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

Primary Purpose

Wound of Skin

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
PICO7
usual care dressing
Sponsored by
IRCCS Policlinico S. Donato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Wound of Skin focused on measuring negative pressure wound therapy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IRCCS Policlinico San DonatoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

General in hospital complications
General In-hospital clinical complications (yes versus no; if yes, which complications?)
Days of acute hospitalization
Length of hospital stay

Full Information

First Posted
February 2, 2023
Last Updated
February 13, 2023
Sponsor
IRCCS Policlinico S. Donato
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1. Study Identification

Unique Protocol Identification Number
NCT05727995
Brief Title
Efficacy of Prophylactic Negative Pressure Wound Therapy (NPWT)
Acronym
EFESO
Official Title
Efficacy of Prophylactic Negative Pressure Wound Therapy (NPWT) on Prevention for Complications After Open Saphenous Vein Harvest in Cardiac Surgery (EFESO Protocol).
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2019 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Donato

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound of Skin
Keywords
negative pressure wound therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
After checking the patients' eligibility they will be blindly randomized in the arm allocation (allocation 1:1).
Masking
Outcomes Assessor
Masking Description
The statistician generates the random list and the outcome assessors guarantee the blinding procedure.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
PICO7
Intervention Description
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
Other
Intervention Name(s)
usual care dressing
Intervention Description
usual care dressing
Primary Outcome Measure Information:
Title
Leg wound assessment
Description
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.
Time Frame
At baseline (post-surgery)
Title
Leg wound assessment
Description
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.
Time Frame
At 15 days post-surgery
Title
Leg wound assessment
Description
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.
Time Frame
At one month post-surgery
Secondary Outcome Measure Information:
Title
General in hospital complications
Description
General In-hospital clinical complications (yes versus no; if yes, which complications?)
Time Frame
Follow-up 15 days
Title
Days of acute hospitalization
Description
Length of hospital stay
Time Frame
Follow-up 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
IRCCS Policlinico San Donato
City
San Donato Milanese
State/Province
MI
ZIP/Postal Code
20097
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianluca Castiello
Phone
3474834455
Email
gianluca.castiello@grupposandonato.it

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Prophylactic Negative Pressure Wound Therapy (NPWT)

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