Efficacy of Prophylactic Negative Pressure Wound Therapy (NPWT)

NCT05727995 | Unknown DMC

• 1 other identifier: 126/int/2019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound of Skin

Keywords

negative pressure wound therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• General in hospital complications

  Follow-up 15 days

• Days of acute hospitalization

  Follow-up 30 days

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Interventions

PICO7 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.

Experimental group

usual care dressing OTHER

usual care dressing

Control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician generates the random list and the outcome assessors guarantee the blinding procedure.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: After checking the patients' eligibility they will be blindly randomized in the arm allocation (allocation 1:1).

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 14, 2023
• Study Start: July 25, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)