NCT04840576

Prophylactic Negative Wound Pressure Therapy (PICO-7) Following Groin Incisions in Vascular Surgery (PICO-Vasc Study)

Prophylactic Negative Wound Pressure Therapy (PICO-7) Following Surgery for Revascularization of Patients With Chronic Lower Limb Ischemia (PICO-Vasc Study): A Prospective Ramdomised Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Corporacion Parc Tauli · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

Comparison between waterproof sterile dressing OPSITE Post-Op Visible, Smith \& Nephew, UK and PICO-7, Smith \& Nephew, UK in terms of inguinal surgical wound infection and complications after lower limb revascularization.

Detailed description

Patients will follow a preoperative preparation: * Routine pre-surgical skin hygiene with soap or antiseptic agent * Groin shaving with a machine * Preoperative antibiotic prophylaxis with cefazolin 2 gr ev. single dose or clindamycin 900 mg ev. in case of allergy to beta-lactams 30 min before the start of the intervention. In case of prolongation of the intervention (\> 4h), a second antibiotic dose will be administered * Surgical field antisepsis using a sterile swab soaked in 2% chlorhexidine solution in 70% isopropyl alcohol, except for contraindications (such as potential contact with mucosa or open wounds, in which case 10% povidone-iodine solution will be used); usual sizing. At the end of the revascularization surgical procedure, the inguinal wound will be closed using 2-0 or 3-0 Vicryl subcutaneous absorbable suture (Ethicon Inc, Somerville, NJ, USA) in two independent planes and skin closure with metal staples (B / Braun Manipler® AZ). The opaque randomization result allocation envelope will then be opened and the surgical area nurse will cover the wound with one of the two assigned dressings: * Group 1 (intervention group): The surgical wound will be covered in a sterile manner with prophylactic TPN (PICO-7, Smith \& Nephew, UK). * Group 2 (control group): The surgical wound will be covered in a sterile way with the usual dressing (waterproof sterile dressing OPSITE Post-Op Visible, Smith \& Nephew, UK). During admission, regular follow-up will be carried out. On the 7th day, the dressings of both groups will be lifted. From this moment, if the wound allows it, air healing will be carried out without new dressings. After discharge from the hospital, the surgical wound evaluation will be carried out by the nurse responsible for Outpatient Consultations at 14 and 30 days postoperatively.

Conditions

• Surgical Wound Infection

Interventions

Type	Name	Description
OTHER	Regular waterproof sterile dressing.	Waterproof sterile dressing OPSITE Post-Op Visible, Smith \& Nephew, UK
OTHER	Prophylactic Negative Pressure Dressing	Negative wound pressure dressing: PICO-7, Smith \& Nephew, UK

Timeline

• Start date: 2021-04-15
• Primary completion: 2023-04-15
• Completion: 2023-10-15
• First posted: 2021-04-12
• Last updated: 2023-01-05

Locations

1 site across 1 country: Spain