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

NCT02687217 | Completed Results DMC

• 1 other identifier: LHMC/ECHR/2014/326
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Perioperative Hyperoxygenation; Wound Infection

Keywords

PerioperativeHyperoxygenation; Wound Site Infection; Appendicitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Patients Requiring Additional Investigations

  14 days

• Number of Patients Requiring Additional Treatment

  14 days

Study Arms (2)

Group A: Control

NO INTERVENTION

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

Group B: Test

EXPERIMENTAL

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

Interventions

oxygen DRUG

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.

Group B: Test

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis or Radiological diagnosis of acute appendicitis.
• Appendectomy through the Mc Burney incision.

You may not qualify if:

• Patients with chronic obstructive pulmonary diseases.
• Immunodeficiency disease.
• Patients requiring midline incision.
• Patients requiring general anaesthesia after failure of spinal anaesthesia.
• Patients requiring higher oxygen in perioperative period.

Sponsors & Collaborators

• Lady Hardinge Medical College: lead

MeSH Terms

Conditions

Wound Infection; Appendicitis

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Infections; Intraabdominal Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Limitations and Caveats

The study included a small sample size of 60 patients, randomized into equal study group and control group as the time limit restrictions of 12- 15 months as prescribed by the residency programme.

Results Point of Contact

• Title: Dr. Swati Sattavan
• Organization: Lady Hardinge Medical College and associated Hospitals

swatisattavan@gmail.com

9891777424

Study Officials

• Swati Sattavan, M.S.

  Lady Hardinge Medical College and Associated Hospitals

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 22, 2016
• Study Start: November 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 6, 2016
• Results First Posted: May 6, 2016

Record last verified: 2016-04