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The Use of Wound Protector in Whipple's Procedure With Intrabiliary Stent

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01836237
Recruitment Status : Completed
First Posted : April 19, 2013
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Chad G. Ball, University of Calgary

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.


Condition or disease Intervention/treatment Phase
Surgical Wound Infection Pancreatic Neoplasms Device: Alexis - a wound protector Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Use of Wound Protectors to Prevent Surgical Site Infection for Whipples (Pancreatoduodenectomy) With Intrabiliary Stents: A Randomized Controlled Trial.
Actual Study Start Date : February 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Alexis group
In experimental group patients, the surgeon will use Alexis - a wound protector during surgery.
Device: Alexis - a wound protector
Alexis is a double ring, self-retaining circumferential device that is designed to protect incision site during surgical manipulation.

No Intervention: Control group
In no intervention group patients, the surgeon will not use any wound protector during surgery.



Primary Outcome Measures :
  1. Surgical Site Infection (SSI) Rate [ Time Frame: 1 month ]
    SSI will be evaluated on a daily basis by residents, the research/clinical fellow and/or Hepato-Pancreatico-Biliary Team by visual inspection of each wound.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, 18 years or older, undergoing pancreatoduodenectomy with intrabiliary stents in place at Foothills Medical centre, Calgary, Alberta.

Exclusion Criteria:

  • Patients will be excluded if they have had long-term steroid use or are unable to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836237


Locations
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Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N2T9
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Chad G. Ball, MD University of Calgary, Calgary, Alberta, Canada.

Publications:
Lee P, Waxman K, Taylor B et al. Use of wound-protection system and postoperative wound-infection rates in open appendectomy. Arch Surg 2009; 144:872-875.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Chad G. Ball, Assistant Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT01836237    
Other Study ID Numbers: E - 24807
First Posted: April 19, 2013    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Keywords provided by Dr. Chad G. Ball, University of Calgary:
Surgical site infection rate
Wound protector use
Whipple
Additional relevant MeSH terms:
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Infection
Surgical Wound Infection
Wound Infection
Pancreatic Neoplasms
Surgical Wound
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases