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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
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