Wound Protector Dual-ring Alexis® in Pancreaticoduodenectomy (PALEXIS)
|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
|Condition or disease||Intervention/treatment||Phase|
|Surgical Site Infection||Device: Alexis Device: Standard 3M™ Steri-Drape 2||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||212 participants|
|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).|
|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|
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)
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.
- 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.
- 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.
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820648
|Verona, Italy, 37124|