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

May 14, 2015 updated by: Apichai Angspatt, Chulalongkorn University
The use of NPWT as a post-operative dressing significantly reduces the incidence of seroma formation after harvesting LD flap.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Locally advanced cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NPWT group
Negative pressure wound therapy was used to prevent donor site seroma formation
Device: The negative pressure wound therapy
Other Names:
  • NPWT
No Intervention: Control group
Conventional method was used to the donor site

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of seroma
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Aspirated Volume
Time Frame: 3 months
3 months
Frequency of Aspiration
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Collaborators

Thana Laopiyasakul
Pornthep Pungrasmi
Poonpissamai Suwajo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 10, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Estimate)

May 15, 2015

Last Update Submitted That Met QC Criteria

May 14, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 030/55

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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