Reusable Versus Disposable Draping System in Breast Reconstruction Surgery

The Effect of Reusable Versus Disposable Draping on Implant Based Breast Reconstruction Infection Rates: a Prospective Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Infections; Breast Reconstruction; Mastectomy
• Intervention / Treatment: Other: Culture Swabs, Rodac Plate Cultures

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.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Baptist Medical Center Plastic & Reconstructive Surgery Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Infection rates of reusable versus disposable draping system in the operating room	5 years

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Lisa David, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): February 1, 2012
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: August 5, 2010
• First Submitted That Met QC Criteria: August 5, 2010
• First Posted (ESTIMATE): August 6, 2010

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 3, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: infection; breast reconstruction; tissue expander; breast implant; Infections rates
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 10667 (Other Identifier: CTEP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No