Role of Negative Pressure Wound Therapy in Latissimus Dor... | NCT02442401

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

NCT02442401

Sponsor

Chulalongkorn University

Status

Completed

Last Update Posted

May 15, 2015Estimated

Enrollment

40Actual

Phase

Phase 1

Conditions

NPWT
Latissimus Dorsi Flap
Breast Reconstruction

Interventions

The negative pressure wound therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

May 10, 2015

First Submission Date that Met QC Criteria

May 12, 2015

First Posted Date

May 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2015

Last Update Posted Date

May 15, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Apichai Angspatt, Apichai Angspatt, Chulalongkorn UniversityPrincipal Investigator

Lead Sponsor

Chulalongkorn UniversityOTHER

Collaborators

Name	Class
Thana Laopiyasakul	UNKNOWN
Pornthep Pungrasmi	UNKNOWN
Poonpissamai Suwajo	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
The negative pressure wound therapy	Device		NPWT group	NPWT

Measure	Description	Time Frame
Incidence of seroma		3 months

Measure	Description	Time Frame
Aspirated Volume		3 months
Frequency of Aspiration		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Locally advanced cancer

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided