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CTRI Number  CTRI/2025/01/078979 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 19/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   to explore how Botox (botulinum toxin A) injections can help reduce the tightness and scarring that often happen after skin grafts or flap surgeries in people whose eyelids turn outward due to abnormal contraction 
Scientific Title of Study   Evaluation of botulinum toxin A effect on skin graft and flap contracture in cicatricial ectropion 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shivani Badgal 
Designation  Junior Resident 
Affiliation  PGIMER 
Address  Room no. 219, Department of Oculoplasty, Advanced Eye Centre PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8492857006  
Fax    
Email  Shivanibadgal9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manu Saini 
Designation  Assistant Professor  
Affiliation  PGIMER 
Address  Room no. 219, Dept of Oculoplasty, Advanced Eye Centre PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9999249626  
Fax    
Email  Manusaini1024@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manu Saini 
Designation  Assistant Professor  
Affiliation  PGIMER 
Address  Room no 219, Dept of Oculoplasty, Advanced Eye Centre PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9999249626  
Fax    
Email  Manusaini1024@gmail.com  
 
Source of Monetary or Material Support  
Thesis Grant, PGIMER, Chandigarh- 160012, India 
 
Primary Sponsor  
Name  Postgraduate Institute of Medical Education and Research  
Address  Research Foundation, Room no. 116, Advanced Eye Centre, Postgraduate institute of Medical Education and Research, Sector 12, Chandigarh- 160012, India. 
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 Shivani Badgal  Advanced Eye Centre  Room no 219, Dept of Oculoplasty, Advanced Eye Centre, Postgraduate institute of Medical Education and Research, Sector 12, Chandigarh
Chandigarh
CHANDIGARH 		 8492857006

shivanibadgal9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H021||Ectropion of eyelid,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Full thickness skin grafting + Botulinum Toxin A  0.15ml per cm of length of skin graft, once administered via subcutaneously beneath the graft intra-operatively after securing the graft over host bed. Only one injection will be given intra-operatively and effects will be evaluated on day 2, 7, 14 and 1 month and 6 weeks and 3 months 
Comparator Agent  Full thickness skin grafting alone  In patients of cicatricial ectropion, only full thickness skin grafting will be done 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patient presenting to oculoplastic clinic with cicatricial ectropion.
2. Patients with age more than 18 years.
3. Patients consenting for the use of BTX A.
4. Any grades of cicatricial ectropion severity. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Calculating mean deviation of parameters like Lid Lag, Lid contour, lid laxity, lid position, graft contracture, blink character.
2. Graft width with surface area using standardised photographs
3.Calculating standard deviation of all parameters. 		 day 2, 7, 14, 1 month, 6 weeks, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Lid lag, Lid laxity, Blink characters, Corneal erosions and Conjunctival congestion  3 months 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   01/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/02/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. 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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shivanibadgal9@gmail.com].

  6. For how long will this data be available start date provided 01-11-2025 and end date provided 01-11-2035?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Cicatricial ectropion is an acquired form of ectropion, characterized by vertical shortening and/or scarring of the anterior lamella of the eyelid. The definitive treatment of this condition often requires augmentation of the deficient anterior lamella with a full-thickness skin graft (FTSG). Despite its effectiveness, FTSG can result in post-surgical contracture during graft uptake. However, the treatment options for post-surgical contracture are not well-documented in the literature. Hence, this study is intended to mitigate post-surgical contracture following FTSG in cicatricial ectropion to improve the clinical outcomes. In the literature, botulinum toxin type A (BTX-A) has been noted to reduce de novo contracture and is widely used to minimize tension at surgical sites. However, there is limited literature on its role in preventing post-surgical contracture of FTSG. Only one animal study has evaluated the impact of BTX-A on wound healing and FTSG contracture, and no human studies have been conducted to date. Therefore, this study will be conducted to evaluate the efficacy of BTX-A in reducing FTSG contracture and enhancing clinical outcomes. 
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