| CTRI Number |
CTRI/2022/06/042968 [Registered on: 02/06/2022] Trial Registered Prospectively |
| Last Modified On: |
02/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of infrared thermography in assessing skin vasularity |
|
Scientific Title of Study
|
Role of infrared thermography in evaluating vascularity of degloved skin in traumatic injuries and in post-operative flap monitoring |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanak Singla |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Room no 403, 4th floor, A block, AIIMS OPD
Room no 403, 4th floor, A block, AIIMS OPD
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8689011338 |
| Fax |
|
| Email |
singla.priyanka1710@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pawan K Dixit |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Room no 404, 4th floor, A block, AIIMS OPD
Room no 404, 4th floor, A block, AIIMS OPD
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7838770179 |
| Fax |
|
| Email |
sine.pkd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanak Singla |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Room no 403, 4th floor, A block, AIIMS OPD
Room no 403, 4th floor, A block, AIIMS OPD
Jodhpur
RAJASTHAN
342005
India |
| Phone |
|
| Fax |
|
| Email |
singla.priyanka1710@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Pawan K Dixit |
| Address |
Room no 404,OPD A Block, Department of Plastic Surgery, AIIMS Jodhpur |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Priyanka Singla |
AIIMS JODHPUR |
Dept. of plastic surgery, AIIMS JODHPUR
Jodhpur
RAJASTHAN |
8689011338
singla.priyanka1710@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, AIIMS Jodhpure |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C768||Malignant neoplasm of other specified ill-defined sites, (2) ICD-10 Condition: T148||Other injury of unspecified body region, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Infrared thermal camera |
Infrared thermal camera is a objective means of documenting viability of skin by taking pictures |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of any age group undergoing free flap reconstruction of any defect
2. Patients of any age group presenting with degloving injuries within 24 hours |
|
| ExclusionCriteria |
| Details |
1. Patients in whom no skin paddle is available for monitoring
2. Patients in whom skin paddle is not accessible for monitoring
3. Refusal to give consent to participate in the study
4. Patients presenting after 24 hours
5. Post traumatic patients who are unstable presenting with shock
6. Patient presenting with crushing injuries with skin loss |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing viability of degloved skin or free flaps using infrared thermography |
1. On day 1, 2, 3 for de-gloving injuries
2. Intra-operative and Post-operative day 1 to 5 for free flap monitoring |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing the utility of infrared thermography for degloving injuries and free flap monitoring |
After study ends |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
02/06/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective experimental study to evaluate the role of infrared thermography in degloving injuries and post-operative flap monitoring. The final outcome will be to compare results of infrared thermography with clinical assessments in identifying skin viability in degloving injuries and to evaluate its role in post-operative free flap monitoring, comparing it with gold standard clinical assessment. It will include all the stable patients presenting within 24 hours of degloving injuries and patients undergoing free flap reconstruction of any type of defect. The data of degloving injury arm will be collected for three days and that of flap monitoring arm will be collected for 5 days post-operatively. This will help in establishing the role of infrared thermography (if any) for assessing skin vascularity in both degloving injuries and flap monitoring and possible early decision making |