NCT04931615

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

June 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

March 13, 2024

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

June 11, 2021

Last Update Submit

March 12, 2024

Conditions

Breast NeoplasmsMammaplasty

Keywords

muscle-sparing transverse rectus abdominis myocutaneous flapDeep Inferior Epigastric Artery Perforator

Outcome Measures

Primary Outcomes (1)

  • post-operative abdominal mean drainage duration

    post-operative abdominal mean drainage duration

    42 days

Study Arms (2)

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

ARTISS 4mL Fibrin Sealant Topical Solution (Frozen)DRUG

Wound sealant

with ARTISS
no ARTISSOTHER

Wound closed without sealant

without ARTISS

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mid and South Essex NHS Foundation Trust

Broomfield, Essex, CM1 7ET, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Freezing

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phase TransitionPhysical PhenomenaCold TemperatureTemperatureThermodynamicsChemical Phenomena

Study Officials

  • Mary Morgan, MD

    Mid and South Essex NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Blinded patient and blinded assessor
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2021

First Posted

June 18, 2021

Study Start

February 1, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

March 13, 2024

Record last verified: 2023-10

Locations

GB(1)