Studying How Outpatient Water affEcts Risks With Drains (SHOWER Study) (NCT04725916) | Clinical Trial Compass
RecruitingNot Applicable
Studying How Outpatient Water affEcts Risks With Drains (SHOWER Study)
United States100 participantsStarted 2022-02-23
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This SHOWER study seems to be testing whether it's safe to get my surgical drain site wet while showering at home — is that something you'd normally advise against after my specific surgery, and would being in this trial change what I'm currently allowed to do?
2Since this trial is measuring things like drain site cellulitis, abscess formation, and wound dehiscence, what would the warning signs of those complications look like for me, and how quickly would I need to contact you if I noticed them?
3This study is listed as 'Phase NA,' which usually means it's more about comparing care practices than testing a new drug or device — does that mean the risks of participating are similar to what I'd face with standard post-surgical wound care instructions?
4Given that patient satisfaction is one of the things being measured alongside infection outcomes, what does participation actually require of me day-to-day at home, and is that realistic given my recovery situation?
5If I choose not to join this trial, what are your current recommendations about showering and protecting my drain site, and would I be missing out on any benefit that the trial might offer?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.