| CTRI Number |
CTRI/2018/08/015186 [Registered on: 03/08/2018] Trial Registered Retrospectively |
| Last Modified On: |
05/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Role of facial fat grafting in trauma patients |
|
Scientific Title of Study
|
To evaluate Results of soft tissue reconstruction and augmentation with Structural fat grafting in patients with post traumatic facial disfigurement |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SR/WOS-A/LS-1444/2015(G) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchi Pathak Kaul |
| Designation |
Women Scientist Fellow |
| Affiliation |
JPN Apex Trauma Centre,AIIMS,New Delhi |
| Address |
Room no 306
Third floor
JPN Apex Trauma Centre
AIIMS
NEW DELHI
Room no 306
Third Floor
JPN Apex Trauma Centre
AIIMS,
New Delhi
New Delhi
DELHI
29
India |
| Phone |
9650777017 |
| Fax |
9650777017 |
| Email |
ruchi8380@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Pathak Kaul |
| Designation |
Women Scientist Fellow |
| Affiliation |
JPN Apex Trauma Centre,AIIMS,New Delhi |
| Address |
Room no 306
Third floor
JPN Apex Trauma Centre
AIIMS
New Delhi
Room no 306
Third Floor
JPN Apex Trauma Centre
AIIMS,
New Delhi
New Delhi
DELHI
29
India |
| Phone |
9650777017 |
| Fax |
9650777017 |
| Email |
ruchi8380@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchi Pathak Kaul |
| Designation |
Women Scientist Fellow |
| Affiliation |
JPN Apex Trauma Centre,AIIMS,New Delhi |
| Address |
House no 673
Sector 9
Faridabad
Room no 306
Third Floor
JPN Apex Trauma Centre
AIIMS,
New Delhi
Faridabad
HARYANA
121006
India |
| Phone |
9650777017 |
| Fax |
|
| Email |
ruchi8380@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Science & Technology,New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMSNEW DELHI |
| Address |
JPN Apex Trauma Centre
AIIMS,Ansari Nagar
New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ruchi Pathak Kaul |
JPN Apex Trauma Centre,AIIMS |
Room no 306,3rd floor
New Delhi
South
DELHI |
9650777017
ruchi8380@gmail.com |
| Dr Sushma Sagar |
JPN Apex Trauma Centre,AIIMS,New Delhi |
Professor
Division of Trauma Surgery and CriticalCare
Room no 306,3rd floor
South
DELHI |
9891510122
sagar.sushma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee,AIIMS, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S024||Fracture of malar, maxillary and zygoma bones, Post Traumatic facial defects, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autologous Fat |
Autologous fat taken from abdomen or thigh will be centrifuged and pure fat will be reinjected on facial defect of same patient.Amount of fat varies as per needed for defect fulfillment.On Face it ranges fro 4-12cc of injected fat after processing. |
| Comparator Agent |
Clinical Pictures-pre op,post op 3,6 mon post op
WHO QOL Scale pre,3mon,6 mon
VAS Scale |
In definite intervals Clinical pictures shall be taken.Patient has to answer a 25 questions questionnaire called as WHO QOL Scale at pre op,3 months post op and 6 months post op.Patient Satisfaction shall be measured on 0-10 VAS Scale. at 15 days ,3 mons and 6 mons |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient able to provide informed consent
2. Have suffered injury resulting in craniofacial volume defects
3. Post traumatic defect with oedema having subsided
4. Volume defects covered by intact skin but which do not communicate with oral cavity or sinuses
5. Asymmetrical defect on face with one side of normal contour to allow for lipoaspirate injection in order to attain symmetry.
6. Willing and able to comply with follow up examinations, including radiographic studies –ultrasonography
|
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years
2. Inability to provide informed consent
3. Craniofacial defects intended for treatment have open wounds or communicate with oral cavity or sinus
4. Active infection anywhere in the body
5. Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment
6. Known coagulopathy
7. Pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Facial Symmetry |
1year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
1year |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/02/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Application of facial fat grafting in Post Traumatic facial defects: Our Experience at a Level I Trauma Centre, AIIMS, New Delhi. Journal of Dental and Oral Health.
Autologous Fat Transfer and Scar Revision to Restore Contour Defects in Post-Operative Facial Trauma: A Less invasive and more Economical Method. The National Medical Journal of India. Volume 29, supplement 1, Pg. 70, 2016.
Can Mesenchymal Stem Cell be used as an Additive Therapeutic Procedure for Fracture Healing in Facial Injuries?? Journal of Dental and Oral Health J Dent Oral HealthVolume 2, Issue 4, e106
Can soft tissue reconstruction with structural fat grafting be used an alternative invasive surgical procedure in patients with post-traumatic facial defects? . Indian Journal of Immunology and Respiratory Medicine, April-June 2016; 1(2); 31-3 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Injuries to the maxillofacial region are increasing in frequency and severity because of the heavy reliance on road transportation and the increasing socio-economic activities of the population with road crashes being predominant cause of maxillofacial trauma.These injuries have devastating consequences in the quality of life of the injured. With this background, the study is planned to exploit the newer concepts of autologous fat transfer in trauma cases for reconstruction of facial defects.Facial rejuvenation with autologous fat has the advantage of replacing or augmenting tissue with like tissue.By conducting an evidence-based review, this report will offer a graded summary of the evidence to help optimize the clinical use of fat grafts.Overall, complication rates associated with fat grafting are not unduly high, considering the level of invasiveness of the procedure. Fat grafting can be considered a safe method of augmentation and correction of defects associated with various medical conditions.We hypothesize that autologous fat grafting is a promising procedure to recreate the lost soft tissue defect of post traumatic asymmetric face and improve themorbidity for the patient and improve the quality of life for the patient. |