Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

Surgical site infection (SSI) after breast and axillary surgery occurs more often then 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. Bacteria present in surgical drains after tissue expander reconstruction may be decreased by simple and inexpensive local antiseptic interventions.

Further Study Information

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.

Secondary aims:

1. To determine baseline rates of bacterial colonization of drain fluid and drain tubing after tissue expander breast reconstruction.

2. To determine if bacterial colonization of fluid in the drain bulb correlates with bacterial colonization of internal segments of the drain catheter within the wound site.

3. To determine if interventions directed at drain antisepsis are associated with reduced rates of bacterial growth from tissue expander biofilm.

Methods:

Eighty-five 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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Mayo Clinic Cancer Center

Amy C Degnim, M.D.

Principal Investigator

Amy C Degnim, M.D.		Ph: 507-284-4499
		Email: degnim.amy@mayo.edu

U.S.A.
California
	San Francisco
	UCSF
		Erin Duralde	Ph: 415-353-7672
			Email: erin.duralde@ucsfmedctr.org
		Steve Miller, MD, Ph.D	Sub-Investigator
Minnesota
	Rochester
	Mayo Clinic Cancer Center
		Amy C. Degnim, M.D.	Ph: 507-538-3320
			Email: degnim.amy@mayo.edu
		Amy C. Degnim, M.D.	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01286168
Information obtained from ClinicalTrials.gov on November 20, 2012

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