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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Showering
Other interventionPatients will be instructed to shower after surgery with drains in place
Restriction of Showering
Other interventionPatients will be restricted from showering post operatively if they have drains in place
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sean Devitt
Lead sponsor
Geisinger Clinic
Sponsor institution