Clinical Trials Logo

Clinical Trial Summary

Study aim was to evaluate topical MPH on the risk of post-mastectomy seroma formation as measured by total drain output and total drain days.


Clinical Trial Description

Seroma formation is the most common complication after mastectomy and places patients at risk of associated morbidities. Microporous Polysaccharide Hemospheres (MPH) consists of hydrophilic, plant based, polysaccharide particles and is currently used as an absorbable hemostatic agent. An animal model evaluating MPH and seroma formation after mastectomy with axillary lymph node dissection showed a significant decrease in seroma volume. Study aim was to evaluate topical MPH on the risk of post-mastectomy seroma formation as measured by total drain output and total drain days.

Prospective randomized single-blinded clinical trial of patients undergoing mastectomy for the treatment of breast cancer. MPH was applied to the surgical site in the study group and no application in the control group.

Fifty patients were enrolled; eight were excluded due to missing data. Forty-two patients were evaluated, control (n=21) vs. MPH (n=21). No difference was identified between the two groups regarding demographics, tumor stage, total drain days, total drain output, number of clinic visits, or complication rates. On a subset analysis, body mass index (BMI) greater than 30 was identified as an independent risk factor for high drain output. Post hoc analyses of MPH controlling for BMI also revealed no statistical difference.

Unlike the data presented in an animal model, no difference was demonstrated in the duration and quantity of serosanguinous drainage related to the use of MPH in patients undergoing mastectomy for the treatment of breast cancer. BMI greater than 30 was identified as an independent risk factor for high drain output and this risk was not affected by MPH use. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03647930
Study type Interventional
Source Memorial Health University Medical Center
Contact
Status Completed
Phase N/A
Start date May 15, 2012
Completion date March 6, 2015

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
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