Ignite Creation Date:
2024-07-17 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465901
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-05-29
Brief Title:
A Stratified Multi-ARm muLti-site Randomised Platform Trial Aiming to Reduce the INcidence of Post-operative SSI
Sponsor:
University of Birmingham
Organization:
University of Birmingham
Study Overview
Official Title:
MARLIN Stratified Multi-arm Multi-stage Factorial Randomised Platform Trial Aiming to Reduce the Incidence of Post-operative Surgical Site Infection SSI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
MARLIN
Brief Summary:
MARLIN is a stratified multi-arm multi-stage factorial randomised platform trial aiming to reduce the incidence of post-operative surgical site infection SSI
Detailed Description:
MARLINs primary objective is assess whether different interventions used at three different time points during the participants operative care pre- intra- and post-operatively can reduce SSI at 30 days in patients undergoing abdominal surgery MARLIN will assess the clinical effectiveness in both clean-contaminated wounds and contaminated or dirty wounds and will assess the interventions being assessed individually and in combination
Patients adults and children undergoing surgery with abdominal incision of at least 5cm with an anticipated clean-contaminated or contaminated or dirty wound undergoing emergency or elective and open or laparoscopic surgery are eligible Participants will be recruited from hospitals within the National Institute for Health and Care Research Global Surgery Unit NIHR GSU network ie hospitals in Benin Rwanda Ghana India Mexico Nigeria South Africa
Interventions will be introduced at the preoperative window intra-operatively and postoperatively as it is not yet known which if any of these timed intervention periods are most effective It is planned that only one intervention will be introduced in each window This format will allow testing for interaction between interventions including cumulated benefit It will also enable unsuccessful interventions to be withdrawn and potentially substituted This is a pragmatic design and wherever possible standard care will be provided in the control arm
After patient eligibility has been confirmed and informed consent has been obtained patients will be randomised into the MARLIN trial by a member of the MARLIN research team at the site Randomisation will occur within 72 hours prior to the patients operation Patients will be randomised dependent on which arms are available at the randomising site and in which they consent to participate ie it is possible for patients to opt out of one or more of the intervention timepoints
Patients may be randomised to receive
Chlorhexidine Gluconate preoperative shower 20 - 40 eg hibiscrub or standard preoperative preparation
Topical wound wash before closure eg granudacyn or standard intraoperative preparation
Dialkylcarbamoyl chloride DACC wound dressing eg Leukomed sorbact or standard post-operative wound care
The randomisation ratio at each timepoint will be 11 between the intervention and control in the first instance although if and when multiple intervention arms are open the ratio may change with agreement of the data monitoring committee DMC with reduced randomisation into the control arm due to pooling Eligible participants will be randomised to receive some or all of the trial interventions sites will opt-in to each treatment depending on local deliverability which will be reflected in the randomisation system Randomisation will occur around the time of pre-operative assessment
Sample size
An internal pilot will be carried out for each intervention within the study For each pilot Internal pilots of 100 participants per intervention will be undertaken to assess deliverability safety compliance and participant acceptability Internal pilots will be undertaken in at least two countries for any given intervention to assess generalisability Interventions will then be made available across the wider Global Surgery network
For the clean-contaminated stratum the maximum sample size required for a 3-stage design with control SSI rate of 16 two-sided overall alpha of 0043 overall power of 086 and 20 relative reduction 32 absolute reduction with 5 lost to follow up would be 6006 participants for all 3 questions as a factorial design As the second and third treatment will start after the first stage interim analysis of the first intervention 7544 participants are required 8196 participants are required if the first intervention works and leads to lower SSI rate
For the contaminateddirty stratum the maximum sample size required for a 3-stage design with control SSI rate of 30 two-sided overall alpha of 0043 power of 086 and 30 relative reduction 9 absolute reduction with 10 lost to follow up would require 1342 participants for all 3 questions as a factorial design As the second and third treatment will start after first stage interim analysis of the first intervention 1596 are required participants 1896 participants are required if the first intervention works and leads to lower SSI rate
Multistage analysis
For the clean-contaminated group there will be two interim analyses the first after 1824 participants and the second at interim analysis at 3126 for each of the questions For the contaminateddirty group the first interim will happen at 372 participants and the second at 638 participants
Inclusion Criteria
Patients with at least one abdominal incision that is 5cm open or laparoscopic extraction site with an anticipated clean-contaminated contaminated or dirty surgical wound
Patients undergoing emergency surgery on an unplanned admission or elective surgery on a planned admission operations
Any operative indication for abdominal surgery excluding caesarean section see exclusion criteria
