Efficacy of Prophylactic Negative Pressure Wound Therapy (NPWT)

Study Overview
=================
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.

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

Conditions
-----------------
Wound of Skin

Intervention / Treatment
-----------------
* Device: PICO7
* Other: usual care dressing


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: After checking the patients' eligibility they will be blindly randomized in the arm allocation (allocation 1:1).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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<br>* 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.<br>|
| Sham Comparator: Control group<br>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<br>* usual care dressing<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
negative pressure wound therapy