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NCT Number: NCT04512196

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

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.

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Key information

Conditions

Perforated Appendicitis Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

13 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Queen Elizabeth

Kota Kinabalu, Sabah, 88300, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Superoxidized Water

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.

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

normal saline

Drug

Normal saline contains 0.9% sodium chloride.

Primary outcomes

  1. Surgical site infection

    Time frame: 30 days post surgery

    Number of participants with surgical site infection after open surgery for perforated appendicitis

Secondary outcomes

  1. Inflammatory marker C-reactive protein

    Time frame: 24 and 48 hours post surgery

    Change in serum inflammatory marker C-reactive protein level after open surgery for perforated appendicitis

  2. Post-operative Ileus

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospital Queen Elizabeth, Malaysia

Other Gov

Collaborators

  • Ministry of Health, Malaysia

Registry information

Official study title

Incidence of Surgical Site Infection in Perforated Appendicitis After Peritoneal Lavage With Super-oxidised Solution: A Randomised Double-blind, Placebo-controlled Trial

Acronym: PLaSSo

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 13, 2020
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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