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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.

Sponsor: Lady Hardinge Medical College

Current Primary Outcome: ASEPSIS Score [ Time Frame: 14 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Number of Patients Requiring Additional Investigations [ Time Frame: 14 days ]
  Sonography; Pus culture; blood culture; Total Leucocyte Count.
• Number of Patients Requiring Additional Treatment [ Time Frame: 14 days ]
  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

Original Secondary Outcome: Same as current

Information By: Lady Hardinge Medical College

Dates:
Date Received: February 9, 2016
Date Started: November 2011
Date Completion:
Last Updated: April 2, 2016
Last Verified: April 2016