NCT04512196

Surgical Site Infection in Perforated Appendicitis After Peritoneal Lavage With Super-oxidised Solution

Incidence of Surgical Site Infection in Perforated Appendicitis After Peritoneal Lavage With Super-oxidised Solution: A Randomised Double-blind, Placebo-controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Hospital Queen Elizabeth, Malaysia · Other Government
• Sex: All
• Age: 13 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the effectiveness of peritoneal lavage with super-oxidised solution in reducing surgical site infection after open surgery for perforated appendicitis.

Detailed description

Open appendicectomy for perforated appendicitis is associated with significant morbidity from surgical site infection. The standard practice is to perform peritoneal and wound lavage using normal saline solution. The investigators propose the use of superoxidized solution for peritoneal and wound lavage to decrease the incidence of surgical site infection. Superoxidized solutions contain hypochlorous acid (HOCl) which has bactericidal properties. The reactive oxygen species that is produces damages cell wall membrane of unicellular organisms, however remains safe when in contact with human or animal tissue. It is commonly used for topical treatment of wounds.

Conditions

• Perforated Appendicitis

Interventions

Type	Name	Description
DRUG	Superoxidized Water	Super-oxidized solution contains hypochlorous acid (HOCl) which exhibits bactericidal activity. These reactive species create an imbalanced osmotic gradient which damages the cell membrane integrity of single celled organisms, and subsequently denaturing its lipid and protein content. Multicellular organisms including host tissue are not susceptible to such changes in osmolarity hence spared from damage.
DRUG	Normal Saline	Normal saline contains 0.9% sodium chloride.

Timeline

• Start date: 2020-09-09
• Primary completion: 2022-03-11
• Completion: 2022-04-11
• First posted: 2020-08-13
• Last updated: 2022-05-25

Locations

1 site across 1 country: Malaysia