Clinical trial NCT05727995: Efficacy of Prophylactic Negative Pressure Wound Therapy (NPWT)
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
Overall status: UNKNOWN
Phase: NA
Conditions: Wound of Skin
Keywords: negative pressure wound therapy
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: After checking the patients' eligibility they will be blindly randomized in the arm allocation (allocation 1:1).
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Leg wound assessment
timeFrame: At baseline (post-surgery)
measure: Leg wound assessment
timeFrame: At 15 days post-surgery
measure: Leg wound assessment
timeFrame: At one month post-surgery
Secondary outcomes:
measure: General in hospital complications
timeFrame: Follow-up 15 days
measure: Days of acute hospitalization
timeFrame: Follow-up 30 days
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: MI
Study officials:
References: