NCT01970761

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 28, 2013

Completed
Last Updated

October 28, 2013

Status Verified

December 1, 2012

Enrollment Period

4.9 years

First QC Date

October 23, 2013

Last Update Submit

October 23, 2013

Conditions

Scar

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale (VAS)

    preoperatively and postoperatively after 1 week, 4 weeks, and 24 weeks.

Secondary Outcomes (1)

  • Neuropathic Pain Symptom Inventory (NPSI)

    preoperatively and postoperatively after 1 week, 4 weeks, and 24 weeks

Study Arms (1)

scar, Fat Graft, Visual Analogue Scale

patients received autologous fat grafting in scar areas

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients received autologous fat grafting in scar areas

You may qualify if:

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

You may not qualify if:

  • patients refused to participate the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 80708, Taiwan

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2013

First Posted

October 28, 2013

Study Start

February 1, 2008

Primary Completion

January 1, 2013

Study Completion

April 1, 2013

Last Updated

October 28, 2013

Record last verified: 2012-12

Locations

TW(1)