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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgical Wound Infection
• Intervention / Treatment: Other: Regular waterproof sterile dressing.; Other: Prophylactic Negative Pressure Dressing

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.

• Study Type: Interventional
• Enrollment (Anticipated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura M Rodriguez, MD; Phone Number: 0034629056699; Email: lmrodriguez@tauli.cat
• Study Contact Backup: Name: Kerbi A Guevara Noriega, MD MSc PhD; Phone Number: 0034628888896; Email: kaguevara@tauli.cat

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Recruiting
      • Consorcio Sanitario Parc Tauli - Hospital Universitario.
      • Contact: Elena Gonzalez Canas, MD PhD; Phone Number: 0034610755432; Email: egonzalez@tauli.cat
      • Contact: Antonio Gimenez Gaibar, MD PhD; Phone Number: 0034629083817; Email: agimenezg@tauli.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Collaborators: Kerbi Alejandro Guevara-Noriega, Sabadell, Parc Tauli, Spain; Elena Gonzalez Canas, Sabadell, Parc Tauli, Spain; Marta Camats Terre, Sabadell, Parc Tauli, Spain; Eduardo Arrea Salto, Sabadell, Parc Tauli, Spain; Antonio Giménez Gaibar, Sabadell, Parc Tauli, Spain; Marta Santos Espi, Sabadell, Parc Tauli, Spain
• Investigators: Study Chair: Kerbi A Guevara Noriega, MD MSc PhD, Vascular and Endovascular Surgery

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Anticipated): April 15, 2023
• Study Completion (Anticipated): October 15, 2023

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Seroma; Surgical Wound Infection; Postoperative Mortality; Hematoma; Lymphorrhagia; Lymphocele; Extended Hospital Admission
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wounds and Injuries; Surgical Wound; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: TauliCV002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No