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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-09

Study Completion Date

2022-04-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Investigation of Oxidative Stress in Appendectomy - Open Versus Laparoscopic in Childhood and Adolescence

NCT03723642

Appendicitis Acute

UNKNOWN NA

Study on Laparoscopic Operation for Perforated Appendicitis

NCT00677989

Perforated Appendicitis

UNKNOWN

Title: Povidone-soaked Sutures Versus Ordinary Sutures for Reducing Surgical Site Infection

NCT05090176

Efficacy Povidone Soaked Suture in Reducing Surgical Site Infection

UNKNOWN NA

Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: a Multi-center Stepped Wedge Cluster Randomized Study

NCT04200729

Acute, Perforated Appendicitis

NOT_YET_RECRUITING PHASE4

Outcomes of High-volume Saline Irrigation VS Povidone-Iodine Solution Cleaning of IOWI in Preventing SSIs in Emergency Laparotomies

NCT05989386

Surgical Site Infection Surgical Wound Surgical Incision +5 more

RECRUITING PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Perforated Appendicitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Super-oxidised Solution

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

Group Type EXPERIMENTAL

Superoxidized Water

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Normal saline contains 0.9% sodium chloride.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Normal Saline

Normal saline contains 0.9% sodium chloride.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Hydrocyn Aqua® (Vigilenz MD., Penang, Malaysia); FDA 510(K) Number: K142775

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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