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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2023-10-15

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.

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Negative Pressure Wound Therapy for the Prevention of Surgical Site Infection Following Lower Limb Revascularization

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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.

Conditions

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Surgical Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 parallel groups receiving different interventions

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Once it is confirmed that the patient meets the inclusion criteria, exclusion criteria have been ruled out and after signing the corresponding informed consent, randomization will be carried out. The randomization will be carried out by the research center, and the assignment will be made through opaque envelopes.

The assignment of the intervention group will be made by the nursing staff of the surgical area.

In cases where a bilateral inguinal approach coexists in the same surgical procedure, the right side will be randomized; the contralateral incision will receive alternative therapy by default.

Study Groups

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Conventional Dressing

waterproof sterile dressing OPSITE Post-Op Visible, Smith \& Nephew, UK

Group Type PLACEBO_COMPARATOR

Regular waterproof sterile dressing.

Intervention Type OTHER

Waterproof sterile dressing OPSITE Post-Op Visible, Smith \& Nephew, UK

Prophylactic negative wound pressure dressing

PICO-7, Smith \& Nephew, UK

Group Type EXPERIMENTAL

Prophylactic Negative Pressure Dressing

Intervention Type OTHER

Negative wound pressure dressing: PICO-7, Smith \& Nephew, UK

Interventions

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Regular waterproof sterile dressing.

Waterproof sterile dressing OPSITE Post-Op Visible, Smith \& Nephew, UK

Intervention Type OTHER

Prophylactic Negative Pressure Dressing

Negative wound pressure dressing: PICO-7, Smith \& Nephew, UK

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No