CTRI Number |
CTRI/2021/06/033978 [Registered on: 03/06/2021] Trial Registered Prospectively |
Last Modified On: |
01/06/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Other |
Public Title of Study
|
Subciliary approach for treatment of infraorbital bone fracture |
Scientific Title of Study
|
"EVALUATION OF EFFICACY OF SUBCILIARY APPROACH FOR THE TREATMENT OF INFRAORBITAL BONE FRACTURES-A CLINICAL STUDY" |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
kyamuna |
Designation |
post graduate |
Affiliation |
Government dental college and hospital , RIMS , kadapa |
Address |
27-154-2B,santhi colony
Ramnagar colony,chittoor
Department of oral and maxillofacial surgery,
GDCH ,RIMS,KADAPA Cuddapah ANDHRA PRADESH 517002 India |
Phone |
7981700437 |
Fax |
|
Email |
yamunayadavbds011@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Drkyamuna |
Designation |
post graduate |
Affiliation |
Government dental college and hospital , RIMS , kadapa |
Address |
Department of oral and maxillofacial surgery,
Government dental college and hospital,RIMS,Kadapa
Room no.8 , dental staff quarters, RIMS , kadapa Cuddapah ANDHRA PRADESH 516002 India |
Phone |
7981700437 |
Fax |
|
Email |
yamunayadavbds011@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DrDYesuratnam |
Designation |
Associate professor |
Affiliation |
Government dental college and hospital , RIMS , kadapa |
Address |
Department of oral and maxillofacial surgery,
Government dental college and hospital,RIMS,Kadapa Department of oral and maxillofacial surgery,
Government dental college and hospital,RIMS,Kadapa Cuddapah ANDHRA PRADESH 516002 India |
Phone |
08374082674 |
Fax |
|
Email |
yesuratnam.duddu@gmail.com |
|
Source of Monetary or Material Support
|
Government dental college and hospital,RIMS,kadapa |
|
Primary Sponsor
|
Name |
Government dental college and hospital |
Address |
RIMS,putlampalli
kadapa-516002 |
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 |
Drkyamuna |
Government dental college and hospital ,RIMS |
Department of oral and maxillofacial surgery,GDCH,RIMS,putlampalli
kadapa-516002 Cuddapah ANDHRA PRADESH |
7981700437
yamunayadavbds011@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Governmental dental college ,RIMS |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
NIL |
NIL |
Intervention |
Subciliary approach for reduction of infraorbital bone fracture |
Surgical incision is made 2mm inferior to the eyelashes, along the entire length of the lower eyelid, which can be extended laterally for additional exposure of the entire lateral orbital rim , followed by fixation of infraorbital bone fracture with titanium miniplate. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.patients with infraorbital bone fractures planned for open reduction and miniplate fixation.
2.patients between 18-60years of age.
3.patients free of significant systemic diseases[ASAI] and deemed fit for surgery by General physician.
4.Surgical site free of active infection. |
|
ExclusionCriteria |
Details |
1.Deemed medically unfit for surgery (ASA III & IV).
2.Hematological disorders.
3.Patient with soft tissue laceration of orbital region .
4.Patient with h/o keloid formation .
5.Scarophobic patients.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
presence of hypertrophic scar formation |
1week,1month,3months, |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.presence of postoperative scar formation.
2.presence of scleral show. |
1week,1month,3months |
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="10"
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)
|
14/06/2021 |
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="6" Days="20" |
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
|
The zygomatic bone is an essential element of facial configuration as it constitutes the prominence of the cheek bone. Because of its prominence and exposed location, the zygoma is highly susceptible to fractures in facial trauma. The zygoma is geometrically unique because it articulates with four bones - the frontal, temporal, maxilla and sphenoid. Zygoma fractures are typically described as being tetrapod. zygomatic complex fractures present challenging diagnostic and reconstructive problems for the surgeon. Anatomic reduction of lateral, inferior orbital rims and orbital floor are necessary to reestablish facial symmetry and position of the globe and to restore normal sensation to the structures innervated by the infraorbital nerve. The increasing emphasis on open reduction and bone grafting techniques in the treatment of facial fractures needs a search for incisions which provide good exposure of fracture sites and minimal cosmetic deformity. The lower orbital rim and orbital floor can be exposed transcutaneosly through the subciliary, subtarsal and infraorbital incisions or by means of transconjunctival incision with lateral canthotomy. The conventional subciliary incision which is a kind of transcutaneous incision was first described by converse in 1944. This approach spares the conjunctiva, bypasses the transconjunctival related complications, and eliminates the need for a lateral canthotomy. Furthermore the incision can be extended either to the medial or lateral sides to explore any associated fracture. In this study the following parameters are being studied: 1.Time duration of the surgery 2.presence of visible postoperative scar formation by using modified vancouver scar scale 3.presence of scleral show using ectropion grading scale |