Surgical Site InfectionPlasso 2NCT06400394
Impact of Surgical Site Infection in Peritonitis After Peritoneal Lavage With Super-oxidixed Solution
A study testing Hydrocyn Aqua® and Normal Saline in people with Surgical Site Infection, run by Universiti Sains Malaysia.
Trial summary
This is randomised double blinded placebo-controlled parallel-group study. Patients in Hospital Queen Elizabeth, Sabah and Hospital Universiti Sains Malaysia, Kelantan who undergo laparotomy for peritonitis will be equally randomised into two groups : intervention group receiving super-oxidised solution and the… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Hydrocyn Aqua® and Normal Saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 May 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients age 13yrs and above
- Diagnosed with perforated viscus intraoperatively
- Undergo Midline Laparotomy
- ASA 3 and below
Who cannot join
- Surgical technique: Laparoscopic washouts
- Patients on steroid treatment and immunosuppressant therapy.
- More than ASA 3
- Inability to give/understand informed consent
- Revision-surgery (previous abdominal surgery within the last 30 days)
- Planned re-laparotomy within 30 days
- Terminal kidney failure requiring dialysis
- Concurrent abdominal wall infections
About this study
Official title: Impact of Surgical Site Infection in Peritonitis After Peritoneal Lavage With Super-oxidixed Solution: A Randomised Double-Blind, Placebo-controlled Trial
This is randomised double blinded placebo-controlled parallel-group study. Patients in Hospital Queen Elizabeth, Sabah and Hospital Universiti Sains Malaysia, Kelantan who undergo laparotomy for peritonitis will be equally randomised into two groups : intervention group receiving super-oxidised solution and the control group receiving normal saline during peritoneal and wound lavage.
This is a superiority study assessing the effectiveness of the intervention. The patient and doctors directly involved in the partient care will be blinded in this study
Read the detailed description
OBJECTIVES
PrimaryOutcome:
To evaluate the effectiveness of peritoneal lavage with superoxidised solution in reducing incidence of surgical site infection after open surgery for peritonitis.
SecondaryOutcome:
i.To evaluate the effectiveness of peritoneal lavage with super-oxidised solution in reducing inflammatory markers C-reactive protein(CRP) at 24 and 48 hours after open surgery for peritonitis ii.To evaluate the effectiveness of peritoneal lavage with super oxidised solution in reducing duration of post-operative ileus after open surgery for peritonitis.
METHODOLOGY
Study Design This is a randomised double blind placebo controlled parallel group study. This is a superiority study assessing the effectiveness of the intervention. The patients and doctors directly involved in the patient care will be blinded in this study.
Masking Study participants were randomly assigned following computerized block randomization using the website www.randomization.com with a block size of 8 and allocation ratio of 1:1. Allocation sequence and concealment will be performed by the research staff from the Clinical Research Centre who had no clinical involvement in the trial. The allocation sequence will be concealed from the researcher enrolling and assessing the participants in sequentially numbered, opaque, sealed envelopes.
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.
2 arms with 56 participants per arm Study group: Peritoneal lavage with super-oxidised solution of at least 1L and wound lavage with super-oxidised solution of 500ml [Super-oxidised solution used in this study is Hydrocyn Aqua® (Vigilenz MD., Penang, Malaysia)] Control group: Peritoneal lavage with normal saline 0.9% 1L and wound lavage with normal saline 0.9% 500ml
Enrollment The estimated total number of participants to be enrolled is about 116 with 20% dropout rate
- Conditions
- Surgical Site Infection
- Being tested
- Hydrocyn Aqua®, Normal Saline
- Keywords
- "Peritonitis" "Peritoneal lavage" "surgical site infection" "super-oxidised solution"
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocyn Aqua®Device
The study solution comes in a liquid form containing hypochlorous acid (HOCl) in a concentration of 0.003%. It is used as a topical agent for wound and peritoneal lavage before wound closure
Normal SalineDevice
aqueous solution of electrolytes and other hydrophilic molecules
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Peritoneal lavage with normal saline 0.9% 1L and wound lavage with normal saline 0.9% 500ml Receives: Device: Normal Saline |
| Study group | Experimental | Peritoneal lavage with super-oxidised solution of at least 1L and wound lavage with super-oxidised solution of 500ml Receives: Device: Hydrocyn Aqua® |
What is being measured
The primary outcome is the main question the study is designed to answer.
SSI Incidence
To evaluate the effectiveness of peritoneal lavage with superoxidised solution in reducing incidence of surgical site infection after open surgery for perforated viscus.
