Absorbable Sutures in Vascular Surgery

NCT ID: NCT02935127

Last Updated: 2016-10-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-05-31

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.

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.

Conditions

Peripheral Vascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Absorbable Group

In this group of patients absorbable sutures will be used for vascular anastomoses.

Group Type: EXPERIMENTAL

Absorbable suture

Intervention Type: PROCEDURE

Vascular anastomoses will be performed with absorbable materials

Non-Absorbable Group

In this group of patients non-absorbable sutures will be used for vascular anastomoses.

Group Type: EXPERIMENTAL

Non-Absorbable suture

Intervention Type: PROCEDURE

Vascular anastomoses will be performed with non-absorbable materials

Interventions

Absorbable suture

Vascular anastomoses will be performed with absorbable materials

Intervention Type: PROCEDURE

Non-Absorbable suture

Vascular anastomoses will be performed with non-absorbable materials

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Catanzaro

OTHER

Sponsor Role: lead

Responsible Party

Prof. Raffaele Serra, MD, Ph.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raffaele Serra, M.D., PhD.

Role: PRINCIPAL_INVESTIGATOR

University Magna Graecia of Catanzaro

Stefano de Franciscis, M.D.

Role: STUDY_CHAIR

University Magna Graecia of Catanzaro

Central Contacts

Raffaele Raffaele, Raffaele

Role: CONTACT

rserra@unicz.it

+393387078043

References

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.

Reference Type: BACKGROUND

PMID: 26515222 (View on PubMed)

Other Identifiers

ER.ALL.2016.02

Identifier Type: -

Identifier Source: org_study_id