Clinical trial NCT01286168: Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
Official title: Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonmalignant Breast Conditions
Breast Cancer
Keywords: Bilateral breast mastectomy
Immediate tissue expanders reconstruction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Ethicon, Inc.
First posted: 2011-01-31
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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 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.

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 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

Primary outcomes:
measure: Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week
timeFrame: Approximately 1 week after surgery
measure: Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week
timeFrame: Approximately 1 week after surgery
Secondary outcomes:
measure: Number of Subjects With Drain Tubing Colonization at Removal
timeFrame: Approximately two weeks after surgery
measure: Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Removal
timeFrame: Approximately 2 weeks after surgery
measure: Number of Subjects With Surgical Site Infection Within 30 Days
timeFrame: Approximately 30 days after surgery
measure: Number of Subjects With Surgical Site Infection Within 1 Year
timeFrame: Approximately one year after surgery
measure: Per Drain Analysis: Drain Tubing Colonization at Removal
timeFrame: Approximately one month after surgery
measure: Per Drain Analysis: Drain Bulb Fluid Colonization at Removal
timeFrame: Approximately one month after surgery
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic, Rochester, MN
name: Amy C Degnim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.