Perforated AppendicitisPLaSSoNCT04512196
Surgical Site Infection in Perforated Appendicitis After Peritoneal Lavage With Super-oxidised Solution
A study testing Superoxidized Water and Normal Saline in people with Perforated Appendicitis, run by Hospital Queen Elizabeth, Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 70 years
- Conditions the study is for
- Perforated Appendicitis
- What is being tested?
- Superoxidized Water and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteMalaysia
- Study dates
- 9 Sep 2020to 11 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients between the age 13 and 70 years
- Diagnosed with perforated appendicitis intra-operatively
- Undergo open appendicectomy via Lanz incision
Who cannot join
- Surgical technique: Laparoscopic appendicectomy or mid-line laparotomy
- Patients on steroid treatment and immunosuppressant therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Surgical Site Infection in Perforated Appendicitis After Peritoneal Lavage With Super-oxidised Solution: A Randomised Double-blind, Placebo-controlled Trial
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.
Read the 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.
- Conditions
- Perforated Appendicitis
- Being tested
- Superoxidized Water, Normal Saline
- Keywords
- Perforated Appendicitis, Super-oxidised solution, Surgical site infection, Peritoneal lavage
- Medical subject headings
- Appendicitis, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superoxidized WaterDrug
Also called Hydrocyn Aqua® (Vigilenz MD., Penang, Malaysia); FDA 510(K) Number: K142775
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 SalineDrug
Normal saline contains 0.9% sodium chloride.
| Study group | Role | What they receive |
|---|---|---|
| Super-oxidised Solution | Experimental | Peritoneal lavage with super-oxidised solution of at least 10 cc/kg and wound lavage with super-oxidised solution 1 cc/kg Receives: Drug: Superoxidized Water |
| Normal Saline | Placebo comparator | Peritoneal lavage with normal saline 0.9% of at least 10 cc/kg and wound lavage with normal saline 0.9% 1 cc/kg Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Number of participants with surgical site infection after open surgery for perforated appendicitis
Measured: 30 days post surgery
Secondary outcomes (2)
Inflammatory marker C-reactive protein
Change in serum inflammatory marker C-reactive protein level after open surgery for perforated appendicitis
Measured: 24 and 48 hours post surgery
Post-operative Ileus
Duration of post-operative ileus after open surgery for perforated appendicitis
Measured: From end of surgery till first passage of flatus or bowel opening, whichever comes first, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start9 Sep 2020
- Primary completion11 Mar 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Perforated AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised double-blind placebo-controlled parallel-group study. This is a superiority study assessing the effectiveness of the intervention
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Queen Elizabeth, Malaysia
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, Malaysia
- Responsible party
- Sponsor
- Investigators
- Hari Sellappan, MB BCh BAO, Principal investigator, Hospital Queen Elizabeth, Kota Kinabalu, Sabah, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512196
- Sponsor's protocol ID
- NMRR-ID-16-2905-30891
- Acronym
- PLaSSo
- Status last verified
- May 2022
- First submitted
- 6 May 2020
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Norman G, Atkinson RA, Smith TA, Rowlands C, Rithalia AD, Crosbie EJ, Dumville JC. Intracavity lavage and wound irrigation for prevention of surgical site infection. Cochrane Database Syst Rev. 2017 Oct 30;10(10):CD012234. doi: 10.1002/14651858.CD012234.pub2.
PubMed 29083473Kubota A, Goda T, Tsuru T, Yonekura T, Yagi M, Kawahara H, Yoneda A, Tazuke Y, Tani G, Ishii T, Umeda S, Hirano K. Efficacy and safety of strong acid electrolyzed water for peritoneal lavage to prevent surgical site infection in patients with perforated appendicitis. Surg Today. 2015 Jul;45(7):876-9. doi: 10.1007/s00595-014-1050-x. Epub 2014 Nov 13.
