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

Lady Hardinge Medical College

Status: Completed

Conditions: Perioperative Hyperoxygenation; Wound Infection

Treatments: Drug: oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT02687217

LHMC/ECHR/2014/326

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Group A: Control

No Intervention group

Description:

Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively

Group B: Test

Experimental group

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.

Treatment:

Drug: oxygen