| CTRI Number |
CTRI/2019/08/020572 [Registered on: 06/08/2019] Trial Registered Prospectively |
| Last Modified On: |
07/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the efficacy of amniotic membrane as a wound dressing in patients with large wound following trauma. |
|
Scientific Title of Study
|
To study the efficacy of amniotic membrane as an alternative wound dressing in patients with large posttraumatic raw area at level 1 Trauma Center†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ABHINAV KUMAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS, ND |
| Address |
ROOM NO: 217. DIVISION OF TRAUMA SURGERY. DEPARTMENT OF SURGICAL DISCIPLINES. JPNATC, AIIMS. ND.
South
DELHI
110029
India |
| Phone |
9311157766 |
| Fax |
|
| Email |
drabhinav1975@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ABHINAV KUMAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS, ND |
| Address |
ROOM NO: 217. DIVISION OF TRAUMA SURGERY. DEPARTMENT OF SURGICAL DISCIPLINES. JPNATC, AIIMS. ND.
South
DELHI
110029
India |
| Phone |
9311157766 |
| Fax |
|
| Email |
drabhinav1975@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ABHINAV KUMAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS, ND |
| Address |
ROOM NO: 217. DIVISION OF TRAUMA SURGERY. DEPARTMENT OF SURGICAL DISCIPLINES. JPNATC, AIIMS. ND.
South
DELHI
110029
India |
| Phone |
9311157766 |
| Fax |
|
| Email |
drabhinav1975@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTE GRANT RESEARCH, AIIMS, ND. |
|
|
Primary Sponsor
|
| Name |
INSTITUTE RESEARCH GRANT |
| Address |
RESEARCH SECTION
AIIMS ND |
| Type of Sponsor |
Government funding agency |
|
|
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 ABHINAV KUMAR |
JPNATC AIIMS |
Room NO:217, DIVISION OF TRAUMA SURGERY. DEPARTMENT OF SURGICAL DISCIPLINES.
South
DELHI |
9311157766
drabhinav1975@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
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
In group I (control group) |
patients with large posttraumatic raw area will be treated with the conventional wound dressing which will be changed daily and assessed till the wound is ready for grafting or flap cover. |
| Intervention |
In the Group II amniotic membrane (AM) |
Patients with large posttraumatic area, amniotic membrane (AM) dressing will be used and held in place with a secondary dressing. Only the secondary dressing will be changed daily. The post traumatic raw area will be assessed by Bates Jensen Wound assessment tool and the photo documentation will done. The time frame will initial baseline ie one day one then on 7th, 14th and 28th day of the treatment period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who require wound dressing for external superficial wounds following trauma having the wound dimension of 10x10cm or more, till the period requiring definitive coverage ie skin grafting or the flaps cover. |
|
| ExclusionCriteria |
| Details |
1.Infected wounds
2.Deep wounds & internal wounds.
3.Open fractures
4.Known cases of Diabetes Mellitus.
5.A skin disorder that is chronic or currently active and involves the areas to be examined in this trial.
6.Patients who are immune-compromised.
7.Patients on steroids.
8.Pregnancy or lactation
9.Liver enzymes raised to twice the normal range
10.Serum creatinine > 1.4 mg %
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Early wound bed preparation for skin grafting in large post traumatic raw area by Bates Jensen Wound Assessment Tool and photo documentation |
Time Frame: Baseline , 7th , 14th , 28th day of treatment period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Incidence of (hypo- or hyper-) pigmentation, contracture and scar formation
2.Any incidence of wound complications ( e.g. discharge , inflammation , infection )
3.Pain assessment with Visual Analog Scale.
4.Any adverse events
|
Time Frame: Baseline , 7th , 14th , 28th day of treatment period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
08/08/2019 |
| Date of Study Completion (India) |
24/02/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
1. Reliability of the Bates-Jensen wound assessment tool for pressure injury assessment: The pressure ulcer detection study. Bates-Jensen B et al Wound Repair Regen. 2019 Jul;27(4):386-395.
2. Decellularized amnion scaffold with activated PRP: A new paradigm dressing material for burn wound healing. Kshersagar J, et al Cell Tissue Bank. 2018 Sep;19(3):423-436.
3. Amniotic Membrane Adjuncts & Clinical Applications in Wound Healing:A Review of the Literature. Kogan S, et al Wounds. 2018 Jun;30(6):168-173.
4. Treatment of acute ocular chemical burns. Sharma N et al Ophthalmol. 2018 Mar - Apr;63(2):214-235.
5. Efficacy and Time Sensitivity of Amniotic Membrane treatment in Patients with Diabetic Foot Ulcers: A Systematic Review and Meta-analysis. Laurent I, et al Diabetes Ther. 2017 Oct;8(5):967-979.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A randomized pilot study to evaluate the efficacy of amniotic membrane as an alternative wound dressing in patients with large posttraumatic raw area at level 1 Trauma Center. This is an open label , pilot study to assess the efficacy of amniotic membrane as a wound dressing. It will be tested in patients with large post traumatic raw area requiring coverage with skin grafts or flaps, which needs an appropriate wound dressing till the wound bed is ready for grafting or flap cover. Patients will be randomized in two groups using sealed envelope method. In group I (control group) patients will be treated with the conventional wound dressing. In the Group II amniotic membrane (AM) dressing will be used. The wound will be observed for healing and any signs of infection. In both the group patients the post traumatic raw area will be assessed by Bates Jensen Wound assessment tool and the photo documentation will be done. The time frame will initial baseline ie one day one then on 7th, 14th and 28th day of the treatment period. During this treatment period assessment of pain will also be done with Visual analog scale. Primary and secondary outcome measures will be noted and analyzed. Placenta will be obtained from the patient undergoing an elective caesarian section and willing for a repeat serological test after 3month.The donor blood serological test will be performed and the placenta will be used only if the serological test will be negative for HIV, Hepatitis B and C and VDRL at baseline. Placenta will be collected in a sterile storage container containing transport media and it will be transported to Stem Cell Facility (DBT Center of Excellence for Stem Cell Research), CTC, AIIMS. At this facility, amniotic membrane will be processed and be stored at –80° c in deep freezer for further use as per the requirement. For transfer to the patient, the amniotic membrane will be applied on large post traumatic raw in patient admitted in trauma surgery unit, to prepare the wound bed for early grafting or flap cover. The need for advanced dressing or allograft can be avoided by this strategy.
|