Using Hemopatch to reduce fluid drainage after breast cancer surgery
Official title: 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
Run by Instituto de Investigación Hospital Universitario La Paz · NCT04904653 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study tests if using Hemopatch after breast cancer surgery can help reduce fluid buildup for patients.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 118 (estimated) |
| Sponsor | Instituto de Investigación Hospital Universitario La Paz Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toledo) |
| Trial ID | NCT04904653 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are female patients aged 18 and older with breast cancer who are undergoing axillary lymphadenectomy and have had at least 10 axillary nodes removed.
✕Probably not a fit
Patients who have undergone mastectomy or have previous radiation therapy or axillary emptying may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of Hemopatch, a surgical product, in minimizing serous drainage following axillary lymphadenectomy in breast cancer patients. It is a multicenter, controlled, and randomized trial designed to compare outcomes between patients receiving Hemopatch and those in a control group. The study aims to improve patient management and clinical outcomes while potentially reducing hospital costs associated with postoperative care.
Why it matters
Potential benefit: If successful, this approach could lead to reduced postoperative complications and improved recovery for breast cancer patients undergoing surgery.
How similar studies have gone: While the specific use of Hemopatch in this context may be novel, similar studies have shown promising results in reducing postoperative complications with other surgical interventions.
Who can join: the full rules
Show full inclusion / exclusion criteria
INCLUSION CRITERIA Preoperative: * Female gender * Age ≥ 18 years * Breast cancer N+ * Conservative Surgery: Lumpectomy or Quadrantectomy * Berg levels 1-2 axillary lymphadenectomy Intraoperative: * Axillary incision separated from the incision for the breast lesion * Placement of a closed low pressure suction drain in the axillary fossa * Hemostasis and lymphostasis using clips, electrocautery, electric scalpel or bipolar coagulation Postoperative: - Patients with ≥ 10 axillary nodes removed EXCLUSION CRITERIA Preoperative: * Mastectomy * Previous radiation therapy * Previous axillary emptying * Liver pathology * Diabetic decompensation: defined as any episode that has required medical attention in an emergency service or hospital admission; and also that which has required a modification of the patient's drugs, or an increase of more than 20% of the total daily dose. * Known allergies to any component of Hemopatch (proteins of bovine origin or PEG) * Psychiatric disorder that conditions the non-understanding of the questionnaire, or incapacitation of the patient to understand it * Simultaneous participation in another clinical study * PCR positive for SARS-CoV-2 Intraoperative: * Level 3 axillary dissection (severe axillary involvement) * Unexpected surgical contraindication * Hemostasis and lymphostasis: ultrasonic techniques or other advanced energy techniques are excluded. * Use of fibrin sealants (eg: Tisseel, Artiss, Tachosil), cyanoacrylate type adhesives (eg: Glubran-2) or other types of products (oxidized cellulose format, powders or gelatin sheets or collagen).
Where it's running
-
General Surgery and Digestive System Service
Toledo, Spain Recruiting
Study contacts
- Study coordinator: María García Ávila, MD
- Email: garciaavilamaria@gmail.com
- Phone: 638432910
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.