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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Control | No Intervention | Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively | |
| Group B: Test | Experimental | Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxygen | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Requiring Additional Investigations | Sonography; Pus culture; blood culture; Total Leucocyte Count. | 14 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Swati Sattavan, M.S. | Lady Hardinge Medical College and Associated Hospitals | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Control | Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Group A: Control:
Group B: Test:
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: Control | Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | 14 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: Control | Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively |
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The study included a small sample size of 60 patients, randomized into equal study group and control group as the time limit restrictions of 12- 15 months as prescribed by the residency programme.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Swati Sattavan | Lady Hardinge Medical College and associated Hospitals | 9891777424 | 91 | swatisattavan@gmail.com |
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| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D059413 | Intraabdominal Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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|
| 14 days |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | Kg/m^2 |
|
| Body temperature | Mean | Standard Deviation | degrees Fahrenheit |
|
| Abdominal pain duration | Mean | Standard Deviation | days |
|
| Preoperative Haemoglobin | Mean | Standard Deviation | g/dL |
|
| Preoperative Total leucocyte count | Mean | Standard Deviation | 10^3 cells per mm^3 |
|
| Haemodynamic parameter | Stable: With normal haemodynamic parameter. Unstable: With deranged hemodynamic parameter. | Number | participants |
|
| Intraoperative pH | Mean | Standard Deviation | pH |
|
| Intraoperative partial pressure of arterial oxygen | Mean | Standard Deviation | mmHg |
|
| Intraoperative partial pressure of carbon dioxide | Mean | Standard Deviation | mmHg |
|
| Intraoperative bicarbonate | Mean | Standard Deviation | mmol/L |
|
| Intraoperative oxygen saturation | Mean | Standard Deviation | percentage of oxygenated haemoglobin |
|
| Intraoperative findings | Number | participants |
|
| Duration of surgery | Mean | Standard Deviation | Hours |
|
| Postoperative partial pressure of arterial oxygen | Mean | Standard Deviation | mmhg |
|
| Postoperative Total leucocyte count | Mean | Standard Deviation | 10^3 cells per mm^3 |
|
| Use of antibiotics | Mean | Standard Deviation | days |
|
| length of hospital stay | Mean | Standard Deviation | days |
|
|
|
|
| Secondary | Number of Patients Requiring Additional Investigations | Sonography; Pus culture; blood culture; Total Leucocyte Count. | Posted | Number | participants | 14 days |
|
|
|
|
| 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 | Posted | Number | participants | 14 days |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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. | 0 | 30 | 0 | 30 |
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| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |