NCT01176786

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

November 7, 2017

Status Verified

June 1, 2017

Enrollment Period

2.4 years

First QC Date

August 5, 2010

Last Update Submit

November 3, 2017

Conditions

MastectomyInfectionsBreast Reconstruction

Keywords

infectiontissue expanderbreast implantbreast reconstructionInfections rates

Outcome Measures

Primary Outcomes (1)

  • Infection rates of reusable versus disposable draping system in the operating room

    5 years

Interventions

Culture Swabs, Rodac Plate CulturesOTHER

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Baptist Medical Center Plastic & Reconstructive Surgery Department

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Lisa David

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2010

First Posted

August 6, 2010

Study Start

September 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

November 7, 2017

Record last verified: 2017-06

Locations

US(1)