| CTRI Number |
CTRI/2020/11/029284 [Registered on: 20/11/2020] Trial Registered Prospectively |
| Last Modified On: |
20/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Biocompatible & Biodegradable Polymeric Skin Grafts for Wounds |
|
Scientific Title of Study
|
A single center, open labeled, pilot study to evaluate the safety and efficacy of Poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV) nanofibrous synthetic biodegradable skin graft for full-thickness wounds |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SASTRA-PHBV-SKIN-01 Version 2 Dated 01/09/2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Binita Beck |
| Designation |
Consultant - Plastic Surgery |
| Affiliation |
Meenakshi Mission Hospital and Research Centre, Lake Area, Melur Road, Madurai |
| Address |
Department of Plastic Surgery,
Meenakshi Mission Hospital and Research Centre, Lake Area, Melur Road, Madurai
Madurai
TAMIL NADU
625107
India |
| Phone |
04522588741 |
| Fax |
04522586353 |
| Email |
drbinita23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Swaminathan |
| Designation |
Dean, Sponsored Research, Director, Centre for Nanotechnology & Advanced Biomaterials |
| Affiliation |
SASTRA Deemed University |
| Address |
Building Anusandhan Kendra 1, Floor 3, Department of Bioengineering, Room - ASK-1-403, Centre for Nanotechnology and Advanced Biomaterials (CeNTAB), Room 403
Thanjavur
TAMIL NADU
613401
India |
| Phone |
04362264220 |
| Fax |
04362264265 |
| Email |
swami@sastra.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Binita Beck |
| Designation |
Consultant - Plastic Surgery |
| Affiliation |
Meenakshi Mission Hospital and Research Centre, Lake Area, Melur Road, Madurai |
| Address |
Department of Plastic Surgery,
Meenakshi Mission Hospital and Research Centre, Lake Area, Melur Road, Madurai
Madurai
TAMIL NADU
625107
India |
| Phone |
04522588741 |
| Fax |
04522586353 |
| Email |
drbinita23@gmail.com |
|
|
Source of Monetary or Material Support
|
| SASTRA Deemed University, Tirumalaisamudram - 613401, Thanjavur, Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
SASTRA Deemed University |
| Address |
Tirumalaisamudram, Thanjavur - 613401 |
| Type of Sponsor |
Research institution |
|
|
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 Binita Beck |
Maduari Meenakshi Mission Hospital and Research Centre |
Room 101, Department of Plastic Surgery, Madurai Meenakshi Mission Hospital and Research Centre, Lake Area, Melur Road, Madurai 625107
Madurai
TAMIL NADU |
04522588741
04522586353
drbinita23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Madurai Meenakshi Mission Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T758||Other specified effects of external causes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV) nanofibrous synthetic biodegradable skin graft for full-thickness wounds |
The objective of the study is to investigate the safety and performance of Poly(3-
hydroxybutyrate-co-3-hydroxyvalerate) (PHBV) nanofibrous skin graft (EnScaff) to aid wound
healing. The treatment period of each subject will be 6 weeks and follow up period of 5 weeks. |
| Comparator Agent |
Single Arm Trial - Not Applicable |
Single Arm Trial - Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Males / females 18 or older
2. Patients with full-thickness traumatic wounds, surgical wounds, diabetic wounds, post-debridement wounds of 1 to 10 cm 2
3. Ulcer free of all necrotic and infected soft tissue (based on clinical investigator’s discretion).
4. Have no significant diseases or clinically significant abnormal laboratory values during screening
5. In case of diabetic subjects, with regular medical treatment for diabetes
6. Able to understand, communicate and sign the written informed consent form
7. Adequate hematology, biochemistry & urine laboratory values
|
|
| ExclusionCriteria |
| Details |
Any of the following is regarded as a criterion for exclusion from the study:
1. Patients showing impaired blood coagulation
2. Patients with hematopoietic, renal, immunological and dermatological diseases/disorders
3. History of psychiatric disorders
4. Recent history (< 2 years) of alcoholism (alcohol abuse) or unlikely to refrain from excessive alcohol consumption during the study period
5. Smokers, who smoke more than 10 cigarettes per day and cannot refrain from smoking during the study period
6. Use of any recreational drugs or a history of drug addiction
7. Participation in another trial within 30 days of enrollment for this study
8. Women who are pregnant or are breast feeding
9. Subjects with positive HIV, HBV and HCV
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The frequency and severity of all treatment-related adverse events, during and after use of PHBV nanofibrous scaffold will be examined throughout the follow-up period. Adverse events will be assessed on a continuous basis |
1 week, 2 weeks, 3 weeks, 4, weeks, 5 weeks and 6 weeks post-implantation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Wound closure |
The treatment period of each subject will be 6 weeks and follow up period of 5 weeks |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/12/2020 |
| 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="0"
Months="9"
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 - NO
|
|
Brief Summary
|
Traumatic wounds including surgical
wounds and diabetic ulcers are chronic and it causes a significant number of morbidities
worldwide. These wounds are often called as hard-to-heal wounds. None of the currently available marketed
biomaterials for skin replacements possess all the ideal requirements of a skin
graft. Despite the progress in wound
management strategies over the years, clinically available dermal substitutes
suffer from some pitfalls like undesirable wound contraction, scar formation,
poor angiogenesis and poor engraftment.
This fact necessitates the development of a safe, easy to handle and
cost-effective skin graft with better therapeutic efficacy. Biodegradable polymeric nanofibrous scaffolds
have been shown to be effective in accelerating full-thickness wounds. In this
proposed study, the potential of EnScaff in healing full-thickness wounds is to
be tested for the first time in a clinical setting. Participants in this study
will receive PHBV nanofibrous scaffolds (EnScaff) followed by regular observation for a period of 11
weeks.
|