NCT02442401CompletedPhase 1
Role of Negative Pressure Wound Therapy in Latissimus Dorsi Flap Donor Site Seroma Prevention
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Chulalongkorn University
- Enrollment
- 40
- Primary Endpoint
- Incidence of seroma
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 20-60 years Underwent breast reconstruction with LD Flap
Exclusion Criteria
- •Locally advanced cancer
Arms & Interventions
NPWT group
Experimental
Negative pressure wound therapy was used to prevent donor site seroma formation
Intervention: The negative pressure wound therapy (Device)
Control group
No Intervention
Conventional method was used to the donor site
Outcomes
Primary Outcomes
Incidence of seroma
Time Frame: 3 months
Secondary Outcomes
- Frequency of Aspiration(3 months)
- Aspirated Volume(3 months)
Investigators
Apichai Angspatt
Apichai Angspatt
Chulalongkorn University
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