Clinical Trials Directory

Trials / Completed

CompletedNCT02687217

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

Role of Perioperative Hyperoxygenation in Wound Infection Following Surgery for Acute Appendicitis: A Randomised Controlled Trial.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Lady Hardinge Medical College · Other Government
Sex
All
Age
15 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGoxygenHyperoxygenation ≥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.

Timeline

Start date
2011-11-01
Primary completion
2013-03-01
Completion
2013-05-01
First posted
2016-02-22
Last updated
2016-05-06
Results posted
2016-05-06

Source: ClinicalTrials.gov record NCT02687217. Inclusion in this directory is not an endorsement.