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NCT04904653
Randomized Controlled and Single Blind Clinical Trial in Women With Breast Cancer and Axillary Lymphadenectomy, to Evaluate the Effectiveness of Hemopatch® in the Reduction of Post-surgical Serous Drainage
Phase 4 trial testing Hemopatch in Hemopatch in 118 participants. Status unknown.
1 December 2024
Quick facts
| Lead sponsor | Instituto de Investigación Hospital Universitario La Paz |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | other |
| Enrollment | 118 |
| Start date | 8 November 2021 |
| Primary completion | 1 December 2024 |
| Estimated completion | 1 December 2024 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Hemopatch
- Control group — full drug profile →
Conditions studied
- Hemopatch — all drugs for Hemopatch →
- Breast Cancer — all drugs for Breast Cancer →
- Axillary Lymphadenectomy — all drugs for Axillary Lymphadenectomy →
Sponsor
Instituto de Investigación Hospital Universitario La Paz
Who can join
18 and older, female only, with Hemopatch or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Total volume in milliliters (ml) of drainage
Time frame: In the last 24 hours
Total volume in milliliters (ml) of drainage: To be measured in the hospital every day before discharge, and collected daily after discharge with a follow-up of phone calls or patient diaries during hospital visits until extraction drain.
Sponsor's own description
Hemopatch is an alternative to reduce morbidity associated with axillary lymphadenectomy surgery, possibly contributing to improved patient management, clinical outcomes, and hospital costs. We propose a multicenter, controlled, and randomized trial to study the efficacy of Hemopatch in reducing serous wound drainage.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Stimuli-responsive hydrogel based on natural polymers for breast cancer.
Asadi K, Samiraninezhad N, Akbarizadeh AR, Amini A, et al · · 2024 · cited 19× · PMID 38304867 · DOI 10.3389/fchem.2024.1325204
Verify or expand the search:
- PubMed search for NCT04904653
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Hemopatch
Trials testing the same drug.
- NCT04185480 — Evaluating Hemopatch in Reducing Seroma Related Complications Following Axillary Lymph Node Dissection: a Pilot Study · NA · completed
- NCT04185922 — Hemopatch to Prevent Lymphatic Leak After Robotic Prostatectomy and Pelvic Lymph Node Dissection · NA · completed
- NCT03993067 — Hemopatch as a Tool to Prevent Biliary Fistula in Liver Surgery. · NA · completed
- NCT03410914 — Intra-operative Application of HEMOPATCH to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following · Phase 2 · completed
- NCT03450265 — Hemopatch Compared to TachoSil in Postoperative Air Leak Duration After Pulmonary Resection · NA · completed
Other Instituto de Investigación Hospital Universitario La Paz trials
Trials by the same sponsor.
- NCT06709469 — Phase I Clinical Trial of CART Cell Therapy for Refractory/Relapsed Acute Lymphoblastic Leukemia in Children, Adolescent · Phase 1 · recruiting
- NCT06701825 — Effectiveness and Cost-effectiveness of a Pre-emptive Genotyping Strategy in Patients Receiving Tacrolimus · Phase 4 · recruiting
- NCT06488898 — Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts · Phase 2 · recruiting
- NCT06273306 — Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model (IMIDOC) · NA · not yet recruiting
- NCT06302647 — Assessing Interest in Web/App Platforms for Early Phase Clinical Trial Recruitment · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04904653 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Instituto de Investigación Hospital Universitario La Paz
- Last refreshed: 5 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04904653.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing