Clinical trial NCT04512196: Surgical Site Infection in Perforated Appendicitis After Peritoneal Lavage With Super-oxidised Solution
Official title: Incidence of Surgical Site Infection in Perforated Appendicitis After Peritoneal Lavage With Super-oxidised Solution: A Randomised Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perforated Appendicitis
Keywords: Perforated Appendicitis
Super-oxidised solution
Surgical site infection
Peritoneal lavage
Lead sponsor: Hospital Queen Elizabeth, Malaysia
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Malaysia
First posted: 2020-08-13
Enrollment: 102
Sex: ALL
Minimum age (years): 13
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised double-blind placebo-controlled parallel-group study. This is a superiority study assessing the effectiveness of the intervention
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Surgical site infection
timeFrame: 30 days post surgery
Secondary outcomes:
measure: Inflammatory marker C-reactive protein
timeFrame: 24 and 48 hours post surgery
measure: Post-operative Ileus
timeFrame: From end of surgery till first passage of flatus or bowel opening, whichever comes first, assessed up to 30 days
Other outcomes:
Locations:
city: Kota Kinabalu
country: Malaysia
facility: Hospital Queen Elizabeth
state: Sabah
Study officials:
affiliation: Hospital Queen Elizabeth, Kota Kinabalu, Sabah, Malaysia
name: Hari Sellappan, MB BCh BAO
role: PRINCIPAL_INVESTIGATOR
References:
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(10):CD012234. doi: 10.1002/14651858.CD012234.pub2.
citation: 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.