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

Lady Hardinge Medical College60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Perioperative Hyperoxygenation Wound Infection

Interventions

oxygenDRUG

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.

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

Number of Patients Requiring Additional Investigations

Sonography; Pus culture; blood culture; Total Leucocyte Count.

Time frame: 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

Time frame: 14 days

Data from ClinicalTrials.gov

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