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

NCT ID: NCT02442401

Last Updated: 2015-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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

Conditions

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NPWT Latissimus Dorsi Flap Breast Reconstruction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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NPWT group

Negative pressure wound therapy was used to prevent donor site seroma formation

Group Type EXPERIMENTAL

The negative pressure wound therapy

Intervention Type DEVICE

Control group

Conventional method was used to the donor site

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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The negative pressure wound therapy

Intervention Type DEVICE

Other Intervention Names

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NPWT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Locally advanced cancer
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Thana Laopiyasakul

UNKNOWN

Sponsor Role collaborator

Pornthep Pungrasmi

UNKNOWN

Sponsor Role collaborator

Poonpissamai Suwajo

UNKNOWN

Sponsor Role collaborator

Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Apichai Angspatt

Apichai Angspatt

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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030/55

Identifier Type: -

Identifier Source: org_study_id

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