| 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
|
|
|
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
|
|
|
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. |