What this study is
This is a prospective randomized, controlled, unblinded, interventional feasibility study to evaluate if showering with post operative drains in place leads to an increase in complications. The patients included in the study will be those undergoing breast reductions and panniculectomies at Geisinger Medical Center. The patients will be randomized post operatively into one of two groups: 1) patients instructed to shower with drains in place, and 2) patients instructed not to shower while they have drains in place.
What's being tested
- Showering
Intervention · OTHER
Patients will be instructed to shower after surgery with drains in place
- Restriction of Showering
Intervention · OTHER
Patients will be restricted from showering post operatively if they have drains in place
Study details
- Sponsor
- Sean Devitt
- Conditions
- Postoperative Wound Infection · Postoperative Complications · Surgical Site Infection · Drain Site Complication
- Enrolling
- 100 people
- Starts
- 2022-02-23
- Est. completion
- 2026-07-15
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Patients having one of the following procedures at Geisinger Medical Center in which drains are placed; Breast reduction; Lower panniculectomy; Fleur-de-lis panniculectomy
- ≥18 years of age
- Able and willing to provide consent
You can't join if
- Patients on antibiotics at the time of surgery
- Patients sent home on antibiotics after surgery
- Patients who work in healthcare with direct patient contact
- Patients having a panniculectomy to be eligible for a kidney transplant
- Patients having a ventral hernia repair at the time of the panniculectomy
- Patients admitted to the hospital for >1 night
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openGeisinger Health
Danville, Pennsylvania, United States
- Sean Devitt, MD · Contact570-271-6335sdevitt@geisinger.edu
- Samantha Crissinger, BS · Contact570-271-7499srcrissinger@geisinger.edu
Recruiting
Study team
Sponsor
Sean Devitt
Study ID 2020-0970
Principal investigator
Sean Devitt, MD
Geisinger Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.