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
About this trial
This is an interventional prevention trial for Perioperative Hyperoxygenation focused on measuring PerioperativeHyperoxygenation, Wound Site Infection, Appendicitis
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.
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
NCT ID
NCT02687217
First Posted
February 9, 2016
Last Updated
April 2, 2016
Sponsor
Lady Hardinge Medical College
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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