| CTRI Number |
CTRI/2024/09/073315 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of maxillofacial soft tissue traumatic injuries using Nanocrystalline Silver dressing |
|
Scientific Title of Study
|
Evaluation of the role of nanocrystalline silver dressing
in healing of soft tissue injuries involving the
maxillofacial region- A Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dishari Basu |
| Designation |
Post Graduate Student |
| Affiliation |
SRM Dental College, Ramapuram |
| Address |
Department of Oral and Maxillofacial Surgery,
SRM Dental College,
Ramapuram
Chennai
TAMIL NADU
600089
India |
| Phone |
8779603021 |
| Fax |
|
| Email |
dbasu24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Elavenil Pannerselvam |
| Designation |
Professor |
| Affiliation |
SRM Dental College, Ramapuram |
| Address |
Department of Oral and Maxillofacial Surgery
SRM Dental College
Bharathi Salai, Ramapuram Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9841254653 |
| Fax |
|
| Email |
elavenilomfs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Elavenil Pannerselvam |
| Designation |
Professor |
| Affiliation |
SRM Dental College, Ramapuram |
| Address |
Department of Oral and Maxillofacial Surgery,
SRM Dental College
Bharathi Salai, Ramapuram Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9841254653 |
| Fax |
|
| Email |
elavenilomfs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral and Maxillofacial Surgery, SRM Dental College, Bharathi Salai, Ramapuram,
Chennai- 600089
Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Dr Dishari Basu |
| Address |
Department of Oral and Maxillofacial Surgery,
SRM Dental College,
Bharathi Salai, Ramapuram, Chennai- 600089
Tamil Nadu, India |
| 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 |
| Dr Dishari Basu |
SRM Dental College, Ramapuram |
Department Of Oral and
Maxillofacial Surgery
SRM Dental College,
Bharathi Salai,
Ramapuram
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
8779603021
dbasu24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Dental College Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-S09||Injuries to the head, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine Gauze dressing (Bactigras) |
Chlorhexidine Acetate (Bactigras) dressing will be cut to fit the to the size of the wound and placed over the injured area (abrasion/laceration over maxillofacial region). Dressing will be changed twice (3rd & 7th day) after placement on baseline day. Additional dressing will be given based on the
clinical needs (infection/discharge) |
| Intervention |
Nanocrystalline Silver dressing (Acticoat) |
Nanocrystalline silver dressing (Acticoat) material
will be cut to size as needed. Dressing will be moistened with sterile water. Moistened dressing patch will be placed over the injured area (abrasion/laceration of maxillofacial region) and secured using moisture retentive dressing material.
Dressing will be changed twice (3rd & 7th day) after initial placement on baseline day. Additional dressing will be given based on the clinical needs (infection/discharge). |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients indicated for management of soft tissue
injuries involving the maxillofacial region due to
impact/mechanical injuries.
2. Patients with soft tissue abrasion of size ranging
from 1cm to 5cm
3. Patients with soft tissue laceration not requiring
suturing and surgical wounds with dehiscence
4. Patients reporting within 24 hours of injury
5. Patients categorized under ASA status I & II |
|
| ExclusionCriteria |
| Details |
1. Patients aged below 20 years and above 50 years
2. Patients who are allergic to silver
3. Patients presenting with avulsive soft tissue
injury, animal bites, chemical injuries,
penetrating wounds, wounds with foreign bodies
and complex wounds involving vital structures
4. Patients with existing dermatological disorders
5. Patients belonging to ASA III, IV, V
6. Patients not willing to be a part of the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Healing (assessment of scar formation)
2. Pain |
1. Scar formation- 7th day, 14th day, 90th day
2. Pain- baseline day, 3rd day, 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Microbial load
2. Patient satisfaction |
1. Microbial load checked on 3rd and 7th day
2. Patient satisfaction on 3rd, 7th, 14th and 30th day |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 4 |
|
Date of First Enrollment (India)
|
05/11/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Soft tissue injuries of the face constitute one of the most
commonly encountered problems by maxillofacial
surgeons. These injuries present in the form of abrasion,
laceration or avulsion which may lead to severe cosmetic
and /or functional problems; cosmetic problems include
scars, uneven skin surface/dehiscence and hyper or hypo
pigmentation while functional problems include restricted
facial movements, infection, hemorrhage and nerve
damage. The conventional methods
of treating these injuries include betadine dressing,
chlorhexidine dressing, Framycetin sulfate dressing, tissue
adhesives, collagen dressing, foam dressing, hydrocolloid
dressing, suturing and the use of split/full skin graft.
However, these are associated with limitations in terms of
usage, clinical outcome, allergic reactions, patient
compliance and expense. The advantages of nanocrystalline silver dressing
are many; sustained release of non-ionic form of silver
which is tissue friendly and better antimicrobial efficiency.
There is negligible literature regarding the use of
nanocrytalline silver dressing for the management of facial
wounds due to mechanical trauma. Hence this study has
been designed to test the efficacy of nanocrystalline silver
dressing material in facilitating soft tissue healing
following trauma. |