Wound of Skin
Conditions
Keywords
negative pressure wound therapy
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.
Interventions
DEVICEPICO7
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.
OTHERusual care dressing
usual care dressing
Sponsors
IRCCS Policlinico S. Donato
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The statistician generates the random list and the outcome assessors guarantee the blinding procedure.
Intervention model description
After checking the patients' eligibility they will be blindly randomized in the arm allocation (allocation 1:1).
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leg wound assessment | At baseline (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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed