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Reusable Versus Disposable Draping System in Breast Reconstruction Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01176786
First Posted: August 6, 2010
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lisa David, Wake Forest University Health Sciences
  Purpose
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.

Condition Intervention
Mastectomy Infections Breast Reconstruction Other: Culture Swabs, Rodac Plate Cultures

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Lisa David, Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Infection rates of reusable versus disposable draping system in the operating room [ Time Frame: 5 years ]

Enrollment: 107
Study Start Date: September 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Culture Swabs, Rodac Plate Cultures
    Culture swab is taken when breast tissue expander is removed and when breast implant is placed in breast pocket. Rodac Plate cultures are taken after the surgical procedure of the surgeons dominant palm, forearm of gown and subject's drape closest to the breast.
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 the disposable draping system. Subjects will be blinded to the type of draping system used. Subjects are under anesthesia at the time the surgical drapes are placed. After the subject has signed the informed consent, they will be assigned a study number for that surgery. The study number will correlate to an envelope which will contain information on the type of draping system to be used. Subjects enrolled, may be randomized more than once. Subjects will typically have a minimum of two surgeries, the placement of the tissue expanders and then the removal of the expanders and placement of the breast implants. Subjects will not be required to sign another consent form but will be randomized prior to each surgery. Surgeons who have subjects in the disposable draping system will use a disposable draping kit that includes gowns for the surgeons and also towels. For subjects who are having a mastectomy and then the placement of tissue expanders, after the mastectomy has been performed, the plastic surgeons will use all new draping, towels and gowns to perform tissue expander placement. A swab will be taken on the wound site to determine if there are any CFUs (colony forming units) present. The swab will then be placed in a tube containing 1ml of TSB (triptic soy broth). The tube will then be sonicated , and then vortexed for 15 seconds. A 0.1ml aliquot of the solution will be placed in a blood agar plate and incubated for 48 hours to determine the CFU count. The remainder of the solution will be frozen. In the event an infection occurs, molecular matching will be done on the culture to determine if it is from the same exact culture. Rodac plates will be used to test for the presence of bacterial cultures on the surgeon's gown (Forearm [volar surface]) and glove (palm of surgeon's dominate hand) and also the subject's surgical drape (Area over sternum). These will be incubated for 48 hours to determine the CFU count. This process will be repeated at the second surgery.
  Eligibility

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

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.

  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, North Carolina
Wake Forest University Baptist Medical Center Plastic & Reconstructive Surgery Department
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
  More Information

Responsible Party: Lisa David, Professor, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01176786     History of Changes
Other Study ID Numbers: 10667
First Submitted: August 5, 2010
First Posted: August 6, 2010
Last Update Posted: June 5, 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 Lisa David, Wake Forest University Health Sciences:
infection
tissue expander
breast implant
breast reconstruction
Infections rates

Additional relevant MeSH terms:
Infection
Communicable Diseases