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

NCT04840576 | Unknown

• 1 other identifier: TauliCV002
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Wound Infection

Keywords

Surgical Wound Infection; Seroma; Hematoma; Lymphorrhagia; Lymphocele; Extended Hospital Admission; Postoperative Mortality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Surgical Wound Complications Rate

  30 days

• Seroma or lymphocele rate

  30 days

• Surgical wound dehiscence rate

  30 days

• Rate of Hematoma

  30 days

• Rate of Lymphorrhagia

  30 days

Study Arms (2)

Conventional Dressing

PLACEBO COMPARATOR

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

Other: Regular waterproof sterile dressing.

Prophylactic negative wound pressure dressing

EXPERIMENTAL

PICO-7, Smith \& Nephew, UK

Other: Prophylactic Negative Pressure Dressing

Interventions

Regular waterproof sterile dressing. OTHER

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

Conventional Dressing

Prophylactic Negative Pressure Dressing OTHER

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

Prophylactic negative wound pressure dressing

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• Kerbi Alejandro Guevara-Noriega, Sabadell, Parc Tauli, Spain: collaborator
• Elena Gonzalez Canas, Sabadell, Parc Tauli, Spain: collaborator
• Marta Camats Terre, Sabadell, Parc Tauli, Spain: collaborator
• Eduardo Arrea Salto, Sabadell, Parc Tauli, Spain: collaborator
• Antonio Giménez Gaibar, Sabadell, Parc Tauli, Spain: collaborator
• Marta Santos Espi, Sabadell, Parc Tauli, Spain: collaborator

Study Sites (1)

Consorcio Sanitario Parc Tauli - Hospital Universitario.

Sabadell, Barcelona, 08208, Spain

RECRUITING

Related Publications (2)

• Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.

  PMID: 41159585 DERIVED

• Rodriguez Lorenzo L, Salto EA, Gonzalez Canas E, Madrazo Gonzalez Z, Espi MS, Gimenez Gaibar A. Incisional Negative Pressure Wound Therapy After Revascularisation Surgery in Patients with Peripheral Arterial Disease: A Randomised Trial (PICO-Vasc Study). Eur J Vasc Endovasc Surg. 2024 Aug;68(2):238-244. doi: 10.1016/j.ejvs.2024.04.031. Epub 2024 Apr 25.

  PMID: 38677468 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection; Seroma; Hematoma; Lymphocele

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation; Hemorrhage; Cysts; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Kerbi A Guevara Noriega, MD MSc PhD

  Vascular and Endovascular Surgery

  STUDY CHAIR

Central Study Contacts

Laura M Rodriguez, MD

CONTACT

0034629056699; lmrodriguez@tauli.cat

Kerbi A Guevara Noriega, MD MSc PhD

CONTACT

0034628888896; kaguevara@tauli.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular and Endovascular Surgeon

Model Details: 2 parallel groups receiving different interventions

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 12, 2021
• Study Start: April 15, 2021
• Primary Completion: April 15, 2023
• Study Completion: October 15, 2023
• Last Updated: January 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)