Perforated Appendicitis
Conditions
Keywords
Perforated Appendicitis, Super-oxidised solution, Surgical site infection, Peritoneal lavage
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.
Interventions
DRUGSuperoxidized 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.
DRUGNormal Saline
Normal saline contains 0.9% sodium chloride.
Sponsors
Ministry of Health, Malaysia
Hospital Queen Elizabeth, Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Randomised double-blind placebo-controlled parallel-group study. This is a superiority study assessing the effectiveness of the intervention
Eligibility
Sex/Gender
ALL
Age
13 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infection | 30 days post surgery | Number of participants with surgical site infection after open surgery for perforated appendicitis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory marker C-reactive protein | 24 and 48 hours post surgery | Change in serum inflammatory marker C-reactive protein level after open surgery for perforated appendicitis |
| Post-operative Ileus | From end of surgery till first passage of flatus or bowel opening, whichever comes first, assessed up to 30 days | Duration of post-operative ileus after open surgery for perforated appendicitis |
Countries
Malaysia
Outcome results
None listed