Absorbable Sutures in Vascular Surgery (ASPeVaS)

Absorbable Sutures in Peripheral Vascular Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Vascular Disease
• Intervention / Treatment: Procedure: Absorbable suture; Procedure: Non-Absorbable suture

Detailed Description

Infrainguinal vein graft procedures may be performed, generally, on patients with critical limb ischemia (CLI) or popliteal artery aneurysm (PAA). Autologous vein graft, when adequate and available, is usually the preferred conduit, especially in the below knee vascular districts. Vein grafts may complicate with the onset of stenoses (up to 30% of cases). Such complications may develop, due to myointimal hyperplasia along the body of the graft or, more often, at the proximal or distal anastomoses where sutures are performed. In vascular surgery procedures, in case of arterial anastomoses, absorbable suture material is generally not preferred, mainly for the fear of breakage of the suture line. Previous experimental studies performed in animals and humans and a recent clinical study performed in humans on carotid surgery showed that absorbable sutures used in vascular surgery may even reduce the development of intimal hyperplasia and may reduce postoperative stenotic complications. The aim of this study is to evaluate the early and long-term results of absorbable sutures used in peripheral vascular surgery.

This is an open-label, parallel group study.

Patients undergoing vein bass grafting for CLI or PAA may be suitable for entry into ASPeVas trial. They must satisfy the following inclusion criteria:

Both sex. Age > 18 years old. Patients undergoing femoropopliteal or femorodistal vein bypass grafting; must be able to give informed consent; have no significant co-morbidity that makes life expectancy less than six months.

The randomisation process consists as follows: once a patient have consented entering the trial, an envelop is opened and the patient is offered the type of suture (absorbable or non absorbable) regardless of the surgical technique which is going to be performed (femoropopliteal or femorodistal vein bypass grafting).

All patients have to be followed-up, the day after the operation (time 0) and then subsequently at 1, 3,6,9,12 and 18 months.

At each appointment, Ankle Brachial Pressure Index (ABPI) is measured and then Duplex scanning (DS) is performed. In particular, by means of DS the peak systolic flow velocity (PSFV) at multiple sites along the entire graft is measured. A graft at risk of failure was defined as having a PSFV < 45 cm/s or a ratio of V2 (peak velocity at the site of the stenosis) to V1 (peak systolic velocity at any other point within 2 cm at the normal adjacent graft) > 2. Any other irregularities, such as inflow/outflow problems, graft dilatation will be also recorded.

Clinical signs of a failing graft will be collected: disabling claudication, ischemic pain, ischemic ulcers.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raffaele Raffaele, Raffaele; Phone Number: +393387078043; Email: rserra@unicz.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

inclusion criteria:

• 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.

exclusion criteria:

• patients that do not meet the aforementioned criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Absorbable Group; In this group of patients absorbable sutures will be used for vascular anastomoses.	Procedure: Absorbable suture; Vascular anastomoses will be performed with absorbable materials
Experimental: Non-Absorbable Group; In this group of patients non-absorbable sutures will be used for vascular anastomoses.	Procedure: Non-Absorbable suture; Vascular anastomoses will be performed with non-absorbable materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flow Velocity in the graft	centimeters per second (cm/sec)	18 months

Collaborators and Investigators

• Sponsor: University of Catanzaro
• Investigators: Principal Investigator: Raffaele Serra, M.D., PhD., University Magna Graecia of Catanzaro; Study Chair: Stefano de Franciscis, M.D., University Magna Graecia of Catanzaro

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: October 13, 2016
• First Posted (Estimate): October 17, 2016

Study Record Updates

• Last Update Posted (Estimate): October 17, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: absorbable sutures
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: ER.ALL.2016.02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No