Reusable Versus Disposable Draping System in Breast Reconstruction Surgery
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ClinicalTrials.gov Identifier: NCT01176786 |
Recruitment Status
:
Completed
First Posted
: August 6, 2010
Last Update Posted
: November 7, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mastectomy Infections Breast Reconstruction | Other: Culture Swabs, Rodac Plate Cultures | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 107 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Basic Science |
Official Title: | The Effect of Reusable Versus Disposable Draping on Implant Based Breast Reconstruction Infection Rates: a Prospective Randomized Study |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | February 2012 |
Actual Study Completion Date : | February 2012 |
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Other: Culture Swabs, Rodac Plate Cultures
- Infection rates of reusable versus disposable draping system in the operating room [ Time Frame: 5 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 Criteria:
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01176786
United States, North Carolina | |
Wake Forest University Baptist Medical Center Plastic & Reconstructive Surgery Department | |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | Lisa David | Wake Forest University Health Sciences |
Responsible Party: | Wake Forest University Health Sciences |
ClinicalTrials.gov Identifier: | NCT01176786 History of Changes |
Other Study ID Numbers: |
10667 |
First Posted: | August 6, 2010 Key Record Dates |
Last Update Posted: | November 7, 2017 |
Last Verified: | June 2017 |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Wake Forest University Health Sciences:
infection tissue expander breast implant breast reconstruction Infections rates |
Additional relevant MeSH terms:
Infection Communicable Diseases |