ARTISS a Single-centre Randomised Control Study | NCT04931615

Studies
ARTISS a Single-centre Randomised Control Study

NCT04931615

Sponsor

Mid and South Essex NHS Foundation Trust

Status

Completed

Last Update Posted

Mar 13, 2024Actual

Enrollment

135Actual

Phase

Phase 4

Conditions

Breast Neoplasms
Mammaplasty

Interventions

ARTISS 4mL Fibrin Sealant Topical Solution (Frozen)
no ARTISS

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2021-002624-20	EudraCT Number

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2022Actual

Primary Completion Date

Feb 28, 2023Actual

Completion Date

Feb 28, 2023Actual

First Submitted Date

Jun 11, 2021

First Submission Date that Met QC Criteria

Jun 16, 2021

First Posted Date

Jun 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2024

Last Update Posted Date

Mar 13, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Influence of ARTISS on post-operative abdominal drainage and seroma formation in DIEP/MS-TRAM free flap breast reconstruction patients.

Detailed Description

The principle aim of the study is to investigate the effect of ARTISS on abdominal wound drainage whether this could result in earlier drain removal and earlier patient discharge from hospital. The primary outcome investigated will be post- operative abdominal drainage duration in days which is vital information during this Covid pandemic to reduce hospital stay (and therefore possible Covid exposure) which could result in earlier discharge from hospital, as well as significantly reducing cost of the procedure to the NHS and frees in-patient beds for more efficient use of resources.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

135Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
without ARTISS	Placebo Comparator	Surgery performed without active comparative	Other: no ARTISS
with ARTISS	Active Comparator	Surgery performed with active comparative	Drug: ARTISS 4mL Fibrin Sealant Topical Solution (Frozen)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARTISS 4mL Fibrin Sealant Topical Solution (Frozen)	Drug	Wound sealant	with ARTISS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
post-operative abdominal mean drainage duration	post-operative abdominal mean drainage duration	42 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female adult (age 18-80)
Patients planned for immediate or delayed DIEP/MS-TRAM breast reconstruction

Exclusion Criteria:

Patients who are unable to consent or do not consent
Clotting disorder
Pregnancy
Individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia).
COVID positive
Known previous allergic reactions to ARTISS

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mary Morgan, MD	Mid and South Essex NHS Foundation Trust	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mid and South Essex NHS Foundation Trust		Broomfield	Essex	CM1 7ET	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005615	Freezing

Ancestor Terms

ID	Term
D044367	Phase Transition
D055585	Physical Phenomena
D003080	Cold Temperature
D013696	Temperature

Browse Leaves

Not provided

Browse Branches

Not provided