PubMed 25387655Sellappan H, Alagoo D, Loo C, Vijian K, Sibin R, Chuah JA. Effect of peritoneal and wound lavage with super-oxidized solution on surgical-site infection after open appendicectomy in perforated appendicitis (PLaSSo): randomized clinical trial. BJS Open. 2024 Sep 3;8(5):zrae121. doi: 10.1093/bjsopen/zrae121.
PubMed 39413050
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Surgical Site Infection in Perforated Appendicitis After Peritoneal Lavage With Super-oxidised Solution: A Randomised Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04512196
- Acronym / sponsor ID
- PLaSSo / NMRR-ID-16-2905-30891
- Conditions
- Perforated Appendicitis
- Keywords
- Perforated Appendicitis, Super-oxidised solution, Surgical site infection, Peritoneal lavage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hospital Queen Elizabeth, MalaysiaOther government
- Collaborators
- Ministry of Health, Malaysia
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised double-blind placebo-controlled parallel-group study. This is a superiority study assessing the effectiveness of the intervention
| Arm | Type | Receives |
|---|---|---|
| Super-oxidised Solution | Experimental | Drug: Superoxidized WaterPeritoneal lavage with super-oxidised solution of at least 10 cc/kg and wound lavage with super-oxidised solution 1 cc/kg |
| Normal Saline | Placebo comparator | Drug: Normal SalinePeritoneal lavage with normal saline 0.9% of at least 10 cc/kg and wound lavage with normal saline 0.9% 1 cc/kg |
Who may qualify
- Ages
- 13 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between the age 13 and 70 years
- Diagnosed with perforated appendicitis intra-operatively
- Undergo open appendicectomy via Lanz incision
Key exclusion criteria (2 listed)
- Surgical technique: Laparoscopic appendicectomy or mid-line laparotomy
- Patients on steroid treatment and immunosuppressant therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Superoxidized WaterAlso: Hydrocyn Aqua® (Vigilenz MD., Penang, Malaysia); FDA 510(K) Number: K142775Super-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. | Drug | Super-oxidised Solution |
| Normal SalineNormal saline contains 0.9% sodium chloride. | Drug | Normal Saline |
Primary outcome
Surgical site infection
Time frame: 30 days post surgery
Number of participants with surgical site infection after open surgery for perforated appendicitis
2 secondary outcomes
Inflammatory marker C-reactive protein
Time frame: 24 and 48 hours post surgery
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Background: PubMed 29083473Norman G, Atkinson RA, Smith TA, Rowlands C, Rithalia AD, Crosbie EJ, Dumville JC. Intracavity lavage and wound irrigation for prevention of surgical site infection. Cochrane Database Syst Rev. 2017 Oct 30;10(10):CD012234. doi: 10.1002/14651858.CD012234.pub2.
- Background: PubMed 25387655Kubota A, Goda T, Tsuru T, Yonekura T, Yagi M, Kawahara H, Yoneda A, Tazuke Y, Tani G, Ishii T, Umeda S, Hirano K. Efficacy and safety of strong acid electrolyzed water for peritoneal lavage to prevent surgical site infection in patients with perforated appendicitis. Surg Today. 2015 Jul;45(7):876-9. doi: 10.1007/s00595-014-1050-x. Epub 2014 Nov 13.
- Derived from this study: PubMed 39413050Sellappan H, Alagoo D, Loo C, Vijian K, Sibin R, Chuah JA. Effect of peritoneal and wound lavage with super-oxidized solution on surgical-site infection after open appendicectomy in perforated appendicitis (PLaSSo): randomized clinical trial. BJS Open. 2024 Sep 3;8(5):zrae121. doi: 10.1093/bjsopen/zrae121.
- Individual participant dataSharing planned: No
Related trials for Perforated Appendicitis
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Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
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Perforated Appendicitis and Postoperative Antibiotics Pilot Trial
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Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients With Diffuse Peritonitis
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Perforated Appendicitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hari Sellappan, MB BCh BAO principal investigator
Hospital Queen Elizabeth, Kota Kinabalu, Sabah, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superoxidized Water and Normal Saline in people with Perforated Appendicitis, run by Hospital Queen Elizabeth, Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (time frame: 30 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04512196, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.