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CTRI Number  CTRI/2026/01/102111 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 25/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Scooped Curette for daily debridement and dressing 
Scientific Title of Study   A Scopped Curette for Daily Wound Debridement and Dressing of Ulcers. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Guna Sahithi lebaka 
Designation  Post graduate, general surgery 
Affiliation  Saveetha medical college and hospital  
Address  Saveetha medical college and hospital,Thandalam,Kancheepuram district

Chennai
TAMIL NADU
602105
India 
Phone  9676237314  
Fax    
Email  Sahithireddy2196@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh S 
Designation  Professor 
Affiliation  Saveetha medical college and hospital  
Address  Saveetha medical college and hospital,Thandalam,Kancheepuram district

Chennai
TAMIL NADU
602105
India 
Phone  8072425914  
Fax    
Email  drrajeshs80@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Guna Sahithi lebaka 
Designation  Post graduate, general surgery 
Affiliation  Saveetha medical college and hospital  
Address  Saveetha medical college and hospital,Thandalam,Kancheepuram district

Chennai
TAMIL NADU
602105
India 
Phone  9676237314  
Fax    
Email  Sahithireddy2196@gmail.com  
 
Source of Monetary or Material Support  
Saveetha medical college and hospital, saveetha nagar,Thandalam,Chennai,Tamil Nadu, India,602105 
 
Primary Sponsor  
Name  Saveetha medical college and hospital  
Address  Saveetha medical college and hospital, saveetha nagar,Thandalam,Chennai,Tamil Nadu, India,602105 
Type of Sponsor  Private 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 
DrGuna Sahithi lebaka  Saveetha medical college and hospital   Saveetha medical college and hospital ,saveetha nagar, thandalam, Chennai-602105.
Chennai
TAMIL NADU 		 9676237314

Sahithireddy2196@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha medical college and hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  scooped curette used for daily wound debridement  Daily wound debridement was performed using a scooped curette under aseptic precautions to remove devitalized tissue while preserving healthy granulation tissue. Duration 4 weeks Comparator:Standard wound care Standard wound care consists of routine wound cleansing with normal saline, dressing changes as per institutional protocol, infection control measures, offloading when required, and medical management of comorbid conditions. No scheduled daily sharp mechanical debridement using a scooped curette is performed as part of standard wound care. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adults aged 18 years and above.
Patients with chronic non healing wounds of more than four weeks duration.
Wounds requiring regular mechanical debridement as part of standard wound care.
Wound etiologies including diabetic foot ulcers venous leg ulcers pressure ulcers post traumatic or post surgical wounds.
Wound size within a manageable range suitable for bedside debridement.
Patients who are willing to undergo daily wound debridement using a scooped curette.
Patients who are able to comply with daily wound care and follow up.
Patients who provide written informed consent. 
 
ExclusionCriteria 
Details  Critical limb ischemia, uncontrolled infection or sepsis, bleeding disorders or anticoagulation, malignant wounds, exposed bone/tendon/vessels, stable dry gangrene, severe pain intolerance, poor general condition, immunocompromised state, pregnancy, and inability to comply with follow-up 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effectiveness of wound debridement
Time to achieve a clean wound bed
Change in wound size 		 Percentage reduction in wound area — assessed at 2, 4, and 6 weeks
Time to complete wound bed granulation — within 4 weeks
Time to readiness for definitive closure (grafting/secondary healing) — within 6 weeks
Incidence of procedure-related complications (bleeding, infection, pain) — monitored throughout the study period (up to 6 weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
Bleeding during debridement (minimal / moderate / significant).
Pain during procedure, assessed using Visual Analog Scale (VAS).
Ease of debridement, as perceived by the operating surgeon.
Need for definitive wound coverage (SSG, flap, secondary closure).
Complications, if any (infection, excessive bleeding). 		 Baseline (Day 0)
Wound size, wound bed characteristics (slough, necrosis, granulation).
Daily assessment
Post-debridement wound bed status
Bleeding and pain during procedure
Day 7
Percentage of granulation tissue
Change in wound area
Day 14
Clean wound bed status
Readiness for definitive coverage
End of intervention
When wound becomes suitable for closure or grafting
Final wound measurements 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   06/02/2026 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 -  Statistical Analysis Plan

  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 [Sahithireddy2196@gmail.com].

  6. For how long will this data be available start date provided 19-01-2026 and end date provided 01-03-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is designed to evaluate the effectiveness and safety of daily wound debridement using a scooped curette in patients with chronic non healing wounds. The primary purpose of the study is to assess the time taken to achieve a clean wound bed with healthy granulation tissue following regular mechanical debridement. The study also aims to observe changes in wound size and wound bed characteristics during the treatment period. It is hypothesized that daily debridement using a scooped curette facilitates faster removal of devitalized tissue promotes healthy granulation tissue formation and prepares the wound earlier for definitive closure when compared to standard wound care practices. 
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