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

Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02687217
• Other study ID #: LHMC/ECHR/2014/326
• Status: Completed
• Phase: N/A
• First received: February 9, 2016
• Last updated: February 16, 2016
• Start date: November 2011
• Est. completion date: May 2013

Study information

• Verified date: February 2016
• Source: Lady Hardinge Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Perioperative Hyperoxygenation
• Wound Infection

Intervention

Drug:
• oxygen
Hyperoxygenation refers to provision of =50% of oxygen by mask(non-rebreathing) through out the surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lady Hardinge Medical College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of patients requiring additional Investigations	Sonography; Pus culture; blood culture; Total Leucocyte Count.	14 days	No
Secondary	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	No