Efficacy of Prophylactic Negative Pressure Wound Therapy (NPWT)

Not Applicable

Recruiting

• Conditions: Wound of Skin
• Interventions: Other: usual care dressing; Device: PICO7

• Registration Number: NCT05727995
• Lead Sponsor: IRCCS Policlinico S. Donato

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.

Study Timeline

• Study Start: 2019-07-25
• Status Verified: 2023-02
• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-02-13
• Last Update Submitted: 2023-02-13
• Study First Posted: 2023-02-14
• Last Update Posted: 2023-02-14
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Control group	usual care dressing	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.
Experimental group	PICO7	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.

Primary Outcome Measures

Name	Time	Method
Leg wound assessment	At one month post-surgery	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IRCCS Policlinico San Donato; 🇮🇹 San Donato Milanese, MI, Italy