Studying How Outpatient Water affEcts Risks With Drains (SHOWER Study)
Part of paid clinical trials in Danville, Pennsylvania.
- Sponsor
- Sean Devitt
- Study ID
- NCT04725916
- Status
- Recruiting
Conditions
- Drain Site Complication
- Postoperative Complications
- Postoperative Wound Infection
- Surgical Site Infection
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Showering — OTHERPatients will be instructed to shower after surgery with drains in place
- Restriction of Showering — OTHERPatients will be restricted from showering post operatively if they have drains in place
Study Details
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.
Key Dates
- Start date
- Feb 23, 2022
- Status verified
- Feb 2026
- Primary completion
- Dec 15, 2026
- Completion
- Jul 15, 2027
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Study Arm 1Subjects assigned to Arm 1 will be instructed to shower daily beginning on post-operative Day 2 and maintain this daily schedule until the subject's 3-month standard of care clinic follow-up visit. They will receive specific instructions on caring for the incision site and drains until they are removed.
- Active Comparator: Study Arm 2Subjects assigned to Arm 2 will be instructed not to shower post-operatively until their surgical drains are removed. They will receive specific instructions on bathing and caring for the incision sites and drains.
Primary Outcome Measure
Drain site cellulitis [ Time Frame: 12 weeks ]
Central Contacts
- Sean Devitt, MD570-271-6335
- Samantha Crissinger, BS570-271-7499
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Geisinger Health | Danville | Pennsylvania | 17822 |
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