| CTRI Number |
CTRI/2021/01/030558 [Registered on: 19/01/2021] Trial Registered Prospectively |
| Last Modified On: |
18/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of use of human donor skin grafts in treating burn wounds. |
|
Scientific Title of Study
|
Evaluation of efficacy of human skin allografts in healing of partial thickness burn wounds. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gurlinka Srihari |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of General Surgery
3rd Floor
Smt. Sharadha Madhav Pai OPD Block
Kasturba Hospital
Manipal
Udupi District
Udupi KARNATAKA 576104 India |
| Phone |
8500816080 |
| Fax |
|
| Email |
gurlinka.hari11@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sreekumar N C |
| Designation |
Professor of Plastic Surgery |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Plastic Surgery
2nd Floor
Old OPD Block
Kasturba Hospital
Manipal
Udupi District
Udupi KARNATAKA 576104 India |
| Phone |
9809353454 |
| Fax |
|
| Email |
ncs.kumar@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Annappa Kudva |
| Designation |
Professor of Surgery |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of General Surgery
3rd Floor
Smt. Sharadha Madhav Pai OPD Block
Kasturba Hospital
Manipal
Udupi District
Udupi KARNATAKA 576104 India |
| Phone |
9448857394 |
| Fax |
|
| Email |
annappa.kudva@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Plastic Surgery, Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
Dr Annappa Kudva |
| Address |
Professor of Surgery
Department of General Surgery
3rd Floor
Smt. Sharadha Madhav Pai OPD Block
Kasturba Hospital, Manipal
Udupi District |
| Type of Sponsor |
Other [Investigator Initiated Study] |
|
|
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 Sreekumar NC |
Kasturba Hospital, Manipal |
Burns HDU
Ground Floor
Old IP Block
Kasturba Hospital
Manipal 576 104
Udupi KARNATAKA |
9809353454
ncs.kumar@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T300||Burn of unspecified body region, unspecified degree, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Partial thickness burns undergoing tangential excision (Debridement) and allografting of burn wounds after hemodynamic stability in the department of Plastic Surgery |
|
| ExclusionCriteria |
| Details |
1)Patients on Medications negatively affecting wound healing such as Corticosteroids, Chemotherapeutic agents.
2)Age > 75years, <1 year
3)Chemical induced Burns, Radiation Burns, Cold Burns, Immunocompromised patients and patient with collagen disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of human skin allograft in the wound healing of partial thickness burn wounds as a definitive dressing.
Wound is considered healing based on either of the following criteria
1.Peeling of allograft with evidence of epithelization of surface underneath.
2.Grafted area appears dry or the secretions from the grafted area are decreased when inspected on POD 4, POD 10, POD 15 and POD 21.
|
Upto POD 21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Allograft rejection and scar |
Upto 3 months after allograft application |
|
|
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)
|
25/01/2021 |
| 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="1" Months="4" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response (Others) - Peers involved in the manuscript review for publication and any regulatory authority
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - The data will be sent on written request by the Editor of the Journal or Head of the regulatory authority
- For how long will this data be available start date provided 25-01-2021 and end date provided 25-01-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Informed
consent will be obtained from all participants before enrolling into the study.
Data regarding time of sustainment of burns and cause of burns will be recorded.
Information regarding pre-existing illness/comorbidities will be collected. Alcohol
consumption and Tobacco usage history will be collected. Area of the burns is
measured using Modified Lund and Browder chart and Palmar method, and depth of
the wound will be mapped pictorially. Area of the Partial thickness burn wound
Allografted will be measured postoperatively. After allografting wound will be evaluated on POD 4, POD 10, POD 15 and POD 21
or on the day of discharge (which one of the either is the earliest) to look
for healing. Area of the wound taken up
for early Auto grafting, if the wound is considered non healing after Allografting,
will be measured and on which postoperative day after allografting the decision made by the treating unit and
the POD on which the wound is Autografted will be noted. Data regarding lab
parameters such as Haemoglobin, Serum electrolytes, Serum Total Proteins, Serum
albumin and Blood culture, wound culture sensitivity reports will be collected during
the course of study period. Body weight of the patient will be measured at the
time of admission and weekly after Allografting. Pain scoring will be done, from
age 10 yrs to 75 yrs, at the time of admission on POD 4, POD 10, POD 15 and POD
21 or on the day of discharge (which one of the either is the earliest). Data
regarding blood product transfusions, Albumin infusion and electrolyte
imbalance corrections (post Allografting) will be collected. Information
regarding the illness/Disease/comorbidities found on evaluation by the treating
unit during the course of study will be collected. Percentage area of the
allografted wound healed will be measured at the time of discharge. Feedback
will be collected on follow up regarding nature of scar after 1week, 1month,
2months, 3 months, after discharge. Statistics will
be provided at the end of study. |