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CTRI Number  CTRI/2024/05/067053 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 07/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) [Negative pressure wound therapy ]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   A a randomized controlled study. to study the clinical outcome of vacuum assisted dressing and conventional saline dressings in management of chronic non healing ulcers  
Scientific Title of Study   A clinical outcome of using vacuum assisted dressing and conventional saline dressings in management of chronic non healing ulcer - A 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  Dr PriyaDharshini  
Designation  post graduate in general surgery 
Affiliation  Aarupadai veedu medical college and hospital 
Address  C block department of general surgery Aarupadai Veedu Medical College- kirumampakkam, pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  09629981779  
Fax    
Email  drpriyaa99@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Ramachandradu 
Designation  Professor  
Affiliation  Aarupadai veedu medical college 
Address  C block department of general surgery Aarupadai Veedu Medical College- Kirumampakkam pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  09629981779  
Fax    
Email  general.surgery@avmc.edu.in  
 
Details of Contact Person
Public Query  
Name  DR Ramachandradu 
Designation  Professor  
Affiliation  Aarupadai veedu medical college 
Address  C block department of general surgery Aarupadai Veedu Medical College- Kirumampakkam pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  09629981779  
Fax    
Email  general.surgery@avmc.edu.in  
 
Source of Monetary or Material Support  
Aarupadai veedu medical college and hospital , Kirumampakkam, Pondicherry 607402 
 
Primary Sponsor  
Name  Aarupadai veedu medical college and hospital 
Address  C block , department of general surgery aarupadai veedu medical college and hospital kirumampakkam pondicherry 607402 
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 
Dr Priyadharshini   Aarupadai veedu medical college and hospital  Room no 10 ; Department of general surgery; C block Aarupadai Veedu Medical College and hospital Kirumapakkam Pondicherry
Pondicherry
PONDICHERRY 		 9629981779

drpriyaa99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AVMC INSTITUTIONAL HUMAN ETHICAL COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L984||Non-pressure chronic ulcer of skin, not elsewhere classified, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Negative pressure wound therapy   application of a vacuum assisted across the surface of a non healing ulcer embedded through a foam dressing which is cut to fit the ulcer Period of observation till 8 weeks  
Comparator Agent  Saline dressing   Saline dressing over chronic non healing ulcer Period of observation 4 to 8 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with non healing ulcer attending opd of AVMC above 18 years
Patients with non healing ulcer who volunteer for trial
Neuropathic ulcer patients
Dehisced wound ulcers with exposed tendons or bone  
 
ExclusionCriteria 
Details  Wounds with complete necrosis of tissue requiring amputation at time of admission to hospital

Patients with bleeding disorders

Patients with malignant ulcer

Patients with untreated osteomyelitis/ unstable fracture within vicinity of the wound

Abdominal wounds 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to study the outcome of healing in vacuum assisted dressing over saline dressing in non healing ulcer
 		 Base day of debridement ,weekly (saline), day 5 of npwt ; post ssg / amputation weekly , monthly
 
 
Secondary Outcome  
Outcome  TimePoints 
to find out the difference in duration of hospital stay
to find out the rate of non healing ulcers going into amputation.  		 Base day of debridement ,weekly (saline), day 5 of npwt ; post ssg / amputation weekly , monthly
 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   20/05/2024 
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="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

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drpriyaa99@gmail.com].

  6. For how long will this data be available start date provided 01-06-2024 and end date provided 31-12-2028?
    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  

After correction from the IRC&IEC, convenient sampling of patients attending op and ipd services during the study period mentioned, fulfilling the inclusion and exclusion criteria as listed will be recruited for the study, after obtaining informed written consent under the guidance of the guide and co-guide.
The nature, purpose and their roles in the study will be explained in detail, including the information that their non-participation in the study would not affect the quality of their treatment that they are to receive and that they are free to exit the study at any time. After assuring that their responses would remain confidential, an informed written consent for the same shall be obtained from all participants
Data will be collected using a pre-tested semi-structured proforma to collect sociodemographic details about the patients participating in the study.
Patients based on convenience sampling will be divided into group A& group B
Pre operatively in both the groups detailed history will be taken and routine investigations like HB, TC, DC, ESR, RBS, SEROLOGY, ECG, LFT, RFT, PUS C/S will be done.
Wound preparation will be done by removing the dressing from the wound and discarded. Aculture swab for microbiology culture will be taken before the wound irrigation with normal saline.
Surgical debridement will be done and adequate haemostas is will be achieved.
Sterile, open-cell foam dressing will be gently placed into the wound cavity. the site will be then sealed with an adhesive drape ensuring that the drapes covered the foam and the fenestrated tube inside. Drapes should be placed till three to five centimeters of surrounding healthy tissue.
Controlled pressure will be uniformly applied to all tissues on the inner surface of the wound using centralized vacuum pump. The pressure could be delivered either continuous or intermittent type, ranging from 50 to 125 mm hg. The foam dressing will get compressed in response to the negative pressure. The pressure will be applied continuously for the first 48 hours and then changed to continuos or intermittent therapy
Saline dressing daily will be done in control group
After 5 days the vac will be removed and the wound healing rate will be assesed; culture swab for microbiology will be taken
Data will be tabulated, analyased based on statistical tests
Results obtained and conclusions will be drawn
 
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