Autologous Fat Graft Alleviate Scar Pain

Scar Clinical Trial

Official title:

Alleviation of Neuropathic Scar Pain With Autologous Fat Graft

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01970761
• Other study ID #: KMUH-IRB-20120246
• Status: Completed
• Phase: N/A
• First received: October 23, 2013
• Last updated: October 23, 2013
• Start date: February 2008
• Est. completion date: April 2013

Study information

• Verified date: December 2012
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Scar

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung City

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS)		preoperatively and postoperatively after 1 week, 4 weeks, and 24 weeks.	No
Secondary	Neuropathic Pain Symptom Inventory (NPSI)		preoperatively and postoperatively after 1 week, 4 weeks, and 24 weeks	No