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

Sponsor

Corporacion Parc Tauli (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04840576

Collaborator

Kerbi Alejandro Guevara-Noriega (Other), Elena Gonzalez Canas (Other), Marta Camats Terre (Other), Eduardo Arrea Salto (Other), Antonio Giménez Gaibar (Other)

132

Enrollment

Location

Arms

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Wound Infection	Other: Regular waterproof sterile dressing. Other: Prophylactic Negative Pressure Dressing	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

132 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2 parallel groups receiving different interventions2 parallel groups receiving different interventions

Masking:

Single (Participant)

Masking Description:

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.

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Apr 15, 2021

Anticipated Primary Completion Date :

Apr 15, 2022

Anticipated Study Completion Date :

Oct 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Conventional Dressing waterproof sterile dressing OPSITE Post-Op Visible, Smith & Nephew, UK	Other: Regular waterproof sterile dressing. Waterproof sterile dressing OPSITE Post-Op Visible, Smith & Nephew, UK
Experimental: Prophylactic negative wound pressure dressing PICO-7, Smith & Nephew, UK	Other: Prophylactic Negative Pressure Dressing Negative wound pressure dressing: PICO-7, Smith & Nephew, UK

Arm

Intervention/Treatment

Placebo Comparator: Conventional Dressing

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

Other: Regular waterproof sterile dressing.

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

Experimental: Prophylactic negative wound pressure dressing

PICO-7, Smith & Nephew, UK

Other: Prophylactic Negative Pressure Dressing

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

Outcome Measures

Primary Outcome Measures

Surgical Wound Infection Rate [30 days]
Number of participant with surgical wound with inflammatory signs according to the treating surgeon criteria in the first 30 days.

Secondary Outcome Measures

Surgical Wound Complications Rate [30 days]
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.
Seroma or lymphocele rate [30 days]
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
Surgical wound dehiscence rate [30 days]
Number of participant with separation of the edges of part or all of a previously sutured wound in the 30 days after surgery
Rate of Hematoma [30 days]
Number of participant with blood collection organized in the surgical bed of a closed wound in the 30 days after surgery
Rate of Lymphorrhagia [30 days]
Number of participant with discharge of clear fluid through a surgical wound in the 30 days after surgery
Extended hospital admission rate [30 days]
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
Postoperative mortality Rate [30 days]
Rate of death in the 30 days after surgery
Surgical wound infection-related mortality Rate [30 days]
Rate of mortality secondary to infection of the surgical wound or due to causes related to complications of the inguinal surgical wound.
Level of postoperative pain [7 days]
Measurement of postoperative pain in the 7 days after surgery. Carried out using the visual analog scale (VAS) applied to the patient

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.