Efficacy of Prophylactic Negative Pressure Wound Therapy (NPWT)

NCT ID: NCT05727995

Last Updated: 2023-02-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-25
• Study Completion Date: 2024-12-31

Brief Summary

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.

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.

Conditions

Wound of Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

PICO7

Intervention Type: DEVICE

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.

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.

Group Type: SHAM_COMPARATOR

usual care dressing

Intervention Type: OTHER

usual care dressing

Interventions

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.

Intervention Type: DEVICE

usual care dressing

usual care dressing

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Policlinico S. Donato

OTHER

Sponsor Role: lead

Responsible Party

Gianluca Castiello

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Policlinico San Donato

San Donato Milanese, MI, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Gianluca Castiello

Role: primary

gianluca.castiello@grupposandonato.it

3474834455

Other Identifiers

126/int/2019

Identifier Type: -

Identifier Source: org_study_id