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

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

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.

Study Overview

• Status: Completed
• Conditions: Perforated Appendicitis
• Intervention / Treatment: Drug: Superoxidized Water; Drug: Normal Saline

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 Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Sabah
    • Kota Kinabalu, Sabah, Malaysia, 88300
      • Hospital Queen Elizabeth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 68 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Super-oxidised Solution; 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; 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.; Other Names: Hydrocyn Aqua® (Vigilenz MD., Penang, Malaysia); FDA 510(K) Number: K142775
Placebo Comparator: 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	Drug: Normal Saline; Normal saline contains 0.9% sodium chloride.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Queen Elizabeth, Malaysia
• Collaborators: Ministry of Health, Malaysia
• Investigators: Principal Investigator: Hari Sellappan, MB BCh BAO, Hospital Queen Elizabeth, Kota Kinabalu, Sabah, Malaysia

Publications and helpful links

General Publications

• Norman G, Atkinson RA, Smith TA, Rowlands C, Rithalia AD, Crosbie EJ, Dumville JC. Intracavity lavage and wound irrigation for prevention of surgical site infection. Cochrane Database Syst Rev. 2017 Oct 30;10(10):CD012234. doi: 10.1002/14651858.CD012234.pub2.
• Kubota A, Goda T, Tsuru T, Yonekura T, Yagi M, Kawahara H, Yoneda A, Tazuke Y, Tani G, Ishii T, Umeda S, Hirano K. Efficacy and safety of strong acid electrolyzed water for peritoneal lavage to prevent surgical site infection in patients with perforated appendicitis. Surg Today. 2015 Jul;45(7):876-9. doi: 10.1007/s00595-014-1050-x. Epub 2014 Nov 13.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Actual): March 11, 2022
• Study Completion (Actual): April 11, 2022

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Surgical site infection; Perforated Appendicitis; Super-oxidised solution; Peritoneal lavage
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Wound Infection; Cecal Diseases; Intraabdominal Infections; Infections; Surgical Wound Infection; Appendicitis
• Other Study ID Numbers: NMRR-ID-16-2905-30891

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No