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| Name | Class |
|---|---|
| Kerbi Alejandro Guevara-Noriega, Sabadell, Parc Tauli, Spain | UNKNOWN |
| Elena Gonzalez Canas, Sabadell, Parc Tauli, Spain | UNKNOWN |
| Marta Camats Terre, Sabadell, Parc Tauli, Spain | UNKNOWN |
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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.
Patients will follow a preoperative preparation:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Dressing | Placebo Comparator | waterproof sterile dressing OPSITE Post-Op Visible, Smith & Nephew, UK |
|
| Prophylactic negative wound pressure dressing | Experimental | PICO-7, Smith & Nephew, UK |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular waterproof sterile dressing. | Other | Waterproof sterile dressing OPSITE Post-Op Visible, Smith & Nephew, UK |
|
| 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 |
| 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:
| 30 days |
| Seroma or lymphocele rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura M Rodriguez, MD | Contact | 0034629056699 | lmrodriguez@tauli.cat | |
| Kerbi A Guevara Noriega, MD MSc PhD | Contact | 0034628888896 | kaguevara@tauli.cat |
| Name | Affiliation | Role |
|---|---|---|
| Kerbi A Guevara Noriega, MD MSc PhD | Vascular and Endovascular Surgery | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consorcio Sanitario Parc Tauli - Hospital Universitario. | Recruiting | Sabadell | Barcelona | 08208 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41159585 | Derived | 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. | |
| 38677468 | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 7, 2023 | |
| Reset | Mar 8, 2024 |
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| Eduardo Arrea Salto, Sabadell, Parc Tauli, Spain | UNKNOWN |
| Antonio Giménez Gaibar, Sabadell, Parc Tauli, Spain | UNKNOWN |
| Marta Santos Espi, Sabadell, Parc Tauli, Spain | UNKNOWN |
2 parallel groups receiving different interventions
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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.
| Prophylactic Negative Pressure Dressing | Other | Negative wound pressure dressing: PICO-7, Smith & Nephew, UK |
|
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 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 7, 2023 | Mar 8, 2024 |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D049291 | Seroma |
| D006406 | Hematoma |
| D008210 | Lymphocele |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007249 | Inflammation |
| D006470 | Hemorrhage |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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