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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Perforated Appendicitis

Intervention / Treatment
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* Drug: Superoxidized Water
* Drug: Normal Saline


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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised double-blind placebo-controlled parallel-group study. This is a superiority study assessing the effectiveness of the intervention
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Super-oxidised Solution<br>Peritoneal lavage with super-oxidised solution of at least 10 cc/kg and wound lavage with super-oxidised solution 1 cc/kg | Drug: Superoxidized Water<br>* 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.<br>* Other names: Hydrocyn Aqua® (Vigilenz MD., Penang, Malaysia); FDA 510(K) Number: K142775;|
| Placebo Comparator: Normal Saline<br>Peritoneal lavage with normal saline 0.9% of at least 10 cc/kg and wound lavage with normal saline 0.9% 1 cc/kg | Drug: Normal Saline<br>* Normal saline contains 0.9% sodium chloride.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection | Number of participants with surgical site infection after open surgery for perforated appendicitis | 30 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory marker C-reactive protein | Change in serum inflammatory marker C-reactive protein level after open surgery for perforated appendicitis | 24 and 48 hours post surgery | 
| Post-operative Ileus | Duration of post-operative ileus after open surgery for perforated appendicitis | From end of surgery till first passage of flatus or bowel opening, whichever comes first, assessed up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perforated Appendicitis, Super-oxidised solution, Surgical site infection, Peritoneal lavage