Intraoperative Oxygen Concentration on Incidence of Surgical Site Infection

NCT06108791 | Recruiting

• 1 other identifier: SSI32641
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical site infections (SSI) are the most common healthcare-associated infections and sources of morbidity and over-mortality. Factors that have been proven to reduce SSI include antimicrobial prophylaxis, maintenance of perioperative normothermia, avoidance of hyperglycemia, proper surgical techniques, and adequate pain relief postoperatively

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• Incidence of SSI

  \- the incidence of SSI postoperatively according to the Centers for Disease Control (CDC) criteria up to 30 days

  30 DAYS

Secondary Outcomes (1)

• Pulmonary complications

  14 days

Study Arms (2)

HIGH FIO2

ACTIVE COMPARATOR

will include 50 patients: each one will receive intraoperatively a high concentration of oxygen (80% oxygen + 20% air), following extubation, high-concentration oxygen supplementation will be maintained and given through non-rebreathing face mask with a reservoir at 10 L/min for 2 h.

Drug: FIO2=0.8

LOW FIO2

PLACEBO COMPARATOR

will include 50 patients: each one will receive intraoperatively standard concentration oxygen (33% oxygen + 66% air) followed by oxygen supplementation through the standard Venturi face mask of 30%

Drug: FIO2=0.33

Interventions

FIO2=0.8 DRUG

the concentration of intraoperative inspired fraction of oxygen is 80% oxygen + 20% air

HIGH FIO2

FIO2=0.33 DRUG

the concentration of intraoperative inspired fraction of oxygen is 33% oxygen + 66% air

LOW FIO2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- BMI of \<35 kg/m2
• scheduled for elective abdominal laparotomy/ laparoscopy under general anesthesia with an expected surgical time longer than 2 h.
• ASA I and II

You may not qualify if:

• \- Patients undergoing minor procedures, where the expected duration of surgery will be less than 1 hour.
• emergency surgeries for bowel obstruction.
• abdominal surgery for vascular or plastic indications.
• patients with a recent history of fever,
• patients with uncontrolled diabetes mellitus,
• patient with known immunological dysfunction (on steroids, decompensated liver disease, HIV, etc.).

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shimaa A Hassan

CONTACT

01002953253; shimaa.abbas@med.aun.edu.eg

Study Design

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

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: April 3, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)