Clinical trial NCT04904653: The Effectiveness of Hemopatch® in the Reduction of Post-surgical Serous Drainage
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hemopatch
Breast Cancer
Axillary Lymphadenectomy
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Asociación De Cirujanos De Mama De Toledo
First posted: 2021-05-27
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After axillary node dissection, patients will be randomised to:

* Hemopatch Group: Hemopatch (hemostatic device and surgical sealant) + suction drainage
* Control group: no sealant (liquid, gel or patch) + suction drain
Primary purpose: OTHER

Brief summary: 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.


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).

Primary outcomes:
measure: Total volume in milliliters (ml) of drainage
timeFrame: In the last 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: General Surgery and Digestive System Service
Study officials:
References: