- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01970761
Autologous Fat Graft Alleviate Scar Pain
October 23, 2013 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
Alleviation of Neuropathic Scar Pain With Autologous Fat Graft
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
36
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Kaohsiung City, Taiwan, 80708
- Kaohsiung Medical University Hospital
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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
19 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients received autologous fat grafting in scar areas
Description
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
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
Cohorts and Interventions
Group / Cohort |
|---|
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scar, Fat Graft, Visual Analogue Scale
patients received autologous fat grafting in scar areas
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Visual Analogue Scale (VAS)
Time Frame: preoperatively and postoperatively after 1 week, 4 weeks, and 24 weeks.
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preoperatively and postoperatively after 1 week, 4 weeks, and 24 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Neuropathic Pain Symptom Inventory (NPSI)
Time Frame: preoperatively and postoperatively after 1 week, 4 weeks, and 24 weeks
|
preoperatively and postoperatively after 1 week, 4 weeks, and 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: shu-hung huang, MD, Division of Plastic Surgery, Department of Surgery, Kaohsiung Medical University Hospital
- Study Chair: Chung-Sheng Lai, PhD, Division of Plastic Surgery, Department of Surgery, Kaohsiung Medical University Hospital
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
February 1, 2008
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
October 23, 2013
First Submitted That Met QC Criteria
October 23, 2013
First Posted (Estimate)
October 28, 2013
Study Record Updates
Last Update Posted (Estimate)
October 28, 2013
Last Update Submitted That Met QC Criteria
October 23, 2013
Last Verified
December 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- KMUH-IRB-20120246
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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