Absorbable Sutures in Vascular Surgery
ASPeVaS
Absorbable Sutures in Peripheral Vascular Surgery
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
Absorbable sutures are not generally accepted by the majority of vascular surgeons for the possible complications such as the breakage of the suture at the anastomoses level. Some experimental and clinical studies in the current literature demonstrated that the use of absorbable sutures may even reduce some important complications such as restenosis. The aim of this study is to compare absorbable and non-absorbable sutures in patients undergoing peripheral vascular surgery with vein bypass grafting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2016
CompletedFirst Posted
Study publicly available on registry
October 17, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedOctober 17, 2016
October 1, 2016
5 months
October 13, 2016
October 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Flow Velocity in the graft
centimeters per second (cm/sec)
18 months
Study Arms (2)
Absorbable Group
EXPERIMENTALIn this group of patients absorbable sutures will be used for vascular anastomoses.
Non-Absorbable Group
EXPERIMENTALIn this group of patients non-absorbable sutures will be used for vascular anastomoses.
Interventions
Vascular anastomoses will be performed with absorbable materials
Vascular anastomoses will be performed with non-absorbable materials
Eligibility Criteria
You may qualify if:
- Patients undergoing femoropopliteal or femorodistal vein bypass grafting;
- Patients able to give informed consent;
- Patients having no significant co-morbidity that makes life expectancy less than six months.
You may not qualify if:
- patients that do not meet the aforementioned criteria.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Gasbarro V, Traina L, Mascoli F, Coscia V, Buffone G, Grande R, Fugetto F, Butrico L, de Franciscis S, Serra R. Absorbable suture material in carotid surgery. Vasa. 2015 Nov;44(6):451-7. doi: 10.1024/0301-1526/a000468.
PMID: 26515222BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raffaele Serra, M.D., PhD.
University Magna Graecia of Catanzaro
- STUDY CHAIR
Stefano de Franciscis, M.D.
University Magna Graecia of Catanzaro
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 13, 2016
First Posted
October 17, 2016
Study Start
November 1, 2016
Primary Completion
April 1, 2017
Study Completion
May 1, 2018
Last Updated
October 17, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share