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

Not Applicable

Completed

• Conditions: Perforated Appendicitis
• Interventions: Drug: Normal Saline; Drug: Superoxidized Water

• Registration Number: NCT04512196
• Lead Sponsor: Hospital Queen Elizabeth, Malaysia

Brief 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.

Study Timeline

• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-13
• Study Start: 2020-09-09
• Primary Completion: 2022-03-11
• Study Completion: 2022-04-11
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal Saline	Peritoneal lavage with normal saline 0.9% of at least 10 cc/kg and wound lavage with normal saline 0.9% 1 cc/kg
Super-oxidised Solution	Superoxidized Water	Peritoneal lavage with super-oxidised solution of at least 10 cc/kg and wound lavage with super-oxidised solution 1 cc/kg

Primary Outcome Measures

Name	Time	Method
Surgical site infection	30 days post surgery	Number of participants with surgical site infection after open surgery for perforated appendicitis

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Queen Elizabeth; 🇲🇾 Kota Kinabalu, Sabah, Malaysia