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

Hospital Queen Elizabeth, Malaysia102 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

102

Conditions

Perforated Appendicitis

Interventions

Superoxidized WaterDRUG

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.

Normal SalineDRUG

Normal saline contains 0.9% sodium chloride.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients between the age 13 and 70 years 2. Diagnosed with perforated appendicitis intra-operatively 3. Undergo open appendicectomy via Lanz incision Exclusion Criteria: 1. Surgical technique: Laparoscopic appendicectomy or mid-line laparotomy 2. Patients on steroid treatment and immunosuppressant therapy.

Locations (1)

Hospital Queen Elizabeth

Kota Kinabalu, Sabah, Malaysia

Outcomes

Primary Outcomes

Surgical site infection

Number of participants with surgical site infection after open surgery for perforated appendicitis

Time frame: 30 days post surgery

Secondary Outcomes

Inflammatory marker C-reactive protein

Change in serum inflammatory marker C-reactive protein level after open surgery for perforated appendicitis

Time frame: 24 and 48 hours post surgery

Post-operative Ileus

Duration of post-operative ileus after open surgery for perforated appendicitis

Time frame: From end of surgery till first passage of flatus or bowel opening, whichever comes first, assessed up to 30 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.