Clinical trial · Interventional
The Effectiveness of Hemopatch® in the Reduction of Post-surgical Serous Drainage
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
- 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)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Axillary Lymphadenectomy | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hemopatch | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control group | Other | — | UNRESOLVED |
| Hemopatch | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hemopatch Group:
- description
- Hemopatch + suction drainage
- interventionNames
- Device: Hemopatch
- type
- OTHER
- label
- Control group
- description
- No sealant (liquid, gel or patch) + suction drain
- interventionNames
- Other: Control group
Primary outcomes (1)
- measure
- Total volume in milliliters (ml) of drainage
- timeFrame
- In the last 24 hours
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available