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

Postoperative Complications Clinical Trial

— SHOWER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04725916
• Other study ID #: 2020-0970
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: December 15, 2024

Study information

• Verified date: August 2023
• Source: Geisinger Clinic
• Contact: Sean Devitt, MD
• Phone: 570-271-6335
• Email: sdevitt[@]geisinger.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Drain Site Complication
• Infections
• Postoperative Complications
• Postoperative Wound Infection
• Surgical Site Infection
• Surgical Wound Infection
• Wound Infection

Intervention

Other:
• Showering
Patients will be instructed to shower after surgery with drains in place
• Restriction of Showering
Patients will be restricted from showering post operatively if they have drains in place

Locations

Country	Name	City	State
United States	Geisinger Health	Danville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sean Devitt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Wound dehiscence	Development of wound dehiscence during follow-up period	12 weeks
Primary	Patient Satisfaction	Measurement of patient satisfaction of post-operative ability to shower based on administration of a satisfaction survey	12 weeks