Clincosm LogoSign in Get a demo

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

Sponsor
Hospital Queen Elizabeth, Malaysia (Other)
Overall Status
Completed
CT.gov ID
NCT04512196
Collaborator
Ministry of Health, Malaysia (Other)
102
Enrollment
1
Location
2
Arms
19
Actual Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Superoxidized Water
  • Drug: Normal Saline
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomised double-blind placebo-controlled parallel-group study. This is a superiority study assessing the effectiveness of the interventionRandomised double-blind placebo-controlled parallel-group study. This is a superiority study assessing the effectiveness of the intervention
Masking:
Quadruple (Participant, Care Provider, 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.
Primary Purpose:
Treatment
Official Title:
Incidence of Surgical Site Infection in Perforated Appendicitis After Peritoneal Lavage With Super-oxidised Solution: A Randomised Double-blind, Placebo-controlled Trial
Actual Study Start Date :
Sep 9, 2020
Actual Primary Completion Date :
Mar 11, 2022
Actual Study Completion Date :
Apr 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

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

    		•
    Placebo Comparator: 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

    Drug: Normal Saline
    Normal saline contains 0.9% sodium chloride.

    Outcome Measures

    Primary Outcome Measures

    1. Surgical site infection [30 days post surgery]

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

    Secondary Outcome Measures

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Queen Elizabeth Kota Kinabalu Sabah Malaysia 88300

    Sponsors and Collaborators

    • Hospital Queen Elizabeth, Malaysia
    • Ministry of Health, Malaysia

    Investigators

    • Principal Investigator: Hari Sellappan, MB BCh BAO, Hospital Queen Elizabeth, Kota Kinabalu, Sabah, Malaysia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hospital Queen Elizabeth, Malaysia
    ClinicalTrials.gov Identifier:
    NCT04512196
    Other Study ID Numbers:
    • NMRR-ID-16-2905-30891
    First Posted:
    Aug 13, 2020
    Last Update Posted:
    May 25, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hospital Queen Elizabeth, Malaysia
    Perforated Appendicitis
    Super-oxidised solution
    Surgical site infection
    Peritoneal lavage
    Additional relevant MeSH terms:
    Infections
    Appendicitis
    Surgical Wound Infection

    Study Results

    No Results Posted as of May 25, 2022