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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSean Devitt

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients having one of the following procedures at Geisinger Medical Center in which drains are placed

Breast reduction

Lower panniculectomy

Fleur-de-lis panniculectomy

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Showering

    Other intervention

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

  • Restriction of Showering

    Other intervention

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Study Arm 1Active comparator 1 intervention
Group B: Study Arm 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 weeks
3

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.

Time frame
12 weeks
4

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.

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sean Devitt

Lead sponsor

Geisinger Clinic

Sponsor institution