Ignite Creation Date:
2024-05-06 @ 1:32 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01836237
Status:
COMPLETED
Last Update Posted:
2017-10-26
First Post:
2013-04-16
Brief Title:
The Use of Wound Protector in Whipples Procedure With Intrabiliary Stent
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
The Use of Wound Protectors to Prevent Surgical Site Infection for Whipples Pancreatoduodenectomy With Intrabiliary Stents A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2017-10
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:
None
Brief Summary:
Background There are no published studies regarding the use of wound protectors in the context of surgical site infection SSI rates among patients receiving a pancreatoduodenectomy Whipple with preoperatively placed intrabiliary stents In high volume experiences the SSI rate is 40-50 within this cohort In Calgary preoperative biliary stent placement for bile duct decompression represents the norm given typical surgical wait times In addition to having higher associated lengths of hospital stay ICU admissions hospital re-admissions and overall mortality patients with SSI are also delayed and often omitted in their progression to critical oncologic adjuvant chemotherapy As a result SSI remain crucial and devastating complications for pancreas surgeons and their patients alike
Methods The investigators will complete a randomized controlled trial evaluating the rate of SSI in adult patients who undergo a pancreatoduodenectomy following biliary stent placement when wound protectors are employed versus no wound protector use This trial will employ block randomization All four University of Calgary Heapato-Pancreatico-Biliary HPB surgeons will participate with a planned inclusion of all patients scheduled to undergo a pancreatoduodenectomy
Analysis The investigators will use an intention to treat approach to the analysis Categorical baseline data will be analyzed using the Fisher exact probability test Non-categorical baseline data will be analyzed using the Student t test SSI rates will be determined using the Fisher exact probability test
Hypothesis Wound protectors will reduce the SSI rate in patients undergoing a pancreatoduodenectomy with preoperatively placed intrabiliary stents
Potential Impact Given the tremendous oncologic economic and psychological impact of SSI following pancreatoduodenectomy the epidemic incidence of this complication must be reduced The additional crippling effect of refusing Medicare payment for any patient who receives a SSI in the United States has launched all techniques and analyses that can potentially reduce this complication into the National health care agenda In Canada health care utilization and economics are always a relevant and ever expanding area of importance It is crucial that the investigators reduce complications such as SSI regardless of individual payer sources
Methods The investigators will complete a randomized controlled trial evaluating the rate of SSI in adult patients who undergo a pancreatoduodenectomy following biliary stent placement when wound protectors are employed versus no wound protector use This trial will employ block randomization All four University of Calgary Heapato-Pancreatico-Biliary HPB surgeons will participate with a planned inclusion of all patients scheduled to undergo a pancreatoduodenectomy
Analysis The investigators will use an intention to treat approach to the analysis Categorical baseline data will be analyzed using the Fisher exact probability test Non-categorical baseline data will be analyzed using the Student t test SSI rates will be determined using the Fisher exact probability test
Hypothesis Wound protectors will reduce the SSI rate in patients undergoing a pancreatoduodenectomy with preoperatively placed intrabiliary stents
Potential Impact Given the tremendous oncologic economic and psychological impact of SSI following pancreatoduodenectomy the epidemic incidence of this complication must be reduced The additional crippling effect of refusing Medicare payment for any patient who receives a SSI in the United States has launched all techniques and analyses that can potentially reduce this complication into the National health care agenda In Canada health care utilization and economics are always a relevant and ever expanding area of importance It is crucial that the investigators reduce complications such as SSI regardless of individual payer sources
Detailed Description:
Introduction
The Department of Surgery at the University of Calgary has a long and proud tradition of research surrounding surgical site infections SSI More specifically former surgeon and Department Chair Dr Peter Cruse prospectively studied 23649 surgical wounds following operative intervention This massive study remains unmatched in size by a single institution publication Dr Cruse and Ms Rosemary Foord demonstrated a decrease in SSI rates with the pre-surgical use of hexachlorophene wash and by not shaving the surgical site1 They observed an increase in SSI rates with advanced age use of drains prolonged hospital stay before the operation and longer operative times Dr Cruse is directly responsible for confirming the validity of the wound classification system currently in use throughout the world clean clean-contaminated contaminated and dirty We propose to carry on the tradition of this line of investigation reinforcing Calgary as a world leader in SSI research
SSI are a frequent and costly source of post-operative morbidity They are the most common complication following gastrointestinal and biliary tract surgery occurring in 5-30 of patients SSI are associated with a two-fold increased risk of in-hospital mortality a 50 increase in intensive care admission a 6-day mean increase in hospital stay and a five-fold increased rate of readmission SSI also have additional and highly negative consequences in the treatment of oncology patients More specifically medical oncologists wait until all operative wounds are entirely healed prior to beginning adjuvant chemotherapy This delay is both oncologically concerning as well as psychologically destructive to highly stressed patients with poor associated survivals Furthermore with a significant SSI this delay often leads to a total omission of adjuvant therapies as a whole The estimated increased cost per SSI ranges from 1300 to 5000 in the United States In Canada a 1998 study estimated 3937 per infection resulting from increased hospital stay as well as emergency department and clinic visits The implications of these costs have now become paramount given that both US Medicare and Medicaid currently deny any reimbursement for patients who obtain an SSI while admitted to hospital In addition patients who develop SSI experience psychosocial distress loss of income and loss of productivity Prevention of SSI is therefore a vitally important goal in delivering quality care to patients The SSI rate is 40-50 in patients undergoing pancreatoduodenectomy with intrabiliary stents the population of interest for this study
