Efficacy of Prophylactic Negative Pressure Wound Therapy (NPWT) (EFESO)

Efficacy of Prophylactic Negative Pressure Wound Therapy (NPWT) on Prevention for Complications After Open Saphenous Vein Harvest in Cardiac Surgery (EFESO Protocol).

The role of prophylactic negative pressure wound therapy (NPWT) is promising in reducing wound-related complications. However, the prophylactic use of NPWT in reducing wound complications in patients who underwent conventional open harvesting of the great saphenous vein has been under-investigated compering with other surgical approaches.

Therefore, this study aims to assess the effect size of the prophylactic NPWT in preventing wound dehiscence in high-risk patients who underwent conventional open harvesting of the great saphenous vein as a conduit for coronary artery bypass.

Study Overview

• Status: Recruiting
• Conditions: Wound of Skin
• Intervention / Treatment: Device: PICO7; Other: usual care dressing

Detailed Description

The study design is a prospective, randomized, controlled, and monocentric trial. The primary endpoint is given by the reduction of wound dehiscence as a dichotomic outcome (yes versus no).

More precisely, in the experimental group, we will use the proposed device PICO7 (NPWT); this device is certificate CE. PICO consists of a single-use (i.e., completely disposable) NPWT unit, canister, and dressing that are designed for application over clean, closed, sutured, or stapled incisions in a simple peel-and-place process. Instead, in the control group, patients will receive standard care.

Finally, patients eligible to be enrolled in this study will be blindly randomized using for the arm allocation (allocation 1:1). Randomization should take place as soon as possible after consent. Patients will be randomized on a 1:1 basis to receive either dressing.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • San Donato Milanese, MI, Italy, 20097
      • Recruiting
      • IRCCS Policlinico San Donato
      • Contact: Gianluca Castiello; Phone Number: 3474834455; Email: gianluca.castiello@grupposandonato.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients (aged ≥ 50 years)
• Diagnosis of Diabetes (both type 1 and 2) as comorbidity with anamnesis during the last year of poor glycemic control (HbA1C >7.5%)
• BMI ≥ 25 Kg/m2

Exclusion Criteria:

• Cognitive impairment
• Anamnesis of non-heling wounds
• Wagner grade 2-5 foot wound
• Osteomyelitis
• Pregnancy
• Contraindication to use PICO7 described previously.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group; The dressing is a polyurethane film with acrylic adhesive that adheres the dressing to the skin surrounding the incision and a polyurethane shell that encapsulates the foam bolster and interface layer, providing a closed system. The PICO pump maintains negative pressure wound therapy (NPWT) at 80mmHg (nominal) +/- 20mmHg to the wound surface. Exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film. PICO is intended for use in wound sizes (surface area x depth) up to 400 cm3, which are considered to be low to moderately exuding. The kit is intended to be used for 7 days on low-exuding wounds and 6 days on moderately exuding wounds. The therapy duration of the kit may be less than indicated if a clinical practice or other factors, such as wound type, wound size, rate or volume of exudate, orientation of the dressing or environmental conditions, result in more frequent dressing changes.	Device: PICO7; The use of PICO is contraindicated in the presence of: Patients with malignancy in the wound bed or margins of the wound; Previously confirmed and untreated osteomyelitis; Nonenteric and unexplored fistulas; Necrotic tissue with eschar present; Exposed arteries, veins, nerves or organs; Exposed anastomotic sites; Emergency airway aspiration; Pleural, mediastinal or chest tube drainage; Surgical suction.
SHAM_COMPARATOR: Control group; Patients in the control arm will receive a usual care dressing using absorbent cotton pads placed in contact with the wound. Dressings will be applied directly to the wound surface to protect the wound surface environment and the wound bed. Dressing chances are scheduled every 48h.	Other: usual care dressing; usual care dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leg wound assessment	This outcome will be assessed as a categorial variable: a) no complication; b) dehiscence; c) signs of superficial infections. The operative assessment consists of a daily evaluation of the leg wound after the surgery and follow-up assessments.	At baseline (post-surgery)
Leg wound assessment	This outcome will be assessed as a categorial variable: a) no complication; b) dehiscence; c) signs of superficial infections. The operative assessment consists of a daily evaluation of the leg wound after the surgery and follow-up assessments.	At 15 days post-surgery
Leg wound assessment	This outcome will be assessed as a categorial variable: a) no complication; b) dehiscence; c) signs of superficial infections. The operative assessment consists of a daily evaluation of the leg wound after the surgery and follow-up assessments.	At one month post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General in hospital complications	General In-hospital clinical complications (yes versus no; if yes, which complications?)	Follow-up 15 days
Days of acute hospitalization	Length of hospital stay	Follow-up 30 days

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Donato

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 25, 2019
• Primary Completion (ANTICIPATED): December 1, 2024
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (ESTIMATE): February 14, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: negative pressure wound therapy
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 126/int/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No