Patient able and willing to provide written informed consent signature or a fingerprint prior to surgery including emergency cases
Patients aged 5 years and over Each country will decide the lower and upper if applicable according to local regulations age limit for the trial This will be dependent on country-specific regulatory approvals Age eligibility will vary by country Patient Exclusion Criteria
Patient unable to complete post-operative follow-up ie will not be contactable after discharge
Patients undergoing clean surgical procedures
Patients adults and children undergoing surgery with abdominal incision of at least 5cm with an anticipated clean-contaminated or contaminated or dirty wound undergoing emergency or elective and open or laparoscopic surgery are eligible Participants will be recruited from hospitals within the National Institute for Health and Care Research Global Surgery Unit NIHR GSU network ie hospitals in Benin Rwanda Ghana India Mexico Nigeria South Africa
Interventions will be introduced at the preoperative window intra-operatively and postoperatively as it is not yet known which if any of these timed intervention periods are most effective It is planned that only one intervention will be introduced in each window This format will allow testing for interaction between interventions including cumulated benefit It will also enable unsuccessful interventions to be withdrawn and potentially substituted This is a pragmatic design and wherever possible standard care will be provided in the control arm
After patient eligibility has been confirmed and informed consent has been obtained patients will be randomised into the MARLIN trial by a member of the MARLIN research team at the site Randomisation will occur within 72 hours prior to the patients operation Patients will be randomised dependent on which arms are available at the randomising site and in which they consent to participate ie it is possible for patients to opt out of one or more of the intervention timepoints
Patients may be randomised to receive
Chlorhexidine Gluconate preoperative shower 20 - 40 eg hibiscrub or standard preoperative preparation
Topical wound wash before closure eg granudacyn or standard intraoperative preparation
Dialkylcarbamoyl chloride DACC wound dressing eg Leukomed sorbact or standard post-operative wound care
The randomisation ratio at each timepoint will be 11 between the intervention and control in the first instance although if and when multiple intervention arms are open the ratio may change with agreement of the data monitoring committee DMC with reduced randomisation into the control arm due to pooling Eligible participants will be randomised to receive some or all of the trial interventions sites will opt-in to each treatment depending on local deliverability which will be reflected in the randomisation system Randomisation will occur around the time of pre-operative assessment
Sample size
An internal pilot will be carried out for each intervention within the study For each pilot Internal pilots of 100 participants per intervention will be undertaken to assess deliverability safety compliance and participant acceptability Internal pilots will be undertaken in at least two countries for any given intervention to assess generalisability Interventions will then be made available across the wider Global Surgery network
For the clean-contaminated stratum the maximum sample size required for a 3-stage design with control SSI rate of 16 two-sided overall alpha of 0043 overall power of 086 and 20 relative reduction 32 absolute reduction with 5 lost to follow up would be 6006 participants for all 3 questions as a factorial design As the second and third treatment will start after the first stage interim analysis of the first intervention 7544 participants are required 8196 participants are required if the first intervention works and leads to lower SSI rate
For the contaminateddirty stratum the maximum sample size required for a 3-stage design with control SSI rate of 30 two-sided overall alpha of 0043 power of 086 and 30 relative reduction 9 absolute reduction with 10 lost to follow up would require 1342 participants for all 3 questions as a factorial design As the second and third treatment will start after first stage interim analysis of the first intervention 1596 are required participants 1896 participants are required if the first intervention works and leads to lower SSI rate
Multistage analysis
For the clean-contaminated group there will be two interim analyses the first after 1824 participants and the second at interim analysis at 3126 for each of the questions For the contaminateddirty group the first interim will happen at 372 participants and the second at 638 participants
Inclusion Criteria
Patients with at least one abdominal incision that is 5cm open or laparoscopic extraction site with an anticipated clean-contaminated contaminated or dirty surgical wound
Patients undergoing emergency surgery on an unplanned admission or elective surgery on a planned admission operations
Any operative indication for abdominal surgery excluding caesarean section see exclusion criteria
Patient able and willing to provide written informed consent signature or a fingerprint prior to surgery including emergency cases
Patients aged 5 years and over Each country will decide the lower and upper if applicable according to local regulations age limit for the trial This will be dependent on country-specific regulatory approvals Age eligibility will vary by country Patient Exclusion Criteria
Patient unable to complete post-operative follow-up ie will not be contactable after discharge
Patients undergoing clean surgical procedures
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?:
None
Is an FDA AA801 Violation?:
None