| CTRI Number |
CTRI/2024/06/068433 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Photobiomodulation therapy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
RPhotobiomodulation therapy as an adjunct therapy in burn wound care |
|
Scientific Title of Study
|
Photobiomodulation therapy (PBMT) as an adjunct therapy for burn wound care in patients: A pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sujata Sarabahi |
| Designation |
Professor and HOD |
| Affiliation |
VMMC and Safdarjung Hospital, New Delhi |
| Address |
Department of Burns Plastic and Mxillofacial surgery, VMMC And Safdarjung Hospital , New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810054396 |
| Fax |
|
| Email |
drssarabahi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Sarabahi |
| Designation |
Professor and HOD |
| Affiliation |
VMMC and Safdarjung Hospital, New Delhi |
| Address |
Department of Burns Plastic and Mxillofacial surgery, VMMC And Safdarjung Hospital , New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810054396 |
| Fax |
|
| Email |
drssarabahi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suniti Kale |
| Designation |
Professor |
| Affiliation |
VMMC And Safdarjung Hospital , New Delhi |
| Address |
Department of Anaesthesia and Intensive Care,VMMC And Safdarjung Hospital , New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810287852 |
| Fax |
|
| Email |
findsuniti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Sujata Sarabahi |
VMMC and Safdarjung Hospital, New Delhi |
Plastic Surgery Office, Department of Burns, Plastic and Maxillofacial Surgery
New Delhi
DELHI |
9810054396
drssarabahi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VMMC AND Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T212||Burn of second degree of trunk, (2) ICD-10 Condition: T212||Burn of second degree of trunk, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Management of burn wound with standard of care treatment |
Patients having second degree superficial or deep dermal burns within 24 hours of injury, with TBSA involved (1-5 %).Standard of care treatment given. |
| Intervention |
Photobiomodulation therapy |
Patients having second degree superficial or deep dermal burns within 24 hours of injury, with TBSA involved (1-5 %). Treatment with laser- 810 nm/ 904 nm /
PBMT Combination
(pulsed 810 nm +( superpulsed 904 nm light) as Adjunct Therapy
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having second degree superficial or deep dermal burns within 24 hours of injury, with 1.TBSA involved (1-5 %) in the upper or lower limbs, chest, abdomen and back.
2.Aged between 18 to 65 years
3. Hemodynamically stable
4. Not taking medication for any ailment
|
|
| ExclusionCriteria |
| Details |
1. Presence of gangrene,
2. Pregnancy
3. Photosensitivity
4. Uncontrolled systemic disease
5. Chronic skin disease
6. Diagnosed uncontrolled mental illness, alcoholism or other addictions
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Time taken for epithelization/ appearance of granulation tissue |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pain : visual analog scale (VAS).
2. Biomarkers in serum: IL-1β, IL-6, TNF-α, Precalcitonin, CRP levels. (on 1st and last visit)
3. Pain markers – Substance P /COX2
4. Quality of Scar
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
16/06/2024 |
| Date of Study Completion (India) |
01/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
PBMT has been reported to accelerate healing and promote tissue repair in chronic wounds. A prospective , comparative , single center interventional study is proposed to be conducted at VMMC and Safdarjung hospital, New Delhi. All the patients coming to the department of burns , Plastic and reconstructive surgery, with thermal burns and meeting inclusion criteria will be considered as the study population. The study shall include 80 patients, with 20 patients in each group. 1. Study design; prospective interventional study 2. study period;3 months 3. Sample size; 80 patients 4. Venue:Department of Burns and Plastic Surgery, Dept of Anaesthesia, VMMC and SJH Patients with second degree superficial and deep burns within 24 hours of injury with TBSA involved (1-5%). Age between 18-65 years, hemodynamically stable will be included in the study. patients will be divided into 4 groups. Control sham group and 3 study groups. Patients will be managed with standard of care management with PBMT - pulsed 810nm light, 904 nm light, combination of the two. Time taken for epithelization / healing of wound will be noted
Study duration extended for another 6 months in view of inadequate number of recruitments the Study was completed on 01/04/2025
|