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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Surgical Wound Infection

Intervention / Treatment
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* Other: Regular waterproof sterile dressing.
* Other: Prophylactic Negative Pressure Dressing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 parallel groups receiving different interventions
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Conventional Dressing<br>waterproof sterile dressing OPSITE Post-Op Visible, Smith & Nephew, UK | Other: Regular waterproof sterile dressing.<br>* Waterproof sterile dressing OPSITE Post-Op Visible, Smith & Nephew, UK<br>|
| Experimental: Prophylactic negative wound pressure dressing<br>PICO-7, Smith & Nephew, UK | Other: Prophylactic Negative Pressure Dressing<br>* Negative wound pressure dressing: PICO-7, Smith & Nephew, UK<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Wound Infection Rate | Number of participant with surgical wound with inflammatory signs according to the treating surgeon criteria in the first 30 days. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Wound Complications Rate | Number of participant with surgical wound complications according to medical criteria of any of the following signs: Seroma or lymphocele Surgical wound dehiscence Hematoma Lymphorrhagia To be measured in 30 days. | 30 days | 
| Seroma or lymphocele rate | Number of participant with subcutaneous non-hematic liquid collection in the surgical bed of a closed wound. Its suspicion according to medical criteria will require puncture drainage and microbiological culture in 30 days after surgery | 30 days | 
| Surgical wound dehiscence rate | Number of participant with separation of the edges of part or all of a previously sutured wound in the 30 days after surgery | 30 days | 
| Rate of Hematoma | Number of participant with blood collection organized in the surgical bed of a closed wound in the 30 days after surgery | 30 days | 
| Rate of Lymphorrhagia | Number of participant with discharge of clear fluid through a surgical wound in the 30 days after surgery | 30 days | 
| Extended hospital admission rate | Number of participant with prolonged admission of more than 14 days due to cause/s related to the inguinal surgical wound complications or the need for reoperation, as well as, hospital readmission due to problems related to the inguinal surgical wound | 30 days | 
| Postoperative mortality Rate | Rate of death in the 30 days after surgery | 30 days | 
| Surgical wound infection-related mortality Rate | Rate of mortality secondary to infection of the surgical wound or due to causes related to complications of the inguinal surgical wound. | 30 days | 
| Level of postoperative pain | Measurement of postoperative pain in the 7 days after surgery. Carried out using the visual analog scale (VAS) applied to the patient | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical Wound Infection, Seroma, Hematoma, Lymphorrhagia, Lymphocele, Extended Hospital Admission, Postoperative Mortality