Wound Protector Dual-ring Alexis® in Pancreaticoduodenectomy

NCT03820648 | Terminated

• 1 other identifier: CE 1369 cesc
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• Surgical site infection

  Number of SSI onset in patients submitted to PD until the 30th day postoperative. This endpoint will be compared between the two groups.

  30th day postoperative

Secondary Outcomes (3)

• Device resistance

  Intraoperative

• Treatment costs related to increased hospital stays due to SSI

  30th day postoperative

• Costs related to the use of additional antibiotics administered for the treatment of SSI

  30th day postoperative

Study Arms (2)

Alexis® device

EXPERIMENTAL

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

Standard 3M™ Steri-Drape 2

ACTIVE COMPARATOR

In this group, we will be used Standard 3M™ Steri-Drape 2

Device: Standard 3M™ Steri-Drape 2

Interventions

Alexis DEVICE

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.

Alexis® device

Standard 3M™ Steri-Drape 2 DEVICE

Standard 3M™ Steri-Drape 2 is a standard drape applicated on the skin of the patient before the surgical incision.

Standard 3M™ Steri-Drape 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Under 18 years of age
• Unable to sign informed consent

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

AOUI Verona

Verona, 37124, Italy

Location

Related Publications (1)

• De Pastena M, Marchegiani G, Paiella S, Fontana M, Esposito A, Casetti L, Secchettin E, Manzini G, Bassi C, Salvia R. Use of an intraoperative wound protector to prevent surgical-site infection after pancreatoduodenectomy: randomized clinical trial. Br J Surg. 2020 Aug;107(9):1107-1113. doi: 10.1002/bjs.11527. Epub 2020 Mar 12.

  PMID: 32162321 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: January 29, 2019
• Study Start: September 7, 2017
• Primary Completion: December 9, 2019
• Study Completion: December 9, 2019
• Last Updated: January 14, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)