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

Primary Purpose

Postoperative Wound Infection, Postoperative Complications, Surgical Site Infection

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Showering
Restriction of Showering
Sponsored by
Sean Devitt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Wound Infection focused on measuring Panniculectomy, Breast reduction surgery, Postoperative showering, Surgical drain, Fleur-de-lis panniculectomy, Massive weight loss surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Geisinger HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Study Arm 1

Study Arm 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Wound dehiscence
Development of wound dehiscence during follow-up period
Patient Satisfaction
Measurement of patient satisfaction of post-operative ability to shower based on administration of a satisfaction survey

Secondary Outcome Measures

Full Information

First Posted
January 20, 2021
Last Updated
August 31, 2023
Sponsor
Sean Devitt
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1. Study Identification

Unique Protocol Identification Number
NCT04725916
Brief Title
Studying How Outpatient Water affEcts Risks With Drains (SHOWER Study)
Acronym
SHOWER
Official Title
Studying How Outpatient Water affEcts Risks With Drains (SHOWER Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sean Devitt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Arm 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Study Arm 2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Showering
Intervention Description
Patients will be instructed to shower after surgery with drains in place
Intervention Type
Other
Intervention Name(s)
Restriction of Showering
Intervention Description
Patients will be restricted from showering post operatively if they have drains in place
Primary Outcome Measure Information:
Title
Drain site cellulitis
Description
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
Title
Incisional cellulitis
Description
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
Title
Seroma formation
Description
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
Title
Abscess formation
Description
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
Title
Wound dehiscence
Description
Development of wound dehiscence during follow-up period
Time Frame
12 weeks
Title
Patient Satisfaction
Description
Measurement of patient satisfaction of post-operative ability to shower based on administration of a satisfaction survey
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sean Devitt, MD
Phone
570-271-6335
Email
sdevitt@geisinger.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha Crissinger, BS
Phone
570-271-7499
Email
srcrissinger@geisinger.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Devitt, MD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Health
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Devitt, MD
Phone
570-271-6335
Email
sdevitt@geisinger.edu
First Name & Middle Initial & Last Name & Degree
Samantha Crissinger, BS
Phone
570-271-7499
Email
srcrissinger@geisinger.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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