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

Hospital Queen Elizabeth, Malaysia

Status: Completed

Conditions: Perforated Appendicitis

Treatments: Drug: Normal Saline; Drug: Superoxidized Water

Study type: Interventional

Funder types: Other

Identifiers

NCT04512196

NMRR-ID-16-2905-30891

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 13 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

102 participants in 2 patient groups, including a placebo group

Super-oxidised Solution

Experimental group

Description:

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

Treatment:

Drug: Superoxidized Water

Normal Saline

Placebo Comparator group

Description:

Peritoneal lavage with normal saline 0.9% of at least 10 cc/kg and wound lavage with normal saline 0.9% 1 cc/kg

Treatment:

Drug: Normal Saline