Status:
COMPLETED
Reusable Versus Disposable Draping System in Breast Reconstruction Surgery
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Mastectomy
Infections
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study will look at the rate of infections developed by subjects comparing the use of disposable draping systems versus reusable draping systems in the operating room.
Detailed Description
Subjects enrolled in the study will be randomized into two groups. One group will have the reusable draping system during surgery which the investigators currently use and the second group will have t...
Eligibility Criteria
Inclusion
- Females ages 18 years of age and older who are having a mastectomy with tissue expander placement and for breast implants for reconstruction, which would include immediate or delayed reconstruction.
Exclusion
- Male subjects are excluded from this study, while some males do have breast cancer, this is a rare occurrence and they do not undergo reconstruction surgery with expanders and breast implants. Females under the age of 18 are excluded as well as females who undergo a mastectomy but do not have any reconstruction surgery. Females who otherwise meet the criteria but have an active infection, currently on antibiotics to treat an infection, urinary tract infections, soft tissue infections or pneumonia are also excluded until they are approved for surgery by the physician.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT01176786
Start Date
September 1 2009
End Date
February 1 2012
Last Update
November 7 2017
Active Locations (1)
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1
Wake Forest University Baptist Medical Center Plastic & Reconstructive Surgery Department
Winston-Salem, North Carolina, United States, 27157