Perioperative Hyperoxygenation, Wound Infection
Conditions
Keywords
PerioperativeHyperoxygenation, Wound Site Infection, Appendicitis
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.
Interventions
DRUGoxygen
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.
Sponsors
Lady Hardinge Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ASEPSIS Score | 14 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Requiring Additional Investigations | 14 days | Sonography; Pus culture; blood culture; Total Leucocyte Count. |
| Number of Patients Requiring Additional Treatment | 14 days | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A: Control Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively | 30 |
| Group B: Test Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.
oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Group B: Test | Group A: Control | Total |
|---|---|---|---|
| Abdominal pain duration | 1.87 days STANDARD_DEVIATION 0.86 | 1.33 days STANDARD_DEVIATION 0.54 | 1.60 days STANDARD_DEVIATION 0.76 |
| Age, Customized 15-20 years | 8 participants | 7 participants | 15 participants |
| Age, Customized 21-25 years | 10 participants | 9 participants | 19 participants |
| Age, Customized 26-30 | 7 participants | 7 participants | 14 participants |
| Age, Customized 31-35 | 2 participants | 3 participants | 5 participants |
| Age, Customized 36-40 | 2 participants | 3 participants | 5 participants |
| Age, Customized 41-45 | 1 participants | 1 participants | 2 participants |
| Body Mass Index | 23.35 Kg/m^2 STANDARD_DEVIATION 4.25 | 22.71 Kg/m^2 STANDARD_DEVIATION 3.17 | 22.81 Kg/m^2 STANDARD_DEVIATION 3.7 |
| Body temperature | 98.67 degrees Fahrenheit STANDARD_DEVIATION 1.16 | 98.45 degrees Fahrenheit STANDARD_DEVIATION 1.01 | 98.56 degrees Fahrenheit STANDARD_DEVIATION 1.08 |
| Duration of surgery | 1.14 Hours STANDARD_DEVIATION 0.29 | 1.05 Hours STANDARD_DEVIATION 0.15 | 1.1 Hours STANDARD_DEVIATION 0.23 |
| Haemodynamic parameter Stable | 30 participants | 30 participants | 60 participants |
| Haemodynamic parameter unstable | 0 participants | 0 participants | 0 participants |
| Intraoperative bicarbonate | 23.60 mmol/L STANDARD_DEVIATION 3.39 | 23.12 mmol/L STANDARD_DEVIATION 1.2 | 23.36 mmol/L STANDARD_DEVIATION 2.53 |
| Intraoperative findings Acute Appendicitis | 26 participants | 29 participants | 55 participants |
| Intraoperative findings Gangrenous Appendicitis | 4 participants | 1 participants | 5 participants |
| Intraoperative oxygen saturation | 98.50 percentage of oxygenated haemoglobin STANDARD_DEVIATION 1.08 | 97.01 percentage of oxygenated haemoglobin STANDARD_DEVIATION 5.2 | 97.76 percentage of oxygenated haemoglobin STANDARD_DEVIATION 3.8 |
| Intraoperative partial pressure of arterial oxygen | 151.67 mmHg STANDARD_DEVIATION 2.88 | 86.53 mmHg STANDARD_DEVIATION 3.52 | 119 mmHg STANDARD_DEVIATION 3.86 |
| Intraoperative partial pressure of carbon dioxide | 36.16 mmHg STANDARD_DEVIATION 6.46 | 36.82 mmHg STANDARD_DEVIATION 2.78 | 36.49 mmHg STANDARD_DEVIATION 4.94 |
| Intraoperative pH | 7.40 pH STANDARD_DEVIATION 0.05 | 7.39 pH STANDARD_DEVIATION 0.03 | 7.39 pH STANDARD_DEVIATION 0.04 |
| length of hospital stay | 3.87 days STANDARD_DEVIATION 1 | 3.87 days STANDARD_DEVIATION 1 | 3.87 days STANDARD_DEVIATION 1 |
| Postoperative partial pressure of arterial oxygen | 137.6 mmhg STANDARD_DEVIATION 2.49 | 86.21 mmhg STANDARD_DEVIATION 3.85 | 119 mmhg STANDARD_DEVIATION 3.13 |
| Postoperative Total leucocyte count | 9.03 10^3 cells per mm^3 STANDARD_DEVIATION 2.1 | 8.16 10^3 cells per mm^3 STANDARD_DEVIATION 1.17 | 8.6 10^3 cells per mm^3 STANDARD_DEVIATION 1.74 |
| Preoperative Haemoglobin | 13.07 g/dL STANDARD_DEVIATION 1.57 | 12.87 g/dL STANDARD_DEVIATION 1.17 | 12.97 g/dL STANDARD_DEVIATION 1.38 |
| Preoperative Total leucocyte count | 13.30 10^3 cells per mm^3 STANDARD_DEVIATION 3.65 | 12.20 10^3 cells per mm^3 STANDARD_DEVIATION 1.71 | 12.75 10^3 cells per mm^3 STANDARD_DEVIATION 2.88 |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 23 Participants | 23 Participants | 46 Participants |
| Use of antibiotics | 5.60 days STANDARD_DEVIATION 1.27 | 5.26 days STANDARD_DEVIATION 1.11 | 5.43 days STANDARD_DEVIATION 1.19 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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.
Time frame: 14 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: Control | ASEPSIS Score | Disturbance of healing | 0 participants |
| Group A: Control | ASEPSIS Score | Moderate wound infection | 0 participants |
| Group A: Control | ASEPSIS Score | Minor wound infection | 0 participants |
| Group A: Control | ASEPSIS Score | Severe wound infection | 0 participants |
| Group A: Control | ASEPSIS Score | Satisfactory healing | 30 participants |
| Group B: Test | ASEPSIS Score | Severe wound infection | 0 participants |
| Group B: Test | ASEPSIS Score | Satisfactory healing | 30 participants |
| Group B: Test | ASEPSIS Score | Disturbance of healing | 0 participants |
| Group B: Test | ASEPSIS Score | Minor wound infection | 0 participants |
| Group B: Test | ASEPSIS Score | Moderate wound infection | 0 participants |
p-value: 0.5Wilcoxon (Mann-Whitney)
Secondary
Number of Patients Requiring Additional Investigations
Sonography; Pus culture; blood culture; Total Leucocyte Count.
Time frame: 14 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: Control | Number of Patients Requiring Additional Investigations | Required | 0 participants |
| Group A: Control | Number of Patients Requiring Additional Investigations | Not required | 30 participants |
| Group B: Test | Number of Patients Requiring Additional Investigations | Required | 0 participants |
| Group B: Test | Number of Patients Requiring Additional Investigations | Not required | 30 participants |
p-value: 0.5Chi-squared
Secondary
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
Time frame: 14 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: Control | Number of Patients Requiring Additional Treatment | Not required | 30 participants |
| Group A: Control | Number of Patients Requiring Additional Treatment | Required | 0 participants |
| Group B: Test | Number of Patients Requiring Additional Treatment | Not required | 30 participants |
| Group B: Test | Number of Patients Requiring Additional Treatment | Required | 0 participants |
p-value: 0.5Chi-squared