CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 501 enrolled
Drug / intervention
Spiral PDS Plus +4 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03792737
NCT03792737N/ACompleted
CompareCT.gov

A Prospective, Multi-center, Randomized Controlled Study Evaluating the Efficacy and Safety of Two Types of Absorbable Surgical Sutures in the Suturing of Thyroid Surgery Incision

Ethicon, Inc.·interventional·Posted Jan 3, 2019·Updated Apr 5, 2022

In Brief

A clinical study evaluating Spiral PDS Plus, Spiral MONOCRYL Plus, and 3 other interventions for Sutures. Completed, enrolled 501 participants across 10 sites.

Detailed Summary

The primary objective of this study is to evaluate the efficacy and safety of two types of absorbable surgical sutures -- STRATAFIX Spiral PDS Knotless Plus Tissue Control Device and STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device (hereinafter referred to as Spiral PDS Plus and Spiral MONOCRYL Plus) used in thyroid surgery to suture surgical incision.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSutures
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 3, 2019
Enrollment StartApr 1, 2019
Primary CompletionDec 12, 2019
Study CompletionJan 6, 2020
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.5 years ago

Interventions

Spiral PDS Plusdevice

The Spiral PDS Plus is an antibacterial monofilament, synthetic absorbable device. It contains triclosan, a broad spectrum antibacterial agent. The device consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. Spiral PDS Plus barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.

Spiral MONOCRYL Plusdevice

The Spiral MONOCRYL Plus is an antibacterial monofilament, synthetic absorbable device. It contains triclosan, a broad spectrum antibacterial agent. The device consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. Spiral MONOCRYL Plus barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.

PDS Plusdevice

PDS Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.

MONOCRYL Plusdevice

MONOCRYL Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.

VICRYL Plusdevice

VICRYL Plus antibacterial suture is a non-barbed synthetic absorbable sterile, surgical suture. The suture contains triclosan, a broad spectrum antibacterial agent.