NCT04725916 · Sean Devitt
Studying How Outpatient Water affEcts Risks With Drains (SHOWER Study)
(SHOWER)
What this study is about
This is a forward-looking randomly assigned, 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.
View original scientific description
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.
Interventions
OTHER
Showering
Patients will be instructed to shower after surgery with drains in place
OTHER
Restriction of Showering
Patients will be restricted from showering post operatively if they have drains in place
Primary outcome measures
Drain site cellulitis
Time frame: 12 weeks
At each post operative appointment, the patient's drain sites will be examined for signs of cellulitis including tenderness to palpation and blanching erythema. The decision will be based on clinical exam by the physicians assistant, confirmed with the attending physician, and photos will be taken for documentation.
Incisional cellulitis
Time frame: 12 weeks
At each post operative appointment, the patient's incision will be examined for signs of cellulitis including tenderness to palpation and blanching erythema. The decision will be based on clinical exam by the physicians assistant, confirmed with the attending physician, and photos will be taken for documentation.
Seroma formation
Time frame: 12 weeks
At each post operative visit, the patient will be examined to rule out the presence of wound seroma. Any seroma requiring needle aspiration with removal of fluid will be documented as a positive seroma.
Abscess formation
Time frame: 12 weeks
The patient will be examined at each post operative visit. Any collection of bacteria (abscess) that requires bedside drainage will be recorded as an abscess.
Wound dehiscence
Time frame: 12 weeks
Development of wound dehiscence during follow-up period
Patient Satisfaction
Time frame: 12 weeks
Measurement of patient satisfaction of post-operative ability to shower based on administration of a satisfaction survey
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Danville, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 20, 2026 · Source of record for eligibility and locations