Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
NCT ID: NCT01286168
Last Updated: 2014-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2011-05-31
2013-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
SINGLE
Study Groups
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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.
Sodium hypochlorite (Dakin's Solution)
10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day
Chlorhexidine gluconate disk
Apply one chlorhexidine disk to the intervention drain site(s) and change every three days
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.
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.
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.
Interventions
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Sodium hypochlorite (Dakin's Solution)
10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day
Chlorhexidine gluconate disk
Apply one chlorhexidine disk to the intervention drain site(s) and change every three days
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing bilateral mastectomy with immediate expander reconstruction or immediate implant reconstruction
* May have either malignant or benign breast condition
Exclusion Criteria
* 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
18 Years
90 Years
ALL
Yes
Sponsors
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University of California, San Francisco
OTHER
Ethicon, Inc.
INDUSTRY
Mayo Clinic
OTHER
Responsible Party
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Amy C. Degnim
MD
Principal Investigators
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Amy C Degnim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic, Rochester, MN
Locations
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UCSF
San Francisco, California, United States
Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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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.
Other Identifiers
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10-008061
Identifier Type: -
Identifier Source: org_study_id