Wound protectors are devices designed to protect the abdominal wound tissue edges from contamination and trauma during laparotomy A major reason for their conception and use is a theoretical reduction in risk of SSI Various devices with similar intent have been described since the 1960s falling into two main design categories 1 Those with an internal and external ring connected by impervious plastic and 2 Those with a single internal ring connected to a drape which extends outward over the wound edges and onto the abdomen where they are affixed with adhesive or clipsA recent meta-analysis of randomized controlled trials was conducted by a team led by the Principal Investigator to evaluate whether impervious plastic wound protectors reduce the risk of surgical site infection following gastrointestinal and biliary surgery Six studies representing 1008 patients were included Wound protectors were associated with a 45 decrease in SSI p 004 The Alexis Wound Protector a ring based model had evidence of superiority to other products and has been selected for this study based on this finding
Methods
Recruitment Contact information for study candidates will be obtained by the projects research fellow from the offices of the participating 4 surgeons Patients will be contacted prior to their surgery by the research fellow and will be provided information regarding the study Patients who consent to participate will be randomized
Randomization process This study is a simple two-arm randomized clinical trial RCT with block randomization Allocation will be concealed before the patient enters study Patients will be randomized by the Research fellow following consent Allocation will be provided to surgeon in a sealed envelope to be opened immediately before surgery Patients and the data analyst will be blind to allocation the surgeons cannot be blinded Charts will be blinded for data abstraction
Data collection Information will be collected by chart review from the operative report and patient records by the research fellow in the Department of Surgery
Data elements to be collected include
Date of birth Sex American Society of Anesthesiologist ASA score Surgeon Site if more than one facility Fellowresidentclerk present yn Surgical procedure Antibiotic prophylaxis received yn and time given Information about repeat antibiotic prophylaxis for longer surgeries Antibiotic typecombination Type of wound protector and manufacturer Prep type ETOH based chlorhexidine based iodine based Hair removal Medications given Packing Drains Wound classification Wound closure technique dressing type Length of surgery Surgical suite infection control factors eg UV OR ventilation if these differ Transfusions
Patient records
Current use of corticosteroidsimmune suppressant Preoperative chemotherapy Smoking history Co-morbidities diabetes hypertension etc Body Mass Index BMI
The presence of an SSI will be determined according to guidelines developed by the Centers for Disease Control More specifically SSI is defined as being the presence of at least one of the following
1 Purulent drainage with or without laboratory conformation from the superficial incision
2 Organisms isolated from an aseptically obtained culture of fluid from the superficial incision
3 At least one of the following signs or symptoms of infection
pain or tenderness localized swelling redness and superficial incision is deliberately opened by surgeon unless incision is culture-negative
4 Diagnosis of superficial incisional SSI by the surgeon or attending physician
Analysis
We will use an intention to treat approach to the analysis to avoid the effects of crossover and dropout To achieve a power superiority trial of 90 and alpha of 005 with a 5 crossover and a 40 expected SSI rate in control versus 10 in wound protector groups the total sample size is 78 ie 39 in each arm
Resources
This project will capitalize on an existing research team who can work collaboratively with the Principal Investigator and research assistant to carry out the project effectively and efficiently The current research team includes a clinical research fellow with experience recruiting research participants from this patient population and a project manager who can assist with ethics applications manuscript writing and reporting Additionally the Principal Investigator will benefit from mentorship by an experienced investigator who can provide guidance not only on methodology interpretation of data and publication strategies but also on the day-to-day logistics of running a research project
The Department of Surgery at the University of Calgary has a long and proud tradition of research surrounding surgical site infections SSI More specifically former surgeon and Department Chair Dr Peter Cruse prospectively studied 23649 surgical wounds following operative intervention This massive study remains unmatched in size by a single institution publication Dr Cruse and Ms Rosemary Foord demonstrated a decrease in SSI rates with the pre-surgical use of hexachlorophene wash and by not shaving the surgical site1 They observed an increase in SSI rates with advanced age use of drains prolonged hospital stay before the operation and longer operative times Dr Cruse is directly responsible for confirming the validity of the wound classification system currently in use throughout the world clean clean-contaminated contaminated and dirty We propose to carry on the tradition of this line of investigation reinforcing Calgary as a world leader in SSI research
