NCT02442401

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
Last Updated

May 15, 2015

Status Verified

May 1, 2015

Enrollment Period

3.9 years

First QC Date

May 10, 2015

Last Update Submit

May 14, 2015

Conditions

NPWTLatissimus Dorsi FlapBreast Reconstruction

Outcome Measures

Primary Outcomes (1)

  • Incidence of seroma

    3 months

Secondary Outcomes (2)

  • Aspirated Volume

    3 months

  • Frequency of Aspiration

    3 months

Study Arms (2)

NPWT group

EXPERIMENTAL

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

Device: The negative pressure wound therapy

Control group

NO INTERVENTION

Conventional method was used to the donor site

Interventions

The negative pressure wound therapyDEVICE
Also known as: NPWT
NPWT group

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Locally advanced cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Apichai Angspatt

Study Record Dates

First Submitted

May 10, 2015

First Posted

May 13, 2015

Study Start

January 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 15, 2015

Record last verified: 2015-05