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

NCT04725916 | Recruiting

• 1 other identifier: 2020-0970
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Panniculectomy; Breast reduction surgery; Postoperative showering; Surgical drain; Fleur-de-lis panniculectomy; Massive weight loss surgery

Outcome Measures

Primary Outcomes (6)

• Drain site cellulitis

  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.

  12 weeks

• Incisional cellulitis

  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.

  12 weeks

• Seroma formation

  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.

  12 weeks

• Abscess formation

  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.

  12 weeks

• Wound dehiscence

  Development of wound dehiscence during follow-up period

  12 weeks

• Patient Satisfaction

  Measurement of patient satisfaction of post-operative ability to shower based on administration of a satisfaction survey

  12 weeks

Study Arms (2)

Study Arm 1

ACTIVE COMPARATOR

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.

Other: Showering

Study Arm 2

ACTIVE COMPARATOR

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.

Other: Restriction of Showering

Interventions

Showering OTHER

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

Study Arm 1

Restriction of Showering OTHER

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

Study Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sean Devitt: lead

Study Sites (1)

Geisinger Health

Danville, Pennsylvania, 17822, United States

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection; Postoperative Complications

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sean Devitt, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean Devitt, MD

CONTACT

570-271-6335; sdevitt@geisinger.edu

Samantha Crissinger, BS

CONTACT

570-271-7499; srcrissinger@geisinger.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 27, 2021
• Study Start: February 23, 2022
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): July 15, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)