Using Hemopatch to reduce fluid drainage after breast cancer surgery

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

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
• Enrollment: 118 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Instituto de Investigación Hospital Universitario La Paz (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Toledo)
• Trial ID: NCT04904653 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients who have undergone mastectomy or have previous radiation therapy or axillary emptying may not benefit from this study.

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 performed: 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.

Eligibility 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 this trial is running

Toledo

• General Surgery and Digestive System Service — Toledo, Spain (Recruiting)

Study contacts

• Study coordinator: María García Ávila, MD

Conditions Hemopatch; Breast Cancer; Axillary Lymphadenectomy