Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400394
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-05-01
Brief Title:
Impact of Surgical Site Infection in Peritonitis After Peritoneal Lavage With Super-oxidixed Solution
Sponsor:
Universiti Sains Malaysia
Organization:
Universiti Sains Malaysia
Study Overview
Official Title:
Impact of Surgical Site Infection in Peritonitis After Peritoneal Lavage With Super-oxidixed Solution A Randomised Double-Blind Placebo-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Plasso 2
Brief 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 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
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
iTo evaluate the effectiveness of peritoneal lavage with super-oxidised solution in reducing inflammatory markers C-reactive proteinCRP at 24 and 48 hours after open surgery for peritonitis iiTo 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 wwwrandomizationcom with a block size of 8 and allocation ratio of 11 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 09 1L and wound lavage with normal saline 09 500ml
Enrollment The estimated total number of participants to be enrolled is about 116 with 20 dropout rate
PrimaryOutcome
To evaluate the effectiveness of peritoneal lavage with superoxidised solution in reducing incidence of surgical site infection after open surgery for peritonitis
SecondaryOutcome
iTo evaluate the effectiveness of peritoneal lavage with super-oxidised solution in reducing inflammatory markers C-reactive proteinCRP at 24 and 48 hours after open surgery for peritonitis iiTo 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 wwwrandomizationcom with a block size of 8 and allocation ratio of 11 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 09 1L and wound lavage with normal saline 09 500ml
Enrollment The estimated total number of participants to be enrolled is about 116 with 20 dropout rate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None