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

Perforated Appendicitis Clinical Trial

— PLaSSo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512196
• Other study ID #: NMRR-ID-16-2905-30891
• Status: Completed
• Phase: N/A
• Start date: September 9, 2020
• Est. completion date: April 11, 2022

Study information

• Verified date: May 2022
• Source: Hospital Queen Elizabeth, Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 11, 2022
• Est. primary completion date: March 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Appendicitis
• Infections
• Perforated Appendicitis
• Surgical Wound Infection

Intervention

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.
• Normal Saline
Normal saline contains 0.9% sodium chloride.

Locations

Country	Name	City	State
Malaysia	Hospital Queen Elizabeth	Kota Kinabalu	Sabah

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Queen Elizabeth, Malaysia	Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (2)

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. — View Citation

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:CD012234. doi: 10.1002/14651858.CD012234.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection	Number of participants with surgical site infection after open surgery for perforated appendicitis	30 days post surgery
Secondary	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
Secondary	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