Autologous Fat Graft Alleviate Scar Pain | NCT01970761

Studies
Autologous Fat Graft Alleviate Scar Pain

NCT01970761

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Status

Completed

Last Update Posted

Oct 28, 2013Estimated

Enrollment

36Actual

Phase

Not provided

Conditions

Scar

Interventions

Not provided

Countries

Taiwan

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

Dec 2012

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

Feb 2008

Primary Completion Date

Jan 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Oct 23, 2013

First Submission Date that Met QC Criteria

Oct 23, 2013

First Posted Date

Oct 28, 2013Estimated

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

Oct 23, 2013

Last Update Posted Date

Oct 28, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Traumatic wounds inflict small- and large-fiber sensory nerve damage, causing neuropathic pain in scar tissue. Autologous fat grafting has been clinically shown to improve scar quality, but scantly study has explored its effects on pain. The aim of the study was to survey its effect on pain.

Detailed Description

Methods: From February 2008 and June 2013, a total of 36 patients received autologous fat grafting in scar areas. Patients who Douleur Neuropathique 4 Questions (scores >4/10) were enrolled this study. The Visual Analogue Scale (VAS), and Neuropathic Pain Symptom Inventory (NPSI) were used to evaluate pain preoperatively and postoperatively after 1 week, 4 weeks, and 24 weeks. The mechanism of trauma, duration of allodynia, fat graft volume, and total follow-up time were recorded.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
scar, Fat Graft, Visual Analogue Scale		patients received autologous fat grafting in scar areas

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analogue Scale (VAS)		preoperatively and postoperatively after 1 week, 4 weeks, and 24 weeks.

Secondary Outcomes

Measure	Description	Time Frame
Neuropathic Pain Symptom Inventory (NPSI)		preoperatively and postoperatively after 1 week, 4 weeks, and 24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

February 2008 and June 2013, patients received autologous fat grafting in scar areas and also had pain over scar area before surgery

Exclusion Criteria:

patients refused to participate the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

patients received autologous fat grafting in scar areas

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
shu-hung huang, MD	Division of Plastic Surgery, Department of Surgery, Kaohsiung Medical University Hospital	Principal Investigator
Chung-Sheng Lai, PhD	Division of Plastic Surgery, Department of Surgery, Kaohsiung Medical University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Medical University Hospital		Kaohsiung City		80708	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D002921	Cicatrix

Ancestor Terms

ID	Term
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

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