Impact of Surgical Site Infection in Peritonitis After Peritoneal Lavage With Super-oxidixed Solution

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13+
SponsorUniversiti Sains Malaysia

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients age 13yrs and above

Diagnosed with perforated viscus intraoperatively

Undergo Midline Laparotomy

ASA 3 and below

Disqualifiers

Surgical technique: Laparoscopic washouts

Patients on steroid treatment and immunosuppressant therapy.

More than ASA 3

Inability to give/understand informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 Saline

    Device

    aqueous solution of electrolytes and other hydrophilic molecules

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: Control groupPlacebo comparator 1 intervention
Group B: Study groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
30 days

Secondary outcomes

1

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

Time frame
24-48 hrs
2

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.

Time frame
1-2 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universiti Sains Malaysia

Lead sponsor

Hospital Queen Elizabeth, Malaysia

Collaborator

This trial is not recruiting at the moment. You can still explore other options: