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Roles of Prophylactic Subcutaneous Drain in Preventing Surgical Site Infection in Surgical Wound After Abdominal Surgery

Primary Purpose

Surgical Site Infection

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Subcutaneous drain
No drain
Sponsored by
Queen Savang Vadhana Memorial Hospital, Thailand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection

Eligibility Criteria

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

Inclusion Criteria: Age equal or over 18 years old Admitted to Queen Savang Vadhana Memorial Hospital Receive abdominal surgery and were classified as class 3 or 4 wound Exclusion Criteria: Patients who undergo operation for ostomy Patients who do not receive appropriate antibiotics Patients who undergo operation before full recover of prior operation Patients who undergo laparoscopic operation Pregnant women Patients who had history of prior radiation therapy at abdomen Patient with immunocompromised status Patient with chronic skin disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Subcutaneous drain

    No drain

    Arm Description

    The drain will be inserted into subcutaneous layer of the surgical wound. Redivac drain will be used in this study.

    No drain will be inserted into the surgical wound in this arm.

    Outcomes

    Primary Outcome Measures

    Rate of Surgical Site Infection (SSI)
    The rate of SSI will be compared between the drain and no drain group
    Rate of Surgical Site Infection (SSI)
    The rate of SSI will be compared between the drain and no drain group
    Rate of Surgical Site Infection (SSI)
    The rate of SSI will be compared between the drain and no drain group
    Rate of Surgical Site Infection (SSI)
    The rate of SSI will be compared between the drain and no drain group
    Rate of Surgical Site Infection (SSI)
    The rate of SSI will be compared between the drain and no drain group

    Secondary Outcome Measures

    Length of hospital stay
    The length of hospital stay will be compared between drain and no drain group
    Length of hospital stay
    The length of hospital stay will be compared between drain and no drain group
    Length of hospital stay
    The length of hospital stay will be compared between drain and no drain group
    Length of hospital stay
    The length of hospital stay will be compared between drain and no drain group
    Length of hospital stay
    The length of hospital stay will be compared between drain and no drain group

    Full Information

    First Posted
    September 22, 2023
    Last Updated
    October 6, 2023
    Sponsor
    Queen Savang Vadhana Memorial Hospital, Thailand
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06063629
    Brief Title
    Roles of Prophylactic Subcutaneous Drain in Preventing Surgical Site Infection in Surgical Wound After Abdominal Surgery
    Official Title
    Roles of Prophylactic Subcutaneous Drain in Preventing Surgical Site Infection in Abdominal Surgery Wound Class III and IV
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    February 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Queen Savang Vadhana Memorial Hospital, Thailand

    4. Oversight

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

    5. Study Description

    Brief Summary
    Surgical site infections (SSI) pose a common challenge in the field of surgery. Current evidence and literature do not provide clear consensus whether the use of subcutaneous drainage will help reduce the incidence of SSI in patients who underwent abdominal surgery, especially in wounds that are categorized as contaminated (class 3) or dirty/infected (class 4). The objective of this clinical study is to compare the rate of surgical site infection in contaminated and dirty/infected surgical wounds among patients whose wounds are inserted with subcutaneous drainage and patients who are not inserted with subcutaneous drainage.
    Detailed Description
    This study is a randomized, controlled and open study, where participants who undergo abdominal surgery will be randomly allocated into two groups: (i) patients whose wounds are inserted with subcutaneous negative pressure drain and (ii) patients whose wounds are not inserted with subcutaneous negative pressure drain. The participants in this study will know the details about the presence of their drain placement after the operation. If the patient was assigned to the drain group, the drain will be placed for five days or until there are no content observed in the drain. The primary outcome of this study is the occurrence of SSI, which will be tracked up to 30 days post-operation. The patient in both groups will also be evaluated by the surgeons at day 3, 5, 7, 14 and 30 post-operation for signs and complications of SSI. In situation where the patients are discharged prior to the date of evaluation, the patients will be scheduled for evaluation during the follow-up visits. If SSI is detected in the drain group prior to removal, the drain will be removed and the patient will be treated with wet dressing combined with antibiotics. Complications of SSI will also be noted. Patient's data on demographic, medical history, clinical presentation, details of operation, and other laboratory findings will also be collected to investigate for risk factors for development of SSI between each group.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Minimization randomization
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Subcutaneous drain
    Arm Type
    Experimental
    Arm Description
    The drain will be inserted into subcutaneous layer of the surgical wound. Redivac drain will be used in this study.
    Arm Title
    No drain
    Arm Type
    Other
    Arm Description
    No drain will be inserted into the surgical wound in this arm.
    Intervention Type
    Procedure
    Intervention Name(s)
    Subcutaneous drain
    Intervention Description
    The drain will be inserted into subcutaneous layer of the surgical wound. Redivac drain will be used in this study.
    Intervention Type
    Procedure
    Intervention Name(s)
    No drain
    Intervention Description
    No drain will be inserted into patients allocated to this group
    Primary Outcome Measure Information:
    Title
    Rate of Surgical Site Infection (SSI)
    Description
    The rate of SSI will be compared between the drain and no drain group
    Time Frame
    Post operation day 3
    Title
    Rate of Surgical Site Infection (SSI)
    Description
    The rate of SSI will be compared between the drain and no drain group
    Time Frame
    Post operation day 5
    Title
    Rate of Surgical Site Infection (SSI)
    Description
    The rate of SSI will be compared between the drain and no drain group
    Time Frame
    Post operation day 7
    Title
    Rate of Surgical Site Infection (SSI)
    Description
    The rate of SSI will be compared between the drain and no drain group
    Time Frame
    Post operation day 14
    Title
    Rate of Surgical Site Infection (SSI)
    Description
    The rate of SSI will be compared between the drain and no drain group
    Time Frame
    Post operation day 30
    Secondary Outcome Measure Information:
    Title
    Length of hospital stay
    Description
    The length of hospital stay will be compared between drain and no drain group
    Time Frame
    Post operation day 3
    Title
    Length of hospital stay
    Description
    The length of hospital stay will be compared between drain and no drain group
    Time Frame
    Post operation day 5
    Title
    Length of hospital stay
    Description
    The length of hospital stay will be compared between drain and no drain group
    Time Frame
    Post operation day 7
    Title
    Length of hospital stay
    Description
    The length of hospital stay will be compared between drain and no drain group
    Time Frame
    Post operation day 14
    Title
    Length of hospital stay
    Description
    The length of hospital stay will be compared between drain and no drain group
    Time Frame
    Post operation day 30

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age equal or over 18 years old Admitted to Queen Savang Vadhana Memorial Hospital Receive abdominal surgery and were classified as class 3 or 4 wound Exclusion Criteria: Patients who undergo operation for ostomy Patients who do not receive appropriate antibiotics Patients who undergo operation before full recover of prior operation Patients who undergo laparoscopic operation Pregnant women Patients who had history of prior radiation therapy at abdomen Patient with immunocompromised status Patient with chronic skin disease

    12. IPD Sharing Statement

    Learn more about this trial

    Roles of Prophylactic Subcutaneous Drain in Preventing Surgical Site Infection in Surgical Wound After Abdominal Surgery

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