NCT03940560

Brief Summary

Determine whether Mesh Suture achieves an acceptable safety and efficacy profile in load bearing internal tissue approximations. Mesh Suture has a novel design that permits tissue ingrowth and limits suture pull-through--items important for internal high-tension repairs

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

6.5 years

First QC Date

April 28, 2019

Last Update Submit

December 9, 2023

Conditions

Suture; Complications, MechanicalSuture; Complications, Infection or InflammationSuture, Complication

Keywords

suturesuture pull-throughsuture sinus

Outcome Measures

Primary Outcomes (1)

  • Surgery healing complication, acute

    Number of patients with infection, drainage, seroma, wound disruption over the mesh suture closure

    30 days

Secondary Outcomes (1)

  • Surgery healing complication, delayed

    Within 12 months

Study Arms (1)

Duramesh Suturable Mesh

EXPERIMENTAL

Use of Duramesh Suturable Mesh for internal load bearing closures

Device: Duramesh Suturable Mesh

Interventions

Duramesh Suturable MeshDEVICE

Use of Duramesh Suturable Mesh for internal load bearing closures

Duramesh Suturable Mesh

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Deep orthopedic soft tissue approximation

You may not qualify if:

  • Pregnancy
  • Age less than 1 year old
  • Repair of skin or other epithelial surfaces
  • Poor subcutaneous tissues
  • Ongoing infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wigmore Clinic

Yerevan, 0001, Armenia

Location

MeSH Terms

Conditions

InfectionsInflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Garen Koloyan, MD PhD

    Wigmore Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Safety and efficacy study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2019

First Posted

May 7, 2019

Study Start

July 1, 2018

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

December 15, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)