Surgical Wound InfectionPICO-VascNCT04840576
Prophylactic Negative Wound Pressure Therapy (PICO-7) Following Groin Incisions in Vascular Surgery (PICO-Vasc Study)
A study testing Regular waterproof sterile dressing. and Prophylactic Negative Pressure Dressing in people with Surgical Wound Infection, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- Regular waterproof sterile dressing. and Prophylactic Negative Pressure Dressing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteSpain
- Study dates
- 15 Apr 2021to 15 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Consorcio Sanitario Parc Tauli - Hospital Universitario.
Sabadell, Barcelona, 08208
Elena Gonzalez Canas, MD PhD, 0034610755432, egonzalez@tauli.cat
Antonio Gimenez Gaibar, MD PhD, 0034629083817, agimenezg@tauli.cat
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgical Wound Infection
- Being tested
- Regular waterproof sterile dressing., Prophylactic Negative Pressure Dressing
- Keywords
- Surgical Wound Infection, Seroma, Hematoma, Lymphorrhagia, Lymphocele, Extended Hospital Admission, Postoperative Mortality
- Medical subject headings
- Surgical Wound Infection, Seroma, Hematoma, Lymphocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular waterproof sterile dressing.Other
Waterproof sterile dressing OPSITE Post-Op Visible, Smith \& Nephew, UK
Prophylactic Negative Pressure DressingOther
Negative wound pressure dressing: PICO-7, Smith \& Nephew, UK
| Study group | Role | What they receive |
|---|---|---|
| Conventional Dressing | Placebo comparator | waterproof sterile dressing OPSITE Post-Op Visible, Smith \& Nephew, UK Receives: Other: Regular waterproof sterile dressing. |
| Prophylactic negative wound pressure dressing | Experimental | PICO-7, Smith \& Nephew, UK Receives: Other: Prophylactic Negative Pressure Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Wound Infection Rate
Number of participant with surgical wound with inflammatory signs according to the treating surgeon criteria in the first 30 days.
Measured: 30 days
Secondary outcomes (9)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days
Rate of Lymphorrhagia
Number of participant with discharge of clear fluid through a surgical wound in the 30 days after surgery
Measured: 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
Measured: 30 days
Postoperative mortality Rate
Rate of death in the 30 days after surgery
Measured: 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.
Measured: 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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start15 Apr 2021
- Primary completion15 Apr 2023 (estimated)
- Study completion15 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 parallel groups receiving different interventions
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Laura Rodriguez-Lorenzo, Corporacion Parc Tauli
- Investigators
- Kerbi A Guevara Noriega, MD MSc PhD, Study chair, Vascular and Endovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840576
- Sponsor's protocol ID
- TauliCV002
- Acronym
- PICO-Vasc
- Status last verified
- Jan 2023
- First submitted
- 24 Mar 2021
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41159585Rodriguez 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.
PubMed 38677468
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04840576
- Acronym / sponsor ID
- PICO-Vasc / TauliCV002
- Conditions
- Surgical Wound Infection
- Keywords
- Surgical Wound Infection, Seroma, Hematoma, Lymphorrhagia, Lymphocele, Extended Hospital Admission, Postoperative Mortality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- 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
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 parallel groups receiving different interventions
| Arm | Type | Receives |
|---|---|---|
| Conventional Dressing | Placebo comparator | Other: Regular waterproof sterile dressing.waterproof sterile dressing OPSITE Post-Op Visible, Smith \& Nephew, UK |
| Prophylactic negative wound pressure dressing | Experimental | Other: Prophylactic Negative Pressure DressingPICO-7, Smith \& Nephew, UK |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular waterproof sterile dressing.Waterproof sterile dressing OPSITE Post-Op Visible, Smith \& Nephew, UK | Other | Conventional Dressing |
| Prophylactic Negative Pressure DressingNegative wound pressure dressing: PICO-7, Smith \& Nephew, UK | Other | Prophylactic negative wound pressure dressing |
Primary outcome
Surgical Wound Infection Rate
Time frame: 30 days
Number of participant with surgical wound with inflammatory signs according to the treating surgeon criteria in the first 30 days.
9 secondary outcomes
Surgical Wound Complications Rate
Time frame: 30 days
Seroma or lymphocele rate
Time frame: 30 days
Surgical wound dehiscence rate
Time frame: 30 days
Rate of Hematoma
Time frame: 30 days
Rate of Lymphorrhagia
Time frame: 30 days
Extended hospital admission rate
Time frame: 30 days
Postoperative mortality Rate
Time frame: 30 days
Surgical wound infection-related mortality Rate
Time frame: 30 days
Level of postoperative pain
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Derived from this study: PubMed 41159585Correia 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.
- Derived from this study: PubMed 38677468Rodriguez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerbi A Guevara Noriega, MD MSc PhD study chair
Vascular and Endovascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular waterproof sterile dressing. and Prophylactic Negative Pressure Dressing in people with Surgical Wound Infection, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura M Rodriguez, MD (0034629056699, lmrodriguez@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Wound Infection Rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04840576, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.