Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05846438
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2023-04-05
Brief Title:
Effect of Drain Care on Infection Rate and Quality of Life in Implant-Based Breast Reconstruction
Sponsor:
University of Missouri-Columbia
Organization:
University of Missouri-Columbia
Study Overview
Official Title:
Effect of Drain Care on Infection Rate and Quality of Life in Implant-Based Breast Reconstruction
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn whether showering with surgical drain tubes in place after first stage breast reconstruction causes increased risk of infection The main questions it aims to answer are
Is there an increased risk of infectioncomplications with showering 48 hours after drain tubes are in place
Does showering after 48 hours with drain tubes in place affect quality of life
Is there an increased risk of infectioncomplications with showering 48 hours after drain tubes are in place
Does showering after 48 hours with drain tubes in place affect quality of life
Detailed Description:
SSI soft tissue infection is an aggravating risk specifically associated with implants Breast reconstruction quotes infection rates anywhere from 1-35 while cosmetic augmentations quote rates around 15 Usually the causative organisms are skin flora like Staph aureus and Staph epidermidis Occasionally mycobacterium and other atypical bacterium are isolated more commonly in the immunocompromised Despite perioperative antibiotics SSI is still a prevalent complication increasing total expenditure of patients and hospital systems upwards of 4000patient in reoperation fees and hospital stay costs Skin prep and antibiotics in the preoperative phase is very important to the sterile technique and decreasing risk of infection by decreasing bacterial load at the time of incision and surgery However postoperative care and interventions are less strictly evaluated and defined Currently there is no standard of care in regards to showering post operatively with JP Jackson-Pratt drains in place Timing of showering is ultimately based on surgeon preference In practice the investigators routinely have had patients wait to shower until the JP drains are removed The investigators hypothesize that showering daily even with drains in place will not increase rates of infection in breast reconstruction and perhaps improve quality of life during first stage This study is prospective with participants randomized to either shower daily after 48hrs or standard of care and shower after drains removed The participants will be asked to fill out a quality of life survey 90 days after enrollment The patients will also be monitored for signs of infection for 90 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None