Efficacy of Prophylactic Negative Pressure Wound Therapy (NPWT)

Wound of Skin Clinical Trial

— 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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05727995
• Other study ID #: 126/int/2019
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2019
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: IRCCS Policlinico S. Donato
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wound of Skin
• Wounds and Injuries

Intervention

Device:
• 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.

Other:
• usual care dressing
usual care dressing

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Donato	San Donato Milanese	MI

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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	General in hospital complications	General In-hospital clinical complications (yes versus no; if yes, which complications?)	Follow-up 15 days
Secondary	Days of acute hospitalization	Length of hospital stay	Follow-up 30 days