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Showering With Drains for Surgical Site Infection Risk (SHOWER Trial)

N/A
Recruiting
Led By Sean Devitt, MD
Research Sponsored by Sean Devitt
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients having one of the following procedures at Geisinger Medical Center in which drains are placed
≥18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

SHOWER Trial Summary

This trial will study whether it is safe for patients to shower with their post-operative drains still in place.

Who is the study for?
This trial is for adults over 18 who are having breast reductions or panniculectomies at Geisinger Medical Center and will have drains placed post-surgery. They must be able to consent. It's not for those on antibiotics, healthcare workers with patient contact, patients staying in the hospital >1 night, or needing a panniculectomy before kidney transplant.Check my eligibility
What is being tested?
The SHOWER Study is testing whether showering with surgical drains after breast reductions or panniculectomies affects infection rates. Participants are randomly assigned to either shower with the drains in place or avoid showering until the drains are removed.See study design
What are the potential side effects?
Since this study involves standard postoperative care procedures (showering vs. not), side effects aren't drug-related but may include an increased risk of infections and complications at the drain site if any adverse effects from water exposure occur.

SHOWER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having a procedure at Geisinger Medical Center that requires drains.
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I am 18 years old or older.
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I have had a breast reduction.
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I have had a specific type of tummy tuck surgery.
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I am scheduled for or have had a lower panniculectomy.

SHOWER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Abscess formation
Drain site cellulitis
Incisional cellulitis
+3 more

SHOWER Trial Design

2Treatment groups
Active Control
Group I: Study Arm 1Active Control1 Intervention
Subjects 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.
Group II: Study Arm 2Active Control1 Intervention
Subjects 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.

Find a Location

Who is running the clinical trial?

Sean DevittLead Sponsor
Sean Devitt, MDPrincipal InvestigatorGeisinger Clinic

Media Library

Study Arm 1 Clinical Trial Eligibility Overview. Trial Name: NCT04725916 — N/A
Drain Site Complication Research Study Groups: Study Arm 1, Study Arm 2
Drain Site Complication Clinical Trial 2023: Study Arm 1 Highlights & Side Effects. Trial Name: NCT04725916 — N/A
Study Arm 1 2023 Treatment Timeline for Medical Study. Trial Name: NCT04725916 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an open call for participants to enroll in this trial?

"Affirmative, the clinical trial is open to enrollment and is visible on clinicaltrials.gov. It was first posted on February 23rd 2022 and last modified on August 2nd 2022. The study aims to enroll 100 subjects at one location."

Answered by AI

What is the cap on recruitment for this clinical trial?

"Indeed, clinicaltrials.gov confirms that this test is currently enrolling patients. This study was initially advertised on February 23rd 2022 and has since been updated on August 2nd 2022. The researchers are seeking 100 participants from a single site to partake in the trial."

Answered by AI
~7 spots leftby Jun 2024