CLOSM Trial: Groin Closure Using Layered Option for Suture Material
ConditionVascular Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cleveland Clinic
About this trial
This is a randomized controlled trial comparing groin closure after vascular intervention with Vicryl suture versus PDS (polydioxanone) suture. This will be a single center trail performed at CCF main campus. Patients will be enrolled in a prospective fashion and will be randomized 1:1 to either PDS or Vicryl closure. Patients undergoing bilateral groin exposure will be randomized to receive both closure types to either groin.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients > 18 years who undergo ELECTIVE vascular surgery that would require groin incisions
Patients with to undergo ELECTIVE bilateral groin incisions will be matched to receive closure with PDS in one groin and Vicryl in the other groin
Disqualifiers
Age 17 or younger
Prisoners
Pregnant patients
Emergent cases
Trial design
Design model
Parallel
Treatments tested in this trial
Groin closure with PDS suture
Procedure/SurgeryClosure of the groin will be performed with PDS suture
Groin closure suture material
Procedure/SurgeryClosure of the groin will be performed with Vicryl suture
Treatment groups
259 Participants
are divided into 2 treatment groupsGroup A: Groin closure after vascular intervention with PDS sutureActive comparator 1 intervention
Group B: Groin closure after vascular intervention with Vicryl sutureActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of groin complication
Number of occurrence of the access site complication
Time frame
30 days and 1 yearSponsors and contacts
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Source ClinicalTrials.gov