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

Surgical Wound Infection Clinical Trial

— PICO-Vasc  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04840576
• Other study ID #: TauliCV002
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: October 15, 2023

Study information

• Verified date: January 2023
• Source: Corporacion Parc Tauli
• Contact: Laura M Rodriguez, MD
• Phone: 0034629056699
• Email: lmrodriguez[@]tauli.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: October 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Surgical Wound
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

Other:
• Regular waterproof sterile dressing.
Waterproof sterile dressing OPSITE Post-Op Visible, Smith & Nephew, UK
• Prophylactic Negative Pressure Dressing
Negative wound pressure dressing: PICO-7, Smith & Nephew, UK

Locations

Country	Name	City	State
Spain	Consorcio Sanitario Parc Tauli - Hospital Universitario.	Sabadell	Barcelona

Sponsors (7)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Antonio Giménez Gaibar, Sabadell, Parc Tauli, Spain, Eduardo Arrea Salto, Sabadell, Parc Tauli, Spain, Elena Gonzalez Canas, Sabadell, Parc Tauli, Spain, Kerbi Alejandro Guevara-Noriega, Sabadell, Parc Tauli, Spain, Marta Camats Terre, Sabadell, Parc Tauli, Spain, Marta Santos Espi, Sabadell, Parc Tauli, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate of Lymphorrhagia	Number of participant with discharge of clear fluid through a surgical wound in the 30 days after surgery	30 days
Secondary	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
Secondary	Postoperative mortality Rate	Rate of death in the 30 days after surgery	30 days
Secondary	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
Secondary	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