Clinical Trials Logo
  1. Home
  2. Seroma
  3. NCT05901064

Evaluation of Ultrasonic Scissors and Diathermy for Axillary Clearance in Breast Cancer Patients — SEROM  

Seroma Clinical Trial

Official title:
Economic Comparison Between the Use of Ultrasonic Scissors and Diathermy for Axillary Clearance in Breast Cancer Patients

Clinical Trial Summary

Breast surgery plays an important role in the treatment of breast cancer. This study investigates if the use of Harmonic Focus has advantages than the use of conventional diathermy in axillary clearance due to metastatic breast cancer.

Clinical Trial Description

Breast surgery plays an important role in the treatment of breast cancer. Sometimes cancer cells can spread to lymph nodes in the axill. The first lymph node affected in the armpit is called the sentinel node. Surgery to remove this node can answer the question of whether the cancer has spread to the axill. If the node is affected, further surgery is performed to remove most of the lymph nodes in the armpit, a so-called axillary clereance. The breast unit at Linköping University Hospital performs about 60 axillary clereance per year. Axillary clereance is associated with a number of complications, such as infections, bleeding, pain, loss of sensation and limited mobility in the arm. Accumulation of wound fluid in the surgical area is common, affecting about a quarter of patients undergoing surgery. Small amounts of wound fluid usually do not require treatment, but larger accumulations usually require drainage. Patients who have symptoms from armpit wound fluid have to make repeated return visits so that a nurse drains the fluid using a needle. This poses several risks to the patient such as infection and/or bleeding. This, in turn, can delay the start of additional treatment and can put a financial burden on both the patient and the healthcare system. Today, the investigators use a device with a weak electric current (diathermy) to remove lymph nodes from the armpit. Harmonic Focus ® is a pair of scissors that instead uses ultrasound waves to divide the tissue. There are scientific studies showing that the use of ultrasonic scissors reduces the risk of fluid accumulation and thus the risk of complications after surgery[1, 2]. The investigators want to conduct a prospective study, an economic analysis comparing the costs of using diathermy versus Harmonic Focus®. In addition, patients will complete a quality of life questionnaire before surgery, approximately 4-6 weeks after and one year after surgery. The results of the questionnaires will be compared between the Harmonic Focus® and the diathermy group. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05901064
Study type Interventional
Source University Hospital, Linkoeping
Contact
Status Recruiting
Phase N/A
Start date January 21, 2021
Completion date December 31, 2025
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04496180 - Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy N/A
Completed NCT03665883 - Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia N/A
Completed NCT03650868 - The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery N/A
Completed NCT02668588 - Extended-release of Octreotide (LF-PB) for the Treatment of Seroma Phase 2
Completed NCT01454713 - Retrospective Analysis of Veritas in Breast Reconstruction N/A
Not yet recruiting NCT04471142 - Effectiveness of Compressive Bandage Use in Seroma Prevention N/A
Not yet recruiting NCT02967627 - VAC Dressings for Colorectal Resections N/A
Recruiting NCT03598712 - Local Compression Seroma DIminution Objective (CLODIS) Phase 3
Completed NCT04666051 - Fibrin Glue in Inguinal Lymphadenectomy N/A
Recruiting NCT01454167 - Acid Base and Electrolytes Patterns in Drains Operational Wounds and Its Relation to Complications N/A
Completed NCT01112735 - Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty Phase 2
Completed NCT00968318 - Excision of Strip of Deep Fascia to Reduce Seroma Formation and Extrusion of Tissue Expanders N/A
Completed NCT03647930 - The Effect of Arista on Post-Operative Bleeding and Wound Drainage Following Mastectomy N/A
Recruiting NCT05509829 - EvaLuating negAtive pressUre Wound theRapy in brEast coNserving Surgery N/A
Terminated NCT04818580 - Progressive Tension Sutures in Gender Affirming Mastectomy N/A
Withdrawn NCT02568085 - Trial Evaluating Use of Arista in Total Thyroidectomy N/A
Active, not recruiting NCT01942707 - Scarpa´s Fascia in the Formation of Seroma Post Abdominoplasty After Bariatric Surgery N/A
Recruiting NCT03167944 - Traditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy N/A
Recruiting NCT03190876 - Seroma Prevention After Body Contouring Procedures N/A
Completed NCT03590704 - Safety of the Use of Compressive Taping in Seroma N/A