Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Nonmalignant Breast Conditions
• Intervention / Treatment: Device: Sodium hypochlorite (Dakin's Solution); Device: Chlorhexidine gluconate disk; Device: Occlusive Adhesive Dressing; Procedure: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94107
      • UCSF
  • Minnesota
    • Rochester, Minnesota, United States, 55904
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Wound cleanser; Dakin's solution; Device: Chlorhexidine gluconate disk; Apply one chlorhexidine disk to the intervention drain site(s) and change every three days; Other Names: 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 Names: Tegaderm CHG Dressing
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week	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.	Approximately 1 week after surgery
Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week		Approximately 1 week after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Drain Tubing Colonization at Removal	Drain tubing colonization was defined as greater than 50 colony forming units. Drains were removed at variable timepoints based on the clinical situation.	Approximately two weeks after surgery
Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Removal	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.	Approximately 2 weeks after surgery
Number of Subjects With Surgical Site Infection Within 30 Days		Approximately 30 days after surgery
Number of Subjects With Surgical Site Infection Within 1 Year		Approximately one year after surgery
Per Drain Analysis: Drain Tubing Colonization at Removal		Approximately one month after surgery
Per Drain Analysis: Drain Bulb Fluid Colonization at Removal		Approximately one month after surgery

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: University of California, San Francisco; Ethicon, Inc.
• Investigators: Principal Investigator: Amy C Degnim, M.D., Mayo Clinic, Rochester, MN

Publications and helpful links

General Publications

• Degnim AC, Scow JS, Hoskin TL, Miller JP, Loprinzi M, Boughey JC, Jakub JW, Throckmorton A, Patel R, Baddour LM. Randomized controlled trial to reduce bacterial colonization of surgical drains after breast and axillary operations. Ann Surg. 2013 Aug;258(2):240-7. doi: 10.1097/SLA.0b013e31828c0b85.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: January 26, 2011
• First Submitted That Met QC Criteria: January 27, 2011
• First Posted (Estimate): January 31, 2011

Study Record Updates

• Last Update Posted (Estimate): December 19, 2014
• Last Update Submitted That Met QC Criteria: December 3, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Bilateral breast mastectomy; Immediate tissue expanders reconstruction
• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Pharmaceutical Solutions; Chlorhexidine; Chlorhexidine gluconate; Sodium Hypochlorite; Eusol
• Other Study ID Numbers: 10-008061; UL1TR000135 (U.S. NIH Grant/Contract)