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

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

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.

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.

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

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.

Peritoneal lavage with super-oxidised solution of at least 10 cc/kg and wound lavage with super-oxidised solution 1 cc/kg

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-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.

Change in serum inflammatory marker C-reactive protein level 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

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.

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.