Clinical trial · Interventional
ARTISS a Single-centre Randomised Control Study
The Influence of ARTISS on Post-operative Abdominal Drainage and Seroma Formation in DIEP/MS-TRAM Free Flap Breast Reconstruction Patients
NCT04931615CI-TRIAL-00074995ARTISScompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The Influence of ARTISS on post-operative abdominal drainage and seroma formation in DIEP/MS-TRAM free flap breast reconstruction patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Mammaplasty | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARTISS 4mL Fibrin Sealant Topical Solution (Frozen) | Drug | — | UNRESOLVED |
| no ARTISS | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- without ARTISS
- description
- Surgery performed without active comparative
- interventionNames
- Other: no ARTISS
- type
- ACTIVE_COMPARATOR
- label
- with ARTISS
- description
- Surgery performed with active comparative
- interventionNames
- Drug: ARTISS 4mL Fibrin Sealant Topical Solution (Frozen)
Primary outcomes (1)
- measure
- post-operative abdominal mean drainage duration
- timeFrame
- 42 days
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.