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Effect of Peri-operative Supplemental Oxygen in Wound Infection After Appendectomy

Primary Purpose

Perioperative Hyperoxygenation, Wound Infection

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
oxygen
Sponsored by
Lady Hardinge Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Perioperative Hyperoxygenation focused on measuring PerioperativeHyperoxygenation, Wound Site Infection, Appendicitis

Eligibility Criteria

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

Inclusion Criteria:

  1. Clinical diagnosis or Radiological diagnosis of acute appendicitis.
  2. Appendectomy through the Mc Burney incision.

Exclusion Criteria:

  1. Patients with chronic obstructive pulmonary diseases.
  2. Immunodeficiency disease.
  3. Patients requiring midline incision.
  4. Patients requiring general anaesthesia after failure of spinal anaesthesia.
  5. Patients requiring higher oxygen in perioperative period.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Group A: Control

    Group B: Test

    Arm Description

    Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively

    Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.

    Outcomes

    Primary Outcome Measures

    ASEPSIS Score
    ASEPSIS score- Additional treatment; Serous discharge; Erythema; Purulent exudate; Separation of deep tissues; Isolation of bacteria; and Stay. A daily score of 20 or more considered evidence of infection. Category of infection: Total score of 0-10 satisfactory healing; 11-20 disturbance of healing; 21-30 minor wound infection; 31-40 moderate wound infection; > 40 severe wound infection.

    Secondary Outcome Measures

    Number of Patients Requiring Additional Investigations
    Sonography; Pus culture; blood culture; Total Leucocyte Count.
    Number of Patients Requiring Additional Treatment
    Requirement of antipyretics; increased dose/ duration of antibiotic usage other than standard protocol; need for change to higher antibiotics; requirement of drainage procedures for pus/ wound infections; requirement for additional dressing sessions

    Full Information

    First Posted
    February 9, 2016
    Last Updated
    April 2, 2016
    Sponsor
    Lady Hardinge Medical College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02687217
    Brief Title
    Effect of Peri-operative Supplemental Oxygen in Wound Infection After Appendectomy
    Official Title
    Role of Perioperative Hyperoxygenation in Wound Infection Following Surgery for Acute Appendicitis: A Randomised Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2011 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    May 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lady Hardinge Medical College

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The study evaluates the role of supplemental hyper-oxygenation given perioperatively on wound site infection after appendectomy. Half of the patients received ≥50% oxygen and half of them received no oxygen during the surgical procedure.
    Detailed Description
    Patient with the diagnosis of acute appendicitis of >15 years of age group, with no comorbidities who presented to surgical emergency in Dr. Ram Manohar Lohia Hospital were considered for the present study. 30 patients who fulfilled the inclusion criteria and who voluntarily consented for the study were randomly allocated to the two groups- Group A (control group) and Group B (study group). These patients were operated through Mc-Burney incision given in the right lower quadrant. Both the groups were comparable in their demographic and preoperative profile. The study group was given ≥50% of oxygen intraoperatively and the control group was given no oxygen. In postoperative period, oxygen was given to group A at the rate of 4 litre/minute (L/min) and group B at the rate of 6 litre/minute (L/min). The assessment of the wound was done by using ASEPSIS (Additional treatment; Serous discharge; Erythema; Purulent exudate; Separation of deep tissues; Isolation of bacteria; and Stay) score. A score of more than 20 is considered to be infected. Fever, raised total leucocyte count, positive pus culture, Ultrasound evidence of fluid collections, removal of sutures and duration of hospital stay were also measured for the evaluation of economic implications due to SSI.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Perioperative Hyperoxygenation, Wound Infection
    Keywords
    PerioperativeHyperoxygenation, Wound Site Infection, Appendicitis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A: Control
    Arm Type
    No Intervention
    Arm Description
    Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
    Arm Title
    Group B: Test
    Arm Type
    Experimental
    Arm Description
    Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.
    Intervention Type
    Drug
    Intervention Name(s)
    oxygen
    Intervention Description
    Hyperoxygenation ≥50% of oxygen by mask(non-rebreathing) was given through out the surgery. Received 6L/min of oxygen through venturimask upto 2 hours in post operative period. Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery.
    Primary Outcome Measure Information:
    Title
    ASEPSIS Score
    Description
    ASEPSIS score- Additional treatment; Serous discharge; Erythema; Purulent exudate; Separation of deep tissues; Isolation of bacteria; and Stay. A daily score of 20 or more considered evidence of infection. Category of infection: Total score of 0-10 satisfactory healing; 11-20 disturbance of healing; 21-30 minor wound infection; 31-40 moderate wound infection; > 40 severe wound infection.
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    Number of Patients Requiring Additional Investigations
    Description
    Sonography; Pus culture; blood culture; Total Leucocyte Count.
    Time Frame
    14 days
    Title
    Number of Patients Requiring Additional Treatment
    Description
    Requirement of antipyretics; increased dose/ duration of antibiotic usage other than standard protocol; need for change to higher antibiotics; requirement of drainage procedures for pus/ wound infections; requirement for additional dressing sessions
    Time Frame
    14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis or Radiological diagnosis of acute appendicitis. Appendectomy through the Mc Burney incision. Exclusion Criteria: Patients with chronic obstructive pulmonary diseases. Immunodeficiency disease. Patients requiring midline incision. Patients requiring general anaesthesia after failure of spinal anaesthesia. Patients requiring higher oxygen in perioperative period.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Swati Sattavan, M.S.
    Organizational Affiliation
    Lady Hardinge Medical College and Associated Hospitals
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Effect of Peri-operative Supplemental Oxygen in Wound Infection After Appendectomy

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