An interventional study of PICO7 and usual care dressing in Wound of Skin, sponsored by IRCCS Policlinico S. Donato. Status unknown at 1 site in Italy. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-02-14.
Sponsored by IRCCS Policlinico S. Donato · Not applicable, Interventional, and Prevention
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.
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 100 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →IRCCS Policlinico S. Donato is the lead sponsor of 101 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
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.
Device: PICO7
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.
Other: usual care dressing
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.
usual care dressing
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.
Time frame: At baseline (post-surgery)
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.
Time frame: At 15 days post-surgery
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.
Time frame: At one month post-surgery
General in hospital complications
General In-hospital clinical complications (yes versus no; if yes, which complications?)
Time frame: Follow-up 15 days
Days of acute hospitalization
Length of hospital stay
Time frame: Follow-up 30 days
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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IRCCS Policlinico S. Donato