Status:
UNKNOWN
Prophylactic Negative Wound Pressure Therapy (PICO-7) Following Groin Incisions in Vascular Surgery (PICO-Vasc Study)
Lead Sponsor:
Corporacion Parc Tauli
Collaborating Sponsors:
Kerbi Alejandro Guevara-Noriega, Sabadell, Parc Tauli, Spain
Elena Gonzalez Canas, Sabadell, Parc Tauli, Spain
Conditions:
Surgical Wound Infection
Eligibility:
All Genders
18-95 years
Phase:
NA
Brief 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 l...
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 ...
Eligibility Criteria
Inclusion
- Age: 18-90
- Undergoing elective revascularization surgery (Rutherford clinical categories 4-6 / Fontaine III and IV) requiring a longitudinal inguinal approach (a longitudinal inguinal incision is defined as the one that runs from the inguinal ligament to the femoral bifurcation, performed with the intention of approaching the vascular bundle).
- Surgery performed by investigator and co-investigators: Vascular Surgeons of the Vascular Surgery Department at the Parc Taulí Hospital.
- Patients must be able to understand the study and sign the specific informed consent before surgery.
Exclusion
- Urgent surgery
- Interventions in which transverse groin wounds.
- Presence of active groin infection that prevents primary closure
- Pediatric patients, pregnant women or patients with impaired higher functions who cannot understand the study or collaborate with its protocolized follow-up.
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2023
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04840576
Start Date
April 15 2021
End Date
October 15 2023
Last Update
January 5 2023
Active Locations (1)
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1
Consorcio Sanitario Parc Tauli - Hospital Universitario.
Sabadell, Barcelona, Spain, 08208