ARTISS a Single-centre Randomised Control Study

• Sponsor: Mid and South Essex NHS Foundation Trust (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04931615
• Collaborator: (none)
• Enrollment: 138
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17.9
• Patients Per Site Per Month: 7.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms; Mammaplasty	Drug: ARTISS 4mL Fibrin Sealant Topical Solution (Frozen); Other: no ARTISS	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 138 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomised controlled trialRandomised controlled trial
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Blinded patient and blinded assessor
• Primary Purpose: Treatment
• Official Title: The Influence of ARTISS on Post-operative Abdominal Drainage and Seroma Formation in DIEP/MS-TRAM Free Flap Breast Reconstruction Patients
• Actual Study Start Date: Feb 1, 2022
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: without ARTISS Surgery performed without active comparative	Other: no ARTISS; Wound closed without sealant
Active Comparator: with ARTISS Surgery performed with active comparative	Drug: ARTISS 4mL Fibrin Sealant Topical Solution (Frozen); Wound sealant

Outcome Measures

Primary Outcome Measures

1. post-operative abdominal mean drainage duration [42 days]

   post-operative abdominal mean drainage duration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mid and South Essex NHS Foundation Trust	Broomfield	Essex	United Kingdom	CM1 7ET

Sponsors and Collaborators

• Mid and South Essex NHS Foundation Trust

Investigators

• Study Chair: Mary Morgan, MD, Mid and South Essex NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mid and South Essex NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT04931615
• Other Study ID Numbers: 287482; 2021-002624-20
• First Posted: Jun 18, 2021
• Last Update Posted: Apr 13, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mid and South Essex NHS Foundation Trust: muscle-sparing transverse rectus abdominis myocutaneous flap; Deep Inferior Epigastric Artery Perforator
• Additional relevant MeSH terms: Breast Neoplasms; Fibrin Tissue Adhesive; Thrombin

Study Results

No Results Posted as of Apr 13, 2022