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CTRI Number  CTRI/2018/09/015664 [Registered on: 10/09/2018] Trial Registered Prospectively
Last Modified On: 08/09/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of 2 types of skin sutures techniques in hip replacement surgery  
Scientific Title of Study   Comparison of 2 skin closure techniques in primary total Hip Arthroplasty Surgery  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rahul Suna 
Designation  fellow in arthroplasty  
Affiliation  sunshine hospitals  
Address  PG Road, Paradise, Sappu Bagh Apaprtment, Jogani, Ramgopalpet, Secunderabad.

Hyderabad
ANDHRA PRADESH
500003
India 
Phone  9885547187  
Fax    
Email  drsunarahul@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rahul Suna 
Designation  fellow in arthroplasty  
Affiliation  sunshine hospitals  
Address  PG Road, Paradise, Sappu Bagh Apaprtment, Jogani, Ramgopalpet, Secunderabad.

Hyderabad
ANDHRA PRADESH
500003
India 
Phone  9885547187  
Fax    
Email  drsunarahul@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rahul Suna 
Designation  fellow in arthroplasty  
Affiliation  sunshine hospitals  
Address  PG Road, Paradise, Sappu Bagh Apaprtment, Jogani, Ramgopalpet, Secunderabad.

Hyderabad
ANDHRA PRADESH
500003
India 
Phone  9885547187  
Fax    
Email  drsunarahul@gmail.com  
 
Source of Monetary or Material Support  
SUNSHINE HOSPITAL SECUNDERABAD 
 
Primary Sponsor  
Name  sunshine hospital 
Address  PG Road, Opposite Parsi Dharamsala, Paradise, Secunderabad, Telangana 500003 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR RAHUL SUNA  SUNSHINE HOSPITAL  Room no 1,department of orthopaedics, ARTHROPLASTY DIVISION , PG Road, Opposite Parsi Dharamsala, Paradise, Secunderabad, Telangana 500003
Hyderabad
ANDHRA PRADESH 		 9885547187

drsunarahul@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE SUNSHINE HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L76-L76||Intraoperative and postprocedural complications of skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1) primary THR patients only
2) aged more than 18years through posterolateral approach .  
 
ExclusionCriteria 
Details  1) revision thr patients
2) history of keloid scar formation;
3) long-term of corticosteroid use;
4) uncontrolled diabetes;
5) previous hip surgery;
6) malignancy;
7) developmental dysplasia of hip (DDH);
8) connective tissue disease including rheumatoid arthritis (RA), systemic lupus erythematous (SLE), psoriatic arthritis (PA);
9) other diseases or conditions known to affect wound healing. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The surgical site infections (SSIs) rate and patient’s satisfaction were evaluated with Hollander wound evaluation score (HWES) and VAS score .  6WEEKS AND 3MONTHS  
 
Secondary Outcome  
Outcome  TimePoints 
Patient’s satisfaction were evaluated with Hollander wound evaluation score (HWES) and VAS score .  1 YEAR 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   15/09/2018 
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="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   A prospective randomised comparison of 2 skin closure techniques in primary total hip arthroplasty surgery.HIP INERNATIONAL JOURNAL JAN 2018 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   primary purpose to compare the clinical outcome and patient satisfaction between 2 skin suture techniques metallic staples and subcuticular suture techniques
 
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