Back to resultsRole of Negative Pressure Wound Therapy in Latissimus Dorsi Flap Donor Site Seroma Prevention
Primary Purpose
NPWT, Latissimus Dorsi Flap, Breast Reconstruction
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
The negative pressure wound therapy
Sponsored by
About this trial
This is an interventional prevention trial for NPWT
Eligibility Criteria
Inclusion Criteria:
- Age between 20-60 years Underwent breast reconstruction with LD Flap
Exclusion Criteria:
- Locally advanced cancer
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
NPWT group
Control group
Arm Description
Negative pressure wound therapy was used to prevent donor site seroma formation
Conventional method was used to the donor site
Outcomes
Primary Outcome Measures
Incidence of seroma
Secondary Outcome Measures
Aspirated Volume
Frequency of Aspiration
Full Information
NCT ID
NCT02442401
First Posted
May 10, 2015
Last Updated
May 14, 2015
Sponsor
Chulalongkorn University
Collaborators
Thana Laopiyasakul, Pornthep Pungrasmi, Poonpissamai Suwajo
1. Study Identification
Unique Protocol Identification Number
NCT02442401
Brief Title
Role of Negative Pressure Wound Therapy in Latissimus Dorsi Flap Donor Site Seroma Prevention
Official Title
Role of Negative Pressure Wound Therapy in Latissimus Dorsi Flap Donor Site Seroma Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
Collaborators
Thana Laopiyasakul, Pornthep Pungrasmi, Poonpissamai Suwajo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The use of NPWT as a post-operative dressing significantly reduces the incidence of seroma formation after harvesting LD flap.
Detailed Description
NPWT was left in place on donor site with constant pressure between -125 and -80 mmHg to reduce seroma formation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NPWT, Latissimus Dorsi Flap, Breast Reconstruction
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NPWT group
Arm Type
Experimental
Arm Description
Negative pressure wound therapy was used to prevent donor site seroma formation
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Conventional method was used to the donor site
Intervention Type
Device
Intervention Name(s)
The negative pressure wound therapy
Other Intervention Name(s)
NPWT
Primary Outcome Measure Information:
Title
Incidence of seroma
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Aspirated Volume
Time Frame
3 months
Title
Frequency of Aspiration
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 20-60 years Underwent breast reconstruction with LD Flap
Exclusion Criteria:
Locally advanced cancer
12. IPD Sharing Statement
Learn more about this trial
Role of Negative Pressure Wound Therapy in Latissimus Dorsi Flap Donor Site Seroma Prevention
We'll reach out to this number within 24 hrs