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

NCT04512196 | Completed

• 1 other identifier: NMRR-ID-16-2905-30891
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Perforated Appendicitis

Keywords

Perforated Appendicitis; Super-oxidised solution; Surgical site infection; Peritoneal lavage

Outcome Measures

Primary Outcomes (1)

• Surgical site infection

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

  30 days post surgery

Secondary Outcomes (2)

• Inflammatory marker C-reactive protein

  24 and 48 hours post surgery

• Post-operative Ileus

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

Study Arms (2)

Super-oxidised Solution

EXPERIMENTAL

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

Normal Saline

PLACEBO COMPARATOR

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

Interventions

Superoxidized Water DRUG

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.

Also known as: Hydrocyn Aqua® (Vigilenz MD., Penang, Malaysia); FDA 510(K) Number: K142775

Super-oxidised Solution

Normal Saline DRUG

Normal saline contains 0.9% sodium chloride.

Normal Saline

Eligibility Criteria

• Age: 13 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the age 13 and 70 years
• Diagnosed with perforated appendicitis intra-operatively
• Undergo open appendicectomy via Lanz incision

You may not qualify if:

• Surgical technique: Laparoscopic appendicectomy or mid-line laparotomy
• Patients on steroid treatment and immunosuppressant therapy.

Sponsors & Collaborators

• Hospital Queen Elizabeth, Malaysia: lead
• Ministry of Health, Malaysia: collaborator

Study Sites (1)

Hospital Queen Elizabeth

Kota Kinabalu, Sabah, 88300, Malaysia

Location

Related Publications (3)

• 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.

  PMID: 29083473 BACKGROUND

• 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.

  PMID: 25387655 BACKGROUND

• Sellappan H, Alagoo D, Loo C, Vijian K, Sibin R, Chuah JA. Effect of peritoneal and wound lavage with super-oxidized solution on surgical-site infection after open appendicectomy in perforated appendicitis (PLaSSo): randomized clinical trial. BJS Open. 2024 Sep 3;8(5):zrae121. doi: 10.1093/bjsopen/zrae121.

  PMID: 39413050 DERIVED

MeSH Terms

Conditions

Appendicitis; Surgical Wound Infection

Interventions

superoxidized water; Saline Solution

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hari Sellappan, MB BCh BAO

  Hospital Queen Elizabeth, Kota Kinabalu, Sabah, Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study participants, healthcare providers who attend to the participants during the trial (surgeon and nurses), outcome evaluators (surgical doctors and nurses) and data collectors will be blinded to the allocation. The sterile study solution (super-oxidised solution) or placebo (normal saline 0.9%) will be stored in a similar storage container and will have the same clear appearance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomised double-blind placebo-controlled parallel-group study. This is a superiority study assessing the effectiveness of the intervention

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: August 13, 2020
• Study Start: September 9, 2020
• Primary Completion: March 11, 2022
• Study Completion: April 11, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)