Clinical trial NCT04840576: Prophylactic Negative Wound Pressure Therapy (PICO-7) Following Groin Incisions in Vascular Surgery (PICO-Vasc Study)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Wound Infection
Keywords: Surgical Wound Infection
Seroma
Hematoma
Lymphorrhagia
Lymphocele
Extended Hospital Admission
Postoperative Mortality
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Kerbi Alejandro Guevara-Noriega, Sabadell, Parc Tauli, Spain
name: Elena Gonzalez Canas, Sabadell, Parc Tauli, Spain
name: Marta Camats Terre, Sabadell, Parc Tauli, Spain
name: Eduardo Arrea Salto, Sabadell, Parc Tauli, Spain
name: Antonio Giménez Gaibar, Sabadell, Parc Tauli, Spain
name: Marta Santos Espi, Sabadell, Parc Tauli, Spain
First posted: 2021-04-12
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 parallel groups receiving different interventions
Primary purpose: PREVENTION

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Surgical Wound Infection Rate
timeFrame: 30 days
Secondary outcomes:
measure: Surgical Wound Complications Rate
timeFrame: 30 days
measure: Seroma or lymphocele rate
timeFrame: 30 days
measure: Surgical wound dehiscence rate
timeFrame: 30 days
measure: Rate of Hematoma
timeFrame: 30 days
measure: Rate of Lymphorrhagia
timeFrame: 30 days
measure: Extended hospital admission rate
timeFrame: 30 days
measure: Postoperative mortality Rate
timeFrame: 30 days
measure: Surgical wound infection-related mortality Rate
timeFrame: 30 days
measure: Level of postoperative pain
timeFrame: 7 days
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Consorcio Sanitario Parc Tauli - Hospital Universitario.
state: Barcelona
Study officials:
affiliation: Vascular and Endovascular Surgery
name: Kerbi A Guevara Noriega, MD MSc PhD
role: STUDY_CHAIR
References: