Clinical trial NCT04725916: Studying How Outpatient Water AffEcts Risks with Drains (SHOWER Study)
Official title: Studying How Outpatient Water AffEcts Risks with Drains (SHOWER Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Drain site cellulitis
timeFrame: 12 weeks
measure: Incisional cellulitis
timeFrame: 12 weeks
measure: Seroma formation
timeFrame: 12 weeks
measure: Abscess formation
timeFrame: 12 weeks
measure: Wound dehiscence
timeFrame: 12 weeks
measure: Patient Satisfaction
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Health
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Sean Devitt, MD
role: PRINCIPAL_INVESTIGATOR
References: