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

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ClinicalTrials.gov Identifier: NCT04725916
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : February 25, 2022
Sponsor:
Information provided by (Responsible Party):
Sean Devitt, Geisinger Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postoperative Wound Infection Postoperative Complications Surgical Site Infection Drain Site Complication Other: Showering Other: Restriction of Showering Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Studying How Outpatient Water affEcts Risks With Drains (SHOWER Study)
Estimated Study Start Date : May 21, 2022
Estimated Primary Completion Date : August 15, 2023
Estimated Study Completion Date : December 15, 2023
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Study Arm 1
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.
 Other: Showering
Patients will be instructed to shower after surgery with drains in place
Active Comparator: Study Arm 2
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.
 Other: Restriction of Showering
Patients will be restricted from showering post operatively if they have drains in place


Outcome Measures
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Primary Outcome Measures :
  1. Drain site cellulitis [ Time Frame: 12 weeks ]
    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.

  2. Incisional cellulitis [ Time Frame: 12 weeks ]
    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.

  3. Seroma formation [ Time Frame: 12 weeks ]
    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.

  4. Abscess formation [ Time Frame: 12 weeks ]
    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.

  5. Wound dehiscence [ Time Frame: 12 weeks ]
    Development of wound dehiscence during follow-up period

  6. Patient Satisfaction [ Time Frame: 12 weeks ]
    Measurement of patient satisfaction of post-operative ability to shower based on administration of a satisfaction survey


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04725916


Contacts
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Contact: Sean Devitt, MD 570-271-6335 sdevitt@geisinger.edu
Contact: Samantha Crissinger, BS 570-271-7499 srcrissinger@geisinger.edu

Locations
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United States, Pennsylvania
Geisinger Health Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Sean Devitt, MD    570-271-6335    sdevitt@geisinger.edu   
Contact: Samantha Crissinger, BS    570-271-7499    srcrissinger@geisinger.edu   
Sponsors and Collaborators
Sean Devitt
Investigators
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Principal Investigator: Sean Devitt, MD Geisinger Clinic
More Information
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Responsible Party: Sean Devitt, Sponsor-Investigator, Geisinger Clinic
ClinicalTrials.gov Identifier: NCT04725916    
Other Study ID Numbers: 2020-0970
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: February 25, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sean Devitt, Geisinger Clinic:
Panniculectomy
Breast reduction surgery
Postoperative showering
 Surgical drain
Fleur-de-lis panniculectomy
Massive weight loss surgery
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Surgical Wound Infection
Wound Infection
 Postoperative Complications
Disease Attributes
Pathologic Processes