Measured: 30 days
Secondary outcomes (2)
CRP Level
To evaluate the effectiveness of peritoneal lavage with super-oxidised solution in reducing inflammatory markers C-reactive protein(CRP) at 24 and 48 hours after open surgery for perforated viscus
Measured: 24-48 hrs
Flatus time
To evaluate the effectiveness of peritoneal lavage with super oxidised solution in reducing duration of post-operative ileus after open surgery for perforated viscus.
Measured: 1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies 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
- a randomised double blind placebo controlled parallel group study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Queen Elizabeth, Malaysia
- Responsible party
- Principal investigator, Dinesh Alagoo, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400394
- Sponsor's protocol ID
- RSCH ID-24-01241-VGD
- Acronym
- Plasso 2
- Status last verified
- Aug 2024
- First submitted
- 1 May 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Surgical Site Infection in Peritonitis After Peritoneal Lavage With Super-oxidixed Solution: A Randomised Double-Blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06400394
- Acronym / sponsor ID
- Plasso 2 / RSCH ID-24-01241-VGD
- Conditions
- Surgical Site Infection
- Keywords
- "Peritonitis" "Peritoneal lavage" "surgical site infection" "super-oxidised solution"
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- Hospital Queen Elizabeth, Malaysia
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 6 May 2024 (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 is randomised double blinded placebo-controlled parallel-group study. Patients in Hospital Queen Elizabeth, Sabah and Hospital Universiti Sains Malaysia, Kelantan who undergo laparotomy for peritonitis will be equally randomised into two groups : intervention group receiving super-oxidised solution and the control group receiving normal saline during peritoneal and wound lavage.
This is a superiority study assessing the effectiveness of the intervention. The patient and doctors directly involved in the partient care will be blinded in this study
Detailed description
OBJECTIVES
PrimaryOutcome:
To evaluate the effectiveness of peritoneal lavage with superoxidised solution in reducing incidence of surgical site infection after open surgery for peritonitis.
SecondaryOutcome:
i.To evaluate the effectiveness of peritoneal lavage with super-oxidised solution in reducing inflammatory markers C-reactive protein(CRP) at 24 and 48 hours after open surgery for peritonitis ii.To evaluate the effectiveness of peritoneal lavage with super oxidised solution in reducing duration of post-operative ileus after open surgery for peritonitis.
METHODOLOGY
Study Design This is a randomised double blind placebo controlled parallel group study. This is a superiority study assessing the effectiveness of the intervention. The patients and doctors directly involved in the patient care will be blinded in this study.
Masking Study participants were randomly assigned following computerized block randomization using the website www.randomization.com with a block size of 8 and allocation ratio of 1:1. Allocation sequence and concealment will be performed by the research staff from the Clinical Research Centre who had no clinical involvement in the trial. The allocation sequence will be concealed from the researcher enrolling and assessing the participants in sequentially numbered, opaque, sealed envelopes.
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.
2 arms with 56 participants per arm Study group: Peritoneal lavage with super-oxidised solution of at least 1L and wound lavage with super-oxidised solution of 500ml [Super-oxidised solution used in this study is Hydrocyn Aqua® (Vigilenz MD., Penang, Malaysia)] Control group: Peritoneal lavage with normal saline 0.9% 1L and wound lavage with normal saline 0.9% 500ml
Enrollment The estimated total number of participants to be enrolled is about 116 with 20% dropout rate
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
- a randomised double blind placebo controlled parallel group study
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Device: Normal SalinePeritoneal lavage with normal saline 0.9% 1L and wound lavage with normal saline 0.9% 500ml |
| Study group | Experimental | Device: Hydrocyn Aqua®Peritoneal lavage with super-oxidised solution of at least 1L and wound lavage with super-oxidised solution of 500ml |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients age 13yrs and above
- Diagnosed with perforated viscus intraoperatively
- Undergo Midline Laparotomy
- ASA 3 and below
Key exclusion criteria (8 listed)
- Surgical technique: Laparoscopic washouts
- Patients on steroid treatment and immunosuppressant therapy.
- More than ASA 3
- Inability to give/understand informed consent
- Revision-surgery (previous abdominal surgery within the last 30 days)
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 |
|---|---|---|
| Hydrocyn Aqua®The study solution comes in a liquid form containing hypochlorous acid (HOCl) in a concentration of 0.003%. It is used as a topical agent for wound and peritoneal lavage before wound closure | Device | Study group |
| Normal Salineaqueous solution of electrolytes and other hydrophilic molecules | Device | Control group |
Primary outcome
SSI Incidence
Time frame: 30 days
To evaluate the effectiveness of peritoneal lavage with superoxidised solution in reducing incidence of surgical site infection after open surgery for perforated viscus.
2 secondary outcomes
CRP Level
Time frame: 24-48 hrs
Flatus time
Time frame: 1-2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocyn Aqua® and Normal Saline in people with Surgical Site Infection, run by Universiti Sains 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
SSI Incidence (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.