Clinical Trials Logo
  1. Home
  2. Seroma
  3. NCT02668588

Extended-release of Octreotide (LF-PB) for the Treatment of Seroma

Seroma Clinical Trial

Official title:
A Multicentre, Double Blind, Randomized Placebo Controlled Trial to Assess the Effect of LF-PB on Seroma Formation in Women With Breast Cancer Undergoing Axillary Lymph Node Dissection

Clinical Trial Summary

This is a multicentre, double blind, randomized placebo controlled trial to assess the effect of LF-PB on seroma formation in women with breast cancer undergoing Axillary Lymph Node Dissection (ALND).

Recruited patients will be randomly assigned to receive LF-PB 30 mg or placebo.

Clinical Trial Description

The study will randomize between 24 and 72 subjects that received an ALND. A staged adaptive design is employed with two intermediate analyses and a final analysis. The first interim analysis at 24 treated subjects (at least 12 in each group) and the second at 48 treated subjects (at least 24 in each group). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02668588
Study type Interventional
Source Chemi S.p.A.
Contact
Status Completed
Phase Phase 2
Start date October 22, 2015
Completion date July 19, 2016
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 NCT03650868 - The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery N/A
Completed NCT03665883 - Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia N/A
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
Recruiting NCT04035590 - Seroma Reduction and Drain Free Mastectomy N/A