Clinical Trials Logo
  1. Home
  2. Breast Reconstruction
  3. NCT02442401
  4. Details
NCT02442401 Clinical Trial

Role of Negative Pressure Wound Therapy in Latissimus Dorsi Flap Donor Site Seroma Prevention

Breast Reconstruction Clinical Trial

Official title:
Role of Negative Pressure Wound Therapy in Latissimus Dorsi Flap Donor Site Seroma Prevention

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02442401
Other study ID # 030/55
Secondary ID
Status Completed
Phase Phase 1
First received May 10, 2015
Last updated May 14, 2015
Start date January 2009
Est. completion date December 2012

Study information
Verified date May 2015
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority Thailand: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The use of NPWT as a post-operative dressing significantly reduces the incidence of seroma formation after harvesting LD flap.

Description:

NPWT was left in place on donor site with constant pressure between -125 and -80 mmHg to reduce seroma formation

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

- Age between 20-60 years Underwent breast reconstruction with LD Flap

Exclusion Criteria:

- Locally advanced cancer

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• The negative pressure wound therapy

Locations
Country Name City State
n/a

Sponsors (4)
Lead Sponsor Collaborator
Chulalongkorn University Poonpissamai Suwajo, Pornthep Pungrasmi, Thana Laopiyasakul

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of seroma 3 months No
Secondary Aspirated Volume 3 months No
Secondary Frequency of Aspiration 3 months No
See also
  Status Clinical Trial Phase
Recruiting NCT03757793 - Near-infrared Spectroscopy for Monitoring Tissue Oxygenation in Breast Reconstruction
Completed NCT05491473 - Negative Pressure in PAP Donor Sites
Not yet recruiting NCT06013514 - Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Completed NCT02169011 - Secondary Breast Reconstruction With a Flap of Skin From the Back N/A
Completed NCT01216319 - Evaluation of the Cook Biodesign Plastic Surgery Matrix N/A
Completed NCT01176786 - Reusable Versus Disposable Draping System in Breast Reconstruction Surgery N/A
Not yet recruiting NCT00973544 - Do Closed Suction Drains Affect the Complications Rate of Breast Reconstruction With Silicone Prosthesis? N/A
Active, not recruiting NCT00748722 - Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography N/A
Completed NCT00753922 - Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses Phase 3
Completed NCT05897463 - Nipple Neurotization
Recruiting NCT05377723 - Abdominal Scar Improvement in Microsurgical Breast Reconstruction N/A
Completed NCT04350411 - Comparison of PEAK PlasmaBlade™ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction N/A
Completed NCT06321549 - New Era of DIEP With Minimally Invasive Mastectomy
Withdrawn NCT03135392 - Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer N/A
Completed NCT01256502 - The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery N/A
Active, not recruiting NCT04715802 - Options on the Breast Reconstruction Timing and Method After Removal of Polyacrylamide Hydrogel
Active, not recruiting NCT04491591 - Implementing BREASTChoice Into Practice N/A
Recruiting NCT04661501 - BREAST ADM Trial for Alloplastic Breast Reconstruction N/A
Suspended NCT03625765 - Integrated Imaging System for In Vivo Visualization of Free Flap Perfusion Using Indocyanine Dye N/A
Withdrawn NCT00778947 - Single Centre Study to Compare Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer Breast Reconstruction N/A