SSI are a frequent and costly source of post-operative morbidity They are the most common complication following gastrointestinal and biliary tract surgery occurring in 5-30 of patients SSI are associated with a two-fold increased risk of in-hospital mortality a 50 increase in intensive care admission a 6-day mean increase in hospital stay and a five-fold increased rate of readmission SSI also have additional and highly negative consequences in the treatment of oncology patients More specifically medical oncologists wait until all operative wounds are entirely healed prior to beginning adjuvant chemotherapy This delay is both oncologically concerning as well as psychologically destructive to highly stressed patients with poor associated survivals Furthermore with a significant SSI this delay often leads to a total omission of adjuvant therapies as a whole The estimated increased cost per SSI ranges from 1300 to 5000 in the United States In Canada a 1998 study estimated 3937 per infection resulting from increased hospital stay as well as emergency department and clinic visits The implications of these costs have now become paramount given that both US Medicare and Medicaid currently deny any reimbursement for patients who obtain an SSI while admitted to hospital In addition patients who develop SSI experience psychosocial distress loss of income and loss of productivity Prevention of SSI is therefore a vitally important goal in delivering quality care to patients The SSI rate is 40-50 in patients undergoing pancreatoduodenectomy with intrabiliary stents the population of interest for this study
Wound protectors are devices designed to protect the abdominal wound tissue edges from contamination and trauma during laparotomy A major reason for their conception and use is a theoretical reduction in risk of SSI Various devices with similar intent have been described since the 1960s falling into two main design categories 1 Those with an internal and external ring connected by impervious plastic and 2 Those with a single internal ring connected to a drape which extends outward over the wound edges and onto the abdomen where they are affixed with adhesive or clipsA recent meta-analysis of randomized controlled trials was conducted by a team led by the Principal Investigator to evaluate whether impervious plastic wound protectors reduce the risk of surgical site infection following gastrointestinal and biliary surgery Six studies representing 1008 patients were included Wound protectors were associated with a 45 decrease in SSI p 004 The Alexis Wound Protector a ring based model had evidence of superiority to other products and has been selected for this study based on this finding
Methods
Recruitment Contact information for study candidates will be obtained by the projects research fellow from the offices of the participating 4 surgeons Patients will be contacted prior to their surgery by the research fellow and will be provided information regarding the study Patients who consent to participate will be randomized
Randomization process This study is a simple two-arm randomized clinical trial RCT with block randomization Allocation will be concealed before the patient enters study Patients will be randomized by the Research fellow following consent Allocation will be provided to surgeon in a sealed envelope to be opened immediately before surgery Patients and the data analyst will be blind to allocation the surgeons cannot be blinded Charts will be blinded for data abstraction
Data collection Information will be collected by chart review from the operative report and patient records by the research fellow in the Department of Surgery
Data elements to be collected include
Date of birth Sex American Society of Anesthesiologist ASA score Surgeon Site if more than one facility Fellowresidentclerk present yn Surgical procedure Antibiotic prophylaxis received yn and time given Information about repeat antibiotic prophylaxis for longer surgeries Antibiotic typecombination Type of wound protector and manufacturer Prep type ETOH based chlorhexidine based iodine based Hair removal Medications given Packing Drains Wound classification Wound closure technique dressing type Length of surgery Surgical suite infection control factors eg UV OR ventilation if these differ Transfusions
Patient records
Current use of corticosteroidsimmune suppressant Preoperative chemotherapy Smoking history Co-morbidities diabetes hypertension etc Body Mass Index BMI
The presence of an SSI will be determined according to guidelines developed by the Centers for Disease Control More specifically SSI is defined as being the presence of at least one of the following
1 Purulent drainage with or without laboratory conformation from the superficial incision
2 Organisms isolated from an aseptically obtained culture of fluid from the superficial incision
3 At least one of the following signs or symptoms of infection
pain or tenderness localized swelling redness and superficial incision is deliberately opened by surgeon unless incision is culture-negative
4 Diagnosis of superficial incisional SSI by the surgeon or attending physician
Analysis
We will use an intention to treat approach to the analysis to avoid the effects of crossover and dropout To achieve a power superiority trial of 90 and alpha of 005 with a 5 crossover and a 40 expected SSI rate in control versus 10 in wound protector groups the total sample size is 78 ie 39 in each arm
Resources
This project will capitalize on an existing research team who can work collaboratively with the Principal Investigator and research assistant to carry out the project effectively and efficiently The current research team includes a clinical research fellow with experience recruiting research participants from this patient population and a project manager who can assist with ethics applications manuscript writing and reporting Additionally the Principal Investigator will benefit from mentorship by an experienced investigator who can provide guidance not only on methodology interpretation of data and publication strategies but also on the day-to-day logistics of running a research project
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None