NCT05727995

Efficacy of Prophylactic Negative Pressure Wound Therapy (NPWT)

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: IRCCS Policlinico S. Donato · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wound of Skin

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-07-25
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-02-14
• Last updated: 2023-02-14

Locations

1 site across 1 country: Italy