NCT03371316

Brief Summary

The goal of this study is to demonstrate that ViaShield™ amnion patch is effective in preventing fibroblast activity and hence soft tissue adhesions after a hemicraniectomy.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2018

Status
withdrawn

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

December 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 20, 2018

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

10 days

First QC Date

December 7, 2017

Last Update Submit

February 13, 2018

Conditions

Hemicraniectomies

Outcome Measures

Primary Outcomes (1)

  • Adhesion

    Adhesion tenacity scores post hemicraniectomies 0 No adhesions 1. Thin membranous adhesions, no vessel attachment 2. Mild adhesions, blunt dissection required 3. Moderate adhesions, some sharp dissection required 4. Tenacious adhesions, sharp instrument dissection required, vessels attached The lower the score the better the outcome for the patient

    4-8 months

Secondary Outcomes (2)

  • Infections

    From time of surgery to 8 months post-operative

  • hydrocephalus

    From time of surgery to 8 months post-operative

Study Arms (1)

Hemicraniectomy Surgery with Viashield

EXPERIMENTAL

All patients requiring a hemicraniectomy surgery will receive the anti-adhesion barrier of amnion patch.

Biological: ViaShield

Interventions

ViaShieldBIOLOGICAL

Anti-adhesion scores using amnion patch

Hemicraniectomy Surgery with Viashield

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age minimum Informed consent signed by patient or next of kin

You may not qualify if:

  • Immunosuppressive disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All patients requiring a hemicraniectomy will also receive the amnion patch as an anti-adhesive barrier
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 13, 2017

Study Start

January 20, 2018

Primary Completion

January 30, 2018

Study Completion

January 30, 2018

Last Updated

February 15, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share