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CTRI Number  CTRI/2026/02/104112 [Registered on: 17/02/2026] Trial Registered Prospectively
Last Modified On: 12/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   study on the effect of derotation on perforator flaps challenged with vascular compromise  
Scientific Title of Study   A study on the effect of derotation on perforator flaps challenged with vascular compromise Randomised controlled 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  Shilpi Karmakar 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Room 403, 4th floor, A block, OPD, AIIMS, MIA phase2, Basni phase2

Jodhpur
RAJASTHAN
342005
India 
Phone  9628000023  
Fax    
Email  karmakars@aiimsjodhpur.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Shilpi Karmakar 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Room 403, 4th floor, A block, OPD, AIIMS, MIA phase2, Basni phase2

Jodhpur
RAJASTHAN
342005
India 
Phone  9628000023  
Fax    
Email  karmakars@aiimsjodhpur.edu.in  
 
Details of Contact Person
Public Query  
Name  Shilpi Karmakar 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Room 403, 4th floor, A block, OPD, AIIMS, MIA phase2, Basni phase2

Jodhpur
RAJASTHAN
342005
India 
Phone  9628000023  
Fax    
Email  karmakars@aiimsjodhpur.edu.in  
 
Source of Monetary or Material Support  
AIIMS, Basni phase 2, MIA phase 2, Jodhpur 342005, Rajasthan, India 
 
Primary Sponsor  
Name  AIIMS 
Address  Basni phase 2, MIA phase 2, Jodhpur 342005, Rajasthan, India 
Type of Sponsor  Government medical college 
 
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 Shilpi Karmakar  All India Institute of Medical Sciences, Jodhpur, India  Department of Burns and Plastic Surgery, OPD room no 403, AIIMS,Basni phase 2, MIA phase 2, Jodhpur- 342005
Jodhpur
RAJASTHAN 		 9628000023

karmakars@aiimsjodhpur.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS,Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L768||Other intraoperative and postprocedural complications of skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional treatment  Flaps challenged with vascular compromise are given Conventional treatment, like loosening the bandages, limb positioning, maintaining hydration of patient, maintaining warmth and preventing infection. 
Intervention  derotation of flap  Flaps challenged with vascular compromise are derotated as soon as vascular compromise is detected. The flap is rotated back to the surgical site, after 3 days. Meanwhile, all conventional treatment is continued, like loosening the bandages, limb positioning, maintaining hydration of patient, maintaining warmth and preventing infection. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  95.00 Year(s)
Gender  Both 
Details  Patients (or guardian) giving consent.
Perforator flap having vascular compromise.
 
 
ExclusionCriteria 
Details  Patients not willing for followup.
Mentally unstable patient.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Increase in surface area of flap at day 10, in those whom intervention is done along with conventional treatment.  day 10 after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Lesser need for secondary surgey, lesser morbidity, lesser pain, lesser hospital stay  Day 10 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   23/02/2026 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [karmakars@aiimsjodhpur.edu.in].

  6. For how long will this data be available start date provided 12-02-2026 and end date provided 11-02-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

The study will include all perforator flaps having vascular compromise. The vascular compromise will be detected by clinical methods- colour, temperature, turgor, bleeding pattern and measuring blood sugar of flap (using glucometer).

The flap will be randomised to group A or B by means of computer-generated table of random numbers.  Group A will get conventional measures, namely, removal of sutures and loosening of local dressing, increase of local temperature, limb elevation, oral antiplatelet drugs (aspirin 75 mg). Group B will get conventional measures, namely, removal of sutures and loosening of local dressing, increase of local temperature, limb elevation, oral antiplatelet drugs (aspirin 75 mg), along with derotation of the flap. After 3 days, the derotated flap will be rotated into the defect. All flaps will be monitored every 6 hourly by clinical methods- colour, temperature, turgor, bleeding pattern and measuring blood sugar of flap (using glucometer). The person allocating the groups and performing the monitoring will be different from the operating surgeon.

At the end of 10 days, the surviving surface area of the flap will be measured using measuring scale and software available at https://www.sketchandcalc.com/area-calculator-app/. This will be done by a person different from the operating surgeon.

All relevant data will be collected and entered in the proforma. The data will then be tabulated using MS-Excel spreadsheet and appropriate statistical analysis will be done. SPSS 23 will be used, wherever required.

 
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