January 26, 2011
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

Surgical site infection (SSI) after breast and axillary surgery occurs more often than for other clean surgical procedures. Infection in the setting of a tissue expander can be devastating and can lead to early implant loss and failed reconstruction. Surgical drains have been noted as a potential source for surgical site infections. Hypothesis: Bacteria present in surgical drains after tissue expander reconstruction may be decreased by simple and inexpensive local antiseptic interventions.


Condition Intervention Phase
Nonmalignant Breast Conditions
Breast Cancer
Device: Sodium hypochlorite (Dakin's Solution)
Device: Chlorhexidine gluconate disk
Procedure: Control
Device: Occlusive Adhesive Dressing
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week [ Time Frame: Approximately 1 week after surgery ] [ Designated as safety issue: No ]
    Bacterial growth was defined as plate growth of 1+ or greater. 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.

  • Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week [ Time Frame: Approximately 1 week after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Subjects With Drain Tubing Colonization at Removal [ Time Frame: Approximately two weeks after surgery ] [ Designated as safety issue: No ]
    Drain tubing colonization was defined as greater than 50 colony forming units. Drains were removed at variable timepoints based on the clinical situation.

  • Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Removal [ Time Frame: Approximately 2 weeks after surgery ] [ Designated as safety issue: No ]
    Bacterial growth was defined as plate growth of 1+ or greater. Drains were removed a variable times across patients, per clinical indication. A second bulb culture was obtained later than 1 week ONLY in those drains that were not removed at 1 week.

  • Number of Subjects With Surgical Site Infection Within 30 Days [ Time Frame: Approximately 30 days after surgery ] [ Designated as safety issue: No ]
  • Number of Subjects With Surgical Site Infection Within 1 Year [ Time Frame: Approximately one year after surgery ] [ Designated as safety issue: No ]
  • Per Drain Analysis: Drain Tubing Colonization at Removal [ Time Frame: Approximately one month after surgery ] [ Designated as safety issue: No ]
  • Per Drain Analysis: Drain Bulb Fluid Colonization at Removal [ Time Frame: Approximately one month after surgery ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: May 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antisepsis Side
A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days. The drainage bulb will be irrigated with 10ml of 0.125% sodium hypochlorite (Dakin's solution) twice a day.
Device: Sodium hypochlorite (Dakin's Solution)
10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day
Other Names:
  • Dakin's solution
  • Wound cleanser
Device: Chlorhexidine gluconate disk
Apply one chlorhexidine disk to the intervention drain site(s) and change every three days
Other Name: BioPatch Protective Disk with CHG
Device: Occlusive Adhesive Dressing
A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days.
Other Name: Tegaderm CHG Dressing
Control Side
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 with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care.
Procedure: Control
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 with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care.

Detailed Description:

Surgical Site infection after breast surgical procedures occurs more frequently than for other clean surgical procedures. Considering the large numbers of patients who undergo breast-related procedures per year and the increasing use of immediate breast reconstruction with placement of tissue expanders or immediate implant reconstruction, a surgical site infection involving the implant can result in its removal and a failed reconstruction.

The primary aim of the study is to determine if chlorhexidine disk application and irrigation of the drainage bulb with dilute Dakin's solution (buffered sodium hypochlorite solution)after tissue expander breast reconstruction or immediate implant reconstruction, effectively decreases rates of bacterial colonization in drain fluid compared to standard care.

Methods:

Patients undergoing bilateral immediate reconstruction with tissue expander placement will have one surgical site treated with standard drain care and the other treated with a drain antisepsis regimen. Drain antisepsis intervention will consist of two measures: 1) placement of a chlorhexidine sponge dressing at the drain exit site, and 2) twice daily irrigation of the drainage bulb with dilute Dakin's solution (buffered hypochlorite).

All patients will undergo semiquantitative cultures of the drain bulb at one week postoperatively. This culture will be repeated at the time of drain removal, with simultaneous cultures of the fluid in the bulb as well as an internal segment of each removed drainage tube. All patients will be evaluated for clinical signs of infection and for any adverse reactions to the drain antisepsis at the follow-up visits.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females or males age 18-90 able to give informed consent
  • Undergoing bilateral mastectomy with immediate expander reconstruction or immediate implant reconstruction
  • May have either malignant or benign breast condition

Exclusion Criteria:

  • Antibiotic use in the fourteen days prior to surgical date
  • Undergoing unilateral tissue expander reconstruction
  • Documented allergy to chlorhexidine gluconate
  • Prior radiation therapy to the breast or chest wall (ie for breast conservation or mantle radiation for Hodgkin's disease)
  • Documented allergy to all three of the following antibiotics: cephalosporin, trimethoprim/sulfamethoxazole, and levofloxacin
  • Pregnant women
  • Vulnerable subjects - prisoners, institutionalized individuals
  • Non-English speaking patients without adequate interpreter assistance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286168

Locations
United States, California
UCSF
San Francisco, California, United States, 94107
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55904
Sponsors and Collaborators
Mayo Clinic
University of California, San Francisco
Ethicon, Inc.
Investigators
Principal Investigator: Amy C Degnim, M.D. Mayo Clinic, Rochester, MN
  More Information

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amy C. Degnim, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01286168     History of Changes
Other Study ID Numbers: 10-008061, UL1TR000135
Study First Received: January 26, 2011
Results First Received: October 13, 2014
Last Updated: October 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Bilateral breast mastectomy
Immediate tissue expanders reconstruction

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Chlorhexidine
Chlorhexidine gluconate
Eusol
Pharmaceutical Solutions
Sodium Hypochlorite
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014