Clinical trial · Interventional
Prophylactic Negative Wound Pressure Therapy (PICO-7) Following Groin Incisions in Vascular Surgery (PICO-Vasc Study)
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
NCT04840576CI-TRIAL-00063020PICO-VascunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Surgical Wound Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic Negative Pressure Dressing | Other | — | UNRESOLVED |
| Regular waterproof sterile dressing. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Conventional Dressing
- description
- waterproof sterile dressing OPSITE Post-Op Visible, Smith \& Nephew, UK
- interventionNames
- Other: Regular waterproof sterile dressing.
- type
- EXPERIMENTAL
- label
- Prophylactic negative wound pressure dressing
- description
- PICO-7, Smith \& Nephew, UK
- interventionNames
- Other: Prophylactic Negative Pressure Dressing
Primary outcomes (1)
- measure
- Surgical Wound Infection Rate
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDCorreia 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
- DERIVEDRodriguez 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