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Early Versus Delayed Bathing of Orthopaedic Surgical Wounds (EVDB)

Primary Purpose

Surgical Wound, Post Operative Wound Infection

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Time to bathing (delayed)
Time to bathing (early)
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Surgical Wound

Eligibility Criteria

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

Inclusion Criteria: Patients over 18 years of age Patient who are not pregnant Isolated acute fractures of the upper or lower extremities (humerus, radius, ulna, femur, tibia, or fibula) Diagnosis of a fracture meeting indication for operative intervention Any fracture not requiring a splint for post-operative management Non-complicated wounds (non-traumatic wounds, closed injuries, fractures not requiring external fixation, and acute fracture surgery) Exclusion Criteria: Fractures associated with presumed infection Patients with multiple fractures Fractures in patients with underlying associated immune compromise Fractures in patients with underlying peripheral vascular disease Use of VAC Surgery performed through previous surgical wound Patient homeless Fractures in patients with underlying diabetes mellitus Complicated wounds (traumatic wounds, need for post-op wound care, open injuries, need for external fixation)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Delayed Bathing

    Early Bathing

    Arm Description

    Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).

    Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.

    Outcomes

    Primary Outcome Measures

    Patient satisfaction associated with early and delayed surgical site bathing
    The primary endpoint of the study will be a statistically significant difference in patient satisfaction as measured using a Likert Scale between the two groups. Scale will be on scale 0-10. A score of 10 will be "Very Satisfied" and a score of 0 will be "Very Dissatisfied."

    Secondary Outcome Measures

    Infection rate of orthopaedic surgical wounds between early and delayed bathing
    The secondary endpoint in this study will be a statistically significant or clinically important difference in infection rate of orthopaedic surgical wounds between the early and delayed bathing groups

    Full Information

    First Posted
    August 21, 2023
    Last Updated
    September 12, 2023
    Sponsor
    Hospital for Special Surgery, New York
    Collaborators
    New York Presbyterian Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06014411
    Brief Title
    Early Versus Delayed Bathing of Orthopaedic Surgical Wounds
    Acronym
    EVDB
    Official Title
    Early Versus Delayed Bathing of Orthopaedic Surgical Wounds: a Prospective Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    August 25, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital for Special Surgery, New York
    Collaborators
    New York Presbyterian Hospital

    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 single center randomized control trial assessing the effect of early versus delayed bathing on orthopaedic surgical wounds in patients undergoing surgical treatment of fractures. Patients will be recruited by screening all patients undergoing surgical treatment for fractures at our institution. Patients who provide written consent will be randomized to one of two treatment arms after confirming eligibility criteria. Group A will be advised to begin early normal bathing (non-submerged showering) with uncovered surgical wounds. Group B will be advised to follow traditional delayed bathing with covered wounds.
    Detailed Description
    The study is a single center, non-inferiority, parallel group, randomized control trial assessing the effect of early versus delayed bathing on orthopaedic surgical wounds in patients undergoing surgical treatment of fractures. Patients will be recruited by screening all patients undergoing surgical treatment for fractures at our institution. Patients who provide written consent will be randomized to one of two treatment arms after confirming eligibility criteria. Group A will be advised to begin early normal bathing (non-submerged showering) with uncovered surgical wounds. Group B will be advised to follow traditional delayed bathing with covered wounds. Patients will have follow-up with data collection at two, six and 12 weeks post-operatively. The primary outcome measure will be patient satisfaction as measured by a Likert Scale. The Likert Scale as utilized will be a patient reported outcome measure consisting of one question allowing the subject to express their attitude towards a particular subject: "How satisfied are you with your surgical treatment" with possible answers consisting of: "very satisfied", "somewhat satisfied", "neutral", "somewhat unsatisfied", and "very unsatisfied". The secondary outcome measures will be development of an infection (subcategorized as either superficial or deep) and development of peri-incisional inflammation (eg. adhesive rash). Primary Objective: The primary objective of the study is to compare patient satisfaction as measured using a Likert Scale associated with early and delayed surgical site bathing. Secondary Objectives: The secondary objective is to compare the infection rate of orthopaedic surgical wounds between early and delayed bathing.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgical Wound, Post Operative Wound Infection

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    56 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Delayed Bathing
    Arm Type
    Active Comparator
    Arm Description
    Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).
    Arm Title
    Early Bathing
    Arm Type
    Active Comparator
    Arm Description
    Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.
    Intervention Type
    Other
    Intervention Name(s)
    Time to bathing (delayed)
    Intervention Description
    Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).
    Intervention Type
    Other
    Intervention Name(s)
    Time to bathing (early)
    Intervention Description
    Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.
    Primary Outcome Measure Information:
    Title
    Patient satisfaction associated with early and delayed surgical site bathing
    Description
    The primary endpoint of the study will be a statistically significant difference in patient satisfaction as measured using a Likert Scale between the two groups. Scale will be on scale 0-10. A score of 10 will be "Very Satisfied" and a score of 0 will be "Very Dissatisfied."
    Time Frame
    Weeks 2, 6 and 12 post surgery
    Secondary Outcome Measure Information:
    Title
    Infection rate of orthopaedic surgical wounds between early and delayed bathing
    Description
    The secondary endpoint in this study will be a statistically significant or clinically important difference in infection rate of orthopaedic surgical wounds between the early and delayed bathing groups
    Time Frame
    Weeks 12 post surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients over 18 years of age Patient who are not pregnant Isolated acute fractures of the upper or lower extremities (humerus, radius, ulna, femur, tibia, or fibula) Diagnosis of a fracture meeting indication for operative intervention Any fracture not requiring a splint for post-operative management Non-complicated wounds (non-traumatic wounds, closed injuries, fractures not requiring external fixation, and acute fracture surgery) Exclusion Criteria: Fractures associated with presumed infection Patients with multiple fractures Fractures in patients with underlying associated immune compromise Fractures in patients with underlying peripheral vascular disease Use of VAC Surgery performed through previous surgical wound Patient homeless Fractures in patients with underlying diabetes mellitus Complicated wounds (traumatic wounds, need for post-op wound care, open injuries, need for external fixation)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    William M Ricci, MD
    Phone
    212-606-1026
    Email
    ricciw@hss.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Craig E Klinger, BA
    Phone
    212-606-1641
    Email
    klingerc@hss.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    William M Ricci, MD
    Organizational Affiliation
    Hospital for Special Surgery, New York
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Early Versus Delayed Bathing of Orthopaedic Surgical Wounds

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