Status:
UNKNOWN
Negative Pressure Incision Management System in Infrainguinal Vascular Surgery
Lead Sponsor:
Karolinska University Hospital
Collaborating Sponsors:
Stockholm South General Hospital
Conditions:
Postoperative Surgical Site Infection
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Negative pressure wound therapy (NPWT) has been used in treating postoperative SSI with encouraging results and is now an accepted element in the arsenal of tools for treating these complications. The...
Detailed Description
Intervention and Surveillance: The groin incisions in the intervention group will have NPWT dressing, applied under sterile conditions in the operating room. The NPWT will remain on the patient until...
Eligibility Criteria
Inclusion
- Patients older than 18 years.
- The clinical criterion for study entry is elective:
- a. Open infrainguinal vascular surgery for peripheral arterial disease
- i. Thrombendarterectomy (TEA) ii. Bypass surgery with vein or synthetic graft
- Patients on whom complete seal of NPWT can be maintained during the first 24 hours after operation.
- \-
Exclusion
- All emergency cases.
- Infrainguinal endovascular procedures.
- Pre-existing groin infections.
- Sensitivity/allergy to materials used in NPWT dressing.
- Patients on whom an adequate and complete seal of NPWT dressing cannot be obtained.
- Unwillingness to participate. -
Key Trial Info
Start Date :
January 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT03395613
Start Date
January 22 2018
End Date
March 1 2023
Last Update
April 7 2022
Active Locations (1)
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1
Karolinska university Hospital
Stockholm, Sweden, 17176