Studying How Outpatient Water affEcts Risks With Drains (SHOWER Study)

NCT ID: NCT04725916

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-23
• Study Completion Date: 2026-07-15

Brief 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.

Detailed Description

This is a prospective randomized, controlled, unblinded interventional feasibility trial evaluating the post-operative outcomes of surgical patients undergoing breast reduction or panniculectomy procedures. Approximately 100 eligible subjects will undergo their surgical procedure according to standard clinical guidelines. Unless clinically contraindicated, study surgeons will maintain consistent use of 10 Flat drains for all study participants to prevent any sampling bias.

Immediately after surgery is completed, the study investigator will randomize the subject into one of the 2 study arms. The randomization scheme will control for procedure type.

The study will not be blinded. The randomization assignment will be communicated to the care team and documented in the subject's electronic medical record to ensure that appropriate post-operative instruction is provided to the subject. Subjects will be notified of their study arm assignment at the time they receive their post-operative discharge instruction.

Subjects in both arms will complete a questionnaire related to quality of life post-operatively, as well as daily bathing specifics.

The following statistical methods will be used for the aims:

Aim 1: Collect and describe information related to outcome measures in addition to study data including number eligible, response rates, adherence/compliance rates.

Descriptive statistics will be provided for all study enrollment data, compliance information as well as data collected throughout the study including outcome measures and responses from the satisfaction survey.

Aim 2: To compare the surgical site complication rate of post-operative patients with drains who shower versus those who do not shower.

Complication rates between the two study arms will be compared using chi-squared tests, although these comparisons will not be conclusive since the study isn't powered to assess equivalence.

Aim 3: To compare patient post-operative satisfaction for those who shower versus those who do not shower.

Patient post-operative satisfaction between the two study arms will be compared using chi-squared tests, although these comparisons will not be conclusive since the study isn't powered to assess differences.

Conditions

Postoperative Wound Infection; Postoperative Complications; Surgical Site Infection; Drain Site Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Arm 1

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 Type: ACTIVE_COMPARATOR

Showering

Intervention Type: OTHER

Patients will be instructed to shower after surgery with drains in place

Study Arm 2

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.

Group Type: ACTIVE_COMPARATOR

Restriction of Showering

Intervention Type: OTHER

Patients will be restricted from showering post operatively if they have drains in place

Interventions

Showering

Patients will be instructed to shower after surgery with drains in place

Intervention Type: OTHER

Restriction of Showering

Patients will be restricted from showering post operatively if they have drains in place

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sean Devitt

OTHER

Sponsor Role: lead

Responsible Party

Sean Devitt

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sean Devitt, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger Health

Danville, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sean Devitt, MD

Role: CONTACT

sdevitt@geisinger.edu

570-271-6335

Samantha Crissinger, BS

Role: CONTACT

srcrissinger@geisinger.edu

570-271-7499

Facility Contacts

Sean Devitt, MD

Role: primary

sdevitt@geisinger.edu

570-271-6335

Samantha Crissinger, BS

Role: backup

srcrissinger@geisinger.edu

570-271-7499

Other Identifiers

2020-0970

Identifier Type: -

Identifier Source: org_study_id