Reusable Versus Disposable Draping System in Breast Reconstruction Surgery

NCT ID: NCT01176786

Last Updated: 2017-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-02-29

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 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.

Conditions

Mastectomy; Infections; Breast Reconstruction

Keywords

infection; tissue expander; breast implant; breast reconstruction; Infections rates

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa David

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Baptist Medical Center Plastic & Reconstructive Surgery Department

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

10667

Identifier Type: -

Identifier Source: org_study_id