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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Hydrocyn Aqua®
DeviceThe 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
Deviceaqueous solution of electrolytes and other hydrophilic molecules
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
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.
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: