Trial Outcomes & Findings for Effect of Peri-operative Supplemental Oxygen in Wound Infection After Appendectomy (NCT NCT02687217)
NCT ID: NCT02687217
Last Updated: 2016-05-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
14 days
Results posted on
2016-05-06
Participant Flow
Participant milestones
| Measure |
Group A: Control
Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Peri-operative Supplemental Oxygen in Wound Infection After Appendectomy
Baseline characteristics by cohort
| Measure |
Group A: Control
n=30 Participants
Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
|
Group B: Test
n=30 Participants
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.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
15-20 years
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Age, Customized
21-25 years
|
9 participants
n=99 Participants
|
10 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Age, Customized
26-30
|
7 participants
n=99 Participants
|
7 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Age, Customized
31-35
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Age, Customized
36-40
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Age, Customized
41-45
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Body Mass Index
|
22.71 Kg/m^2
STANDARD_DEVIATION 3.17 • n=99 Participants
|
23.35 Kg/m^2
STANDARD_DEVIATION 4.25 • n=107 Participants
|
22.81 Kg/m^2
STANDARD_DEVIATION 3.7 • n=206 Participants
|
|
Body temperature
|
98.45 degrees Fahrenheit
STANDARD_DEVIATION 1.01 • n=99 Participants
|
98.67 degrees Fahrenheit
STANDARD_DEVIATION 1.16 • n=107 Participants
|
98.56 degrees Fahrenheit
STANDARD_DEVIATION 1.08 • n=206 Participants
|
|
Abdominal pain duration
|
1.33 days
STANDARD_DEVIATION 0.54 • n=99 Participants
|
1.87 days
STANDARD_DEVIATION 0.86 • n=107 Participants
|
1.60 days
STANDARD_DEVIATION 0.76 • n=206 Participants
|
|
Preoperative Haemoglobin
|
12.87 g/dL
STANDARD_DEVIATION 1.17 • n=99 Participants
|
13.07 g/dL
STANDARD_DEVIATION 1.57 • n=107 Participants
|
12.97 g/dL
STANDARD_DEVIATION 1.38 • n=206 Participants
|
|
Preoperative Total leucocyte count
|
12.20 10^3 cells per mm^3
STANDARD_DEVIATION 1.71 • n=99 Participants
|
13.30 10^3 cells per mm^3
STANDARD_DEVIATION 3.65 • n=107 Participants
|
12.75 10^3 cells per mm^3
STANDARD_DEVIATION 2.88 • n=206 Participants
|
|
Haemodynamic parameter
Stable
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
Haemodynamic parameter
unstable
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Intraoperative pH
|
7.39 pH
STANDARD_DEVIATION 0.03 • n=99 Participants
|
7.40 pH
STANDARD_DEVIATION 0.05 • n=107 Participants
|
7.39 pH
STANDARD_DEVIATION 0.04 • n=206 Participants
|
|
Intraoperative partial pressure of arterial oxygen
|
86.53 mmHg
STANDARD_DEVIATION 3.52 • n=99 Participants
|
151.67 mmHg
STANDARD_DEVIATION 2.88 • n=107 Participants
|
119 mmHg
STANDARD_DEVIATION 3.86 • n=206 Participants
|
|
Intraoperative partial pressure of carbon dioxide
|
36.82 mmHg
STANDARD_DEVIATION 2.78 • n=99 Participants
|
36.16 mmHg
STANDARD_DEVIATION 6.46 • n=107 Participants
|
36.49 mmHg
STANDARD_DEVIATION 4.94 • n=206 Participants
|
|
Intraoperative bicarbonate
|
23.12 mmol/L
STANDARD_DEVIATION 1.2 • n=99 Participants
|
23.60 mmol/L
STANDARD_DEVIATION 3.39 • n=107 Participants
|
23.36 mmol/L
STANDARD_DEVIATION 2.53 • n=206 Participants
|
|
Intraoperative oxygen saturation
|
97.01 percentage of oxygenated haemoglobin
STANDARD_DEVIATION 5.20 • n=99 Participants
|
98.50 percentage of oxygenated haemoglobin
STANDARD_DEVIATION 1.08 • n=107 Participants
|
97.76 percentage of oxygenated haemoglobin
STANDARD_DEVIATION 3.80 • n=206 Participants
|
|
Intraoperative findings
Acute Appendicitis
|
29 participants
n=99 Participants
|
26 participants
n=107 Participants
|
55 participants
n=206 Participants
|
|
Intraoperative findings
Gangrenous Appendicitis
|
1 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Duration of surgery
|
1.05 Hours
STANDARD_DEVIATION .15 • n=99 Participants
|
1.14 Hours
STANDARD_DEVIATION .29 • n=107 Participants
|
1.1 Hours
STANDARD_DEVIATION .23 • n=206 Participants
|
|
Postoperative partial pressure of arterial oxygen
|
86.21 mmhg
STANDARD_DEVIATION 3.85 • n=99 Participants
|
137.6 mmhg
STANDARD_DEVIATION 2.49 • n=107 Participants
|
119 mmhg
STANDARD_DEVIATION 3.13 • n=206 Participants
|
|
Postoperative Total leucocyte count
|
8.16 10^3 cells per mm^3
STANDARD_DEVIATION 1.17 • n=99 Participants
|
9.03 10^3 cells per mm^3
STANDARD_DEVIATION 2.10 • n=107 Participants
|
8.6 10^3 cells per mm^3
STANDARD_DEVIATION 1.74 • n=206 Participants
|
|
Use of antibiotics
|
5.26 days
STANDARD_DEVIATION 1.11 • n=99 Participants
|
5.60 days
STANDARD_DEVIATION 1.27 • n=107 Participants
|
5.43 days
STANDARD_DEVIATION 1.19 • n=206 Participants
|
|
length of hospital stay
|
3.87 days
STANDARD_DEVIATION 1 • n=99 Participants
|
3.87 days
STANDARD_DEVIATION 1 • n=107 Participants
|
3.87 days
STANDARD_DEVIATION 1 • n=206 Participants
|
PRIMARY outcome
Timeframe: 14 daysASEPSIS 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.
Outcome measures
| Measure |
Group A: Control
n=30 Participants
Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
|
Group B: Test
n=30 Participants
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.
|
|---|---|---|
|
ASEPSIS Score
Satisfactory healing
|
30 participants
|
30 participants
|
|
ASEPSIS Score
Disturbance of healing
|
0 participants
|
0 participants
|
|
ASEPSIS Score
Minor wound infection
|
0 participants
|
0 participants
|
|
ASEPSIS Score
Moderate wound infection
|
0 participants
|
0 participants
|
|
ASEPSIS Score
Severe wound infection
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 14 daysSonography; Pus culture; blood culture; Total Leucocyte Count.
Outcome measures
| Measure |
Group A: Control
n=30 Participants
Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
|
Group B: Test
n=30 Participants
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.
|
|---|---|---|
|
Number of Patients Requiring Additional Investigations
Required
|
0 participants
|
0 participants
|
|
Number of Patients Requiring Additional Investigations
Not required
|
30 participants
|
30 participants
|
SECONDARY outcome
Timeframe: 14 daysRequirement 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
Outcome measures
| Measure |
Group A: Control
n=30 Participants
Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
|
Group B: Test
n=30 Participants
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.
|
|---|---|---|
|
Number of Patients Requiring Additional Treatment
Required
|
0 participants
|
0 participants
|
|
Number of Patients Requiring Additional Treatment
Not required
|
30 participants
|
30 participants
|
Adverse Events
Group A: Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B: Test
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Swati Sattavan
Lady Hardinge Medical College and associated Hospitals
Phone: 9891777424
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place