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CTRI Number  CTRI/2025/04/084093 [Registered on: 04/04/2025] Trial Registered Prospectively
Last Modified On: 03/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial comparing wound healing and wound complications between standard of care dressing and negative pressure wound therapy in post-operative limb salvage surgery of bone tumours around the knee. 
Scientific Title of Study   Comparison between Negative Pressure Wound Therapy and Standard-of-Care in Post-operative wound healing and wound complications after limb salvage surgery in bone tumours. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shanborlang Siangshai 
Designation  Junior Resident Doctor 
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Orthopaedics, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Chandigarh, Sector 12, India.

Chandigarh
CHANDIGARH
160012
India 
Phone  7760581037  
Fax    
Email  shanbor329@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vikas Bachhal 
Designation  Additional Professor 
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Orthopaedics, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Chandigarh, Sector 12, India.

Chandigarh
CHANDIGARH
160012
India 
Phone  7087928664  
Fax    
Email  vikasbachhal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shanborlang Siangshai 
Designation  Junior Resident Doctor 
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Orthopaedics, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Chandigarh, Sector 12, India.

Chandigarh
CHANDIGARH
160012
India 
Phone  7760581037  
Fax    
Email  shanbor329@gmail.com  
 
Source of Monetary or Material Support  
Department of Orthopaedics, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, India 
 
Primary Sponsor  
Name  Postgraduate Institute of Medical Education and Research  
Address  Department of Orthopaedics, Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh, 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 Shanborlang Siangshai  Postgradute Institute of Medical Education and Research  Department of Orthopaedics, Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh - 160012
Chandigarh
CHANDIGARH 		 7760581037

shanbor329@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C402||Malignant neoplasm of long bones of lower limb,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Negative pressure wound therapy  Negative pressure wound therapy is a medical device which uses negative pressure to provide suction over wounds, closed or open, aiding in reducing wound complications by reducing edema, secretions and increasing local blood flow. NPWT will be applied for a duration of 4 post-operative days for every case randomized into this arm. 
Comparator Agent  Standard of care  The standard of care dressing followed by the Institute will be used as a comparator. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Bone tumours around the knee.
2. Should be willing to participate in the study. 
 
ExclusionCriteria 
Details  1. Any contraindications to negative pressure wound therapy.
2. Bone tumours with active infection over surgical site.
3. Bone tumours requiring revision surgery.
4. Allergy to adhesive dressing.
5. Bone tumours requiring amputation as primary.
6. Any on-going bleeding disorder or coagulopathy.
7. Co-morbidities: Diabetes mellitus, peripheral vascular disease.
8. Patient receiving local radiation.
9. Patient with deranged albumin levels.
10. Refuses participation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Wound healing by measuring the time taken by the wound to dry as per Southampton Wound Grading of Grade 2 or less  30 days post-operative 
 
Secondary Outcome  
Outcome  TimePoints 
Wound complications like:
1. Wound dehiscence
2. Surgery to operative site within 30 dats post-operatively .
3. Increased surgical drain volume.
4. Surgical site infections 		 30 days post-operative 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   Phase 4 
Date of First Enrollment (India)   14/04/2025 
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="5"
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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Through email at shanbor329@gmail.com

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

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

This will be a prospective randomized control study conducted at PGIMER. All the patients with bone tumours fulfilling the inclusion criteria will be included in the study. The patients will be prospectively randomized by a computer generated block randomization into one of the two treatment groups: one group receiving negative pressure wound therapy and the other receiving standard of care. The patient will be followed up for 1 month post-operatively to monitor for wound healing and wound complications.

 
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