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.

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.

Study Overview

• Status: Completed
• Conditions: Wound Infection; Perioperative Hyperoxygenation
• Intervention / Treatment: Drug: oxygen

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group A: Control; Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
Experimental: 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.	Drug: oxygen; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	14 days

Collaborators and Investigators

• Sponsor: Lady Hardinge Medical College
• Investigators: Principal Investigator: Swati Sattavan, M.S., Lady Hardinge Medical College and Associated Hospitals

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: February 16, 2016
• First Posted (Estimate): February 22, 2016

Study Record Updates

• Last Update Posted (Estimate): May 6, 2016
• Last Update Submitted That Met QC Criteria: April 2, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Appendicitis; PerioperativeHyperoxygenation; Wound Site Infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Wound Infection
• Other Study ID Numbers: LHMC/ECHR/2014/326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided