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Wound Protector Dual-ring Alexis® in Pancreaticoduodenectomy (PALEXIS)

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: NCT03820648
Recruitment Status : Terminated (no differences between the groups at the interim analysis)
First Posted : January 29, 2019
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Azienda Ospedaliera Universitaria Integrata Verona

Brief Summary:
Surgical site infection (SSI) is a leading cause of preventable morbidity and mortality in North America and worldwide. This condition has consistently been reported to account for up to 25% of all healthcare-associated infections. In a cost analysis, SSIs post-pancreaticoduodenectomy (PD) dramatically increases the treatment costs. More importantly, postoperative wound infections delay postoperative adjuvant chemotherapy, which is indicated in the majority of patients undergoing PD for pancreatic cancer. Protective covers or 'wound protectors' are hypothesized to be an improvement over adhesive membrane barriers as they are believed to reduce intraoperative contamination while concomitantly preserving the temperature and humidity of the surgical wound. The aim of this study is to assess if the use of wound protector can reduce the wound infection rate in patients undergoing to PD.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Device: Alexis Device: Standard 3M™ Steri-Drape 2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study is an RCT, single-blinded, conducts in patients with cancer submitted to PD (1:1). In the experimental group, we will use the dual-ring WP Alexis (Applied Medical, Rancho Santa Margarita, California, USA), while in the control group we will use the standard 3M™ Steri-Drape 2. There is planned a clinical visit of follow-up on the 30th day from the operation day (as in clinical practice).
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Wound Protector Dual-ring Alexis® in Pancreaticoduodenectomy: a Randomized Single-blind Controlled Clinical Trial
Actual Study Start Date : September 7, 2017
Actual Primary Completion Date : December 9, 2019
Actual Study Completion Date : December 9, 2019

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Arm Intervention/treatment
Experimental: Alexis® device
In this group, we will be used WP dual-ring Alexis® (Figure 1). The Alexis® 's size will be decided on the basis of abdominal incision (Alexis® X-Large or Alexis® XX-Large will be used for 11-17cm or 17-25 cm incision length respectively)
Device: Alexis
The Alexis® (Applied Medical) is a surgical device indicated for use in retracting and protecting an incision during laparoscopic or open surgery. It is intended to allow the surgeon to access through an atraumatic circumferentially 360 degrees retracted wound that provides maximum exposure with minimum incision size. Further, once positioned, the Alexis Wound Retractor is intended to protect against wound contamination.The device will be manufactured in five sizes, extra-small, small, medium, medium-large and large. The Alexis Wound Retractor has been found non-toxic and non-irritant when tested in accordance with ISO 10993, Part 1: Biological Evaluation of Medical Devices. The materials used in the manufacturing of the Alexis Wound Retractor have been tested in accordance with applicable standards and was determined to pass tensile strength, elongation, (ASTM D 412) and Tear Strength (ASTM D 624). Functional performance testing has been completed and has passed the required testing.

Active Comparator: Standard 3M™ Steri-Drape 2
In this group, we will be used Standard 3M™ Steri-Drape 2
Device: Standard 3M™ Steri-Drape 2
Standard 3M™ Steri-Drape 2 is a standard drape applicated on the skin of the patient before the surgical incision.




Primary Outcome Measures :
  1. Surgical site infection [ Time Frame: 30th day postoperative ]
    Number of SSI onset in patients submitted to PD until the 30th day postoperative. This endpoint will be compared between the two groups.


Secondary Outcome Measures :
  1. Device resistance [ Time Frame: Intraoperative ]
    Number intraoperative device rupture in both groups. It will be also recorded the number of device lesions seen at the end of the surgical operation.

  2. Treatment costs related to increased hospital stays due to SSI [ Time Frame: 30th day postoperative ]
    Number of additional days to the average hospital stays (7 days) of the patients submitted to PD at our Institute, related to the onset of SSI until the 30th day postoperative

  3. Costs related to the use of additional antibiotics administered for the treatment of SSI [ Time Frame: 30th day postoperative ]
    Evaluation of the total costs of the additional antibiotic therapy administered for the treatment of SSI, developed within the 30th day postoperative, in the two patient groups. It will be considered like the ex-factory price of the drug.



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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:

  • Scheduled for elective PD
  • Age ≥ 18 years
  • Ability of the subject to understand character and individual consequences of the clinical trial
  • Written informed consent

Exclusion Criteria:

  • Under 18 years of age
  • Unable to sign 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): NCT03820648


Locations
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Italy
AOUI Verona
Verona, Italy, 37124
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Integrata Verona
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Azienda Ospedaliera Universitaria Integrata Verona
ClinicalTrials.gov Identifier: NCT03820648    
Other Study ID Numbers: CE 1369 cesc
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes