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CTRI Number  CTRI/2024/03/063479 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 29/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing phenytoin vs saline instillation combined with vacuum therapy in wounds 
Scientific Title of Study   COMPARISON OF NEGATIVE PRESSURE WOUND THERAPY COMBINED WITH INSTILLATION OF TOPICAL PHENYTOIN VERSUS SALINE IN HEALING OF EXTREMITY ULCERS- A RANDOMIZED CONTROL 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  Yadunand Sriram 
Designation  Junior Resident 
Affiliation  JIPMER 
Address  DEPT OF GENERAL SURGERY JAWAHARLAL INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH, PONDICHERRY 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  9445216233  
Fax    
Email  yadunands@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Balamourougan K 
Designation  Additional Professor  
Affiliation  JIPMER 
Address  DEPT OF GENERAL SURGERY JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH, PONDICHERRY 605006


PONDICHERRY
605006
India 
Phone  9443617089  
Fax    
Email  drbalak@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Yadunand Sriram 
Designation  Junior Resident 
Affiliation  JIPMER 
Address  DEPT OF GENERAL SURGERY JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH, PONDICHERRY 605006


PONDICHERRY
605006
India 
Phone  9445216233  
Fax    
Email  yadunands@gmail.com  
 
Source of Monetary or Material Support  
JAWAHARLAL INSITITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH 
 
Primary Sponsor  
Name  JIPMER Intramural Research Fund 
Address  JIPMER PONDICHERRY 605006 
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 Yadunand Sriram  JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH  DEPT OF GENERAL SURGERY JIPMER PUDUCHERRY
Pondicherry
PONDICHERRY 
9445216233

yadunands@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Normal Saline instillation   All the patients with extremity wounds included in the study will undergo debridement either under local/regional block in minor procedure room or under general anesthesia in main operation theatre. Patients in group 2 will receive instillation with normal saline for 14 days 
Intervention  PHENYTOIN INSTILLATION  All the patients with extremity wounds included in the study will undergo debridement either under local/regional block in minor procedure room or under general anesthesia in main operation theatre. Patients in group 1 receiving NPWT with instillation topical phenytoin(2%). 2 vials of phenyotin (100 mg) will be diluted with saline and will be instilled once daily for a period of 14 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients with extremity ulcer between 18 and 75 yearS 
 
ExclusionCriteria 
Details  1.Patients diagnosed with peripheral vascular disease.
2.Acutely ischemic wounds.
3.Wounds with exposed blood vessels.
Wounds with undrained abscess.  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of negative pressure wound closure with topical phenytoin instillation on wound healing measured in terms of time to wound closure and percentage reduction in wound surface area  14 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the pathological strength of granulation
To assess the microbiological profile of the wound. 
14 DAYS 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   10/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/03/2024 
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 - NO
Brief Summary  

All the patients with extremity wounds included in the study will undergo debridement either under local/regional block in minor procedure room or under general anesthesia in main operation theatre.

A tissue bit sample from the edge of the wound will be sent for aerobic culture and sensitivity will be sent on admission. Wounds will be managed initially with surgical debridement and cleaning of the wound. Injection Ceftriaxone (one gram twice daily) and Metronidazole (500mg thrice daily) intravenous will be started empirically in all cases at admission and will be changed to appropriate antibiotic therapy based on the antimicrobial culture sensitivity pattern. A wedge of tissue of size approximately 2-3 mm will be taken from the edge of the wound for assessing histopathological parameters as well as for qualitative and quantitative bacterial cultures on day 1 of initiating NPWT.

A photograph of the wound will be taken. The surface area of the wound was measured using the smartphone based app(imito measure)6. The NPWT will be applied using sterile foam arranged in 2 layers over the wound with a drain tube placed in between the two layers of the foam. This system will be sealed using a sterile transparent plastic sheet with an adhesive surface on one side. Drain tube will be  connected to suction device and pressure set at - 125 mm Hg. Change of dressing will be done once every 48 hours. Patients in group 1 receiving NPWT with instillation topical phenytoin(2%) and group 2 received instillation with normal saline. 2 vials of phenyotin (100 mg) will be diluted with saline and will be instilled once daily for a period of 14 days. Instillation of the wound will be done four times a day at an interval of 4 hours with a dwell time of 10 minutes. Volume of saline for instillation was determined by the amount just enough to visibly saturate the foam as indicated by a darker color change in of the foam.

A repeat biopsy will be taken from the wound edge on 14th day of initiating NpWT  or earlier if the wound is ready for final closure, and sent for histopathology and bacteriology. A photograph of the wound will be taken again on day 14 following initiation of NPWT and wound surface area was measured using Imito measure smartphone based app to assess the percentage reduction in the size of the wound.

The primary outcome will be measured in terms of days from time of initiation of negative pressure wound therapy to the stage where the treating surgeon decides it is fit for wound closure. Secondary outcomes will be measured by assessing the bacterial burden of the wound, pathological strength of granulation tissue in terms of changes in surface epithelium, histological appearance of granulation tissue, changes in inflammatory cells, changes in proliferating blood vessels and fibroblastic reaction and changes in adnexal structures.

 
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