| CTRI Number |
CTRI/2011/09/002004 [Registered on: 14/09/2011] Trial Registered Prospectively |
| Last Modified On: |
27/08/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
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To Study Safety and Efficacy of GRANEXIN GEL plus Standard of Care as compared to standard of Care alone in reducing scar formation in wounds following laparoscopic surgery |
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Scientific Title of Study
|
A Phase II, Prospective, Randomized, Double blind, Within-Subject Control, Multi-Center Study to Determine the Safety and Efficacy of GRANEXIN GEL in Reducing Scar Formation in Surgical Incisional Wounds following Laparoscopic Surgery |
| Trial Acronym |
Nil |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2011-LSS-001 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
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| Name |
Dr Atul Gupta |
| Designation |
Medical Monitor |
| Affiliation |
Max Neeman International |
| Address |
Max Neeman International Ltd.
MaX House, 1st Floor
1, Dr Jha Marg, Okhla - III
New Delhi - 110 020
South
DELHI
110 020
India |
| Phone |
91-9717287654 |
| Fax |
91-11-41001945 |
| Email |
Atul.Gupta@neemanasia.com |
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Details of Contact Person
Public Query
Modification(s)
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| Name |
Dr Jayashri Krishnan |
| Designation |
Associate Director-Monitoring |
| Affiliation |
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| Address |
Max Neeman Medical International,No. 11 A,TNGO Colony, I Street, Nanganallur
Chennai
TAMIL NADU
600061
India |
| Phone |
91-9952910703 |
| Fax |
|
| Email |
Jayashri.Krishnan@neemanasia.com |
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Source of Monetary or Material Support
|
| FirstString Research, Inc.
475-A East Bay Steet
Charleston, SC 29403
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Primary Sponsor
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| Name |
FirstString Research Inc |
| Address |
475-A East Bay Steet
Charleston, SC 29403
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| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
Sites of Study
Modification(s)
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| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Meenakshi Sharma |
Paras Hospitals |
Paras Hospitals, Department of General and Laproscopic surgery, Room No.37, Ground Floor
C-1 Block,Sushant Lok, Phase-I,Sec-43, Gurgaon,
Haryana-122002
Gurgaon
HARYANA |
91-9810794347
91-124-4585572
doctor_sharma@hotmail.com |
| Dr G Venkat Rao |
Asian Institute of Gastroenterology |
Asian Institute of Gastroenterology , Department of Gastroenterlogy and Minimal Invasive surgery
6-3-661,Somajiguda,
Hyderabad.
Hyderabad
ANDHRA PRADESH |
91-40-23378888
91-40-23324255
drraogv@sify.com |
| DrNirmal Chopra |
Dr.Chopra Super Specality Hospital |
Surgeon Gynecologist
Dr.Chopra Super Specality Hospital,Gurdhuwar Road,Sadar Bazar,Agra-UP
Agra
UTTAR PRADESH |
91-9359488842
drgmprasad@gmail.com |
| Dr J S Rajkumar |
Life Line Mutispeciality Hospital |
Life Line Mutispeciality Hospital, Department of Surgical Gastro Enterelogy, Ground Floor,
No 5/639, Rajiv Gandhi Salai (OMR)
Perungudi, Chennai 600 096. Chennai 600 096
Chennai
TAMIL NADU |
91-9840599666
91-44-42803004
rjkmr_js@yahoo.co.in |
| Dr Jayashree Shankarrao Todkar |
Poona Hospital & Research Centre |
Poona Hospital & Research Centre, Deaprtment of Laproscopic Surgery and Bariatric Surgery
27 Sadshiv Peth,Pune 411030
Pune
MAHARASHTRA |
91-9823090505
91-20-24338477
jayatodkar@hotmail.com |
| Dr Prashant Vithalrao Rahate |
Rahte Surgical Hospital & ICU |
Rahte Surgical Hospital & ICU, Department of General Laproscopic Surgery
517,Kolba swami square
Old mangalwari, central avenue
Nagpur – 440008,
Maharastra, India
Nagpur
MAHARASHTRA |
91-9822464068
91-712-6536080
prashantrahate84@yahoo.com |
| Dr A Ravi |
Sri RamaChandra Medical Center |
Sri RamaChandra Medical Center, D2 Secod Floor, Department of Gastro Enterology, Chennai-600116,Tamil Nadu
Chennai
TAMIL NADU |
91-44-24768637
91-44-45928678
draravi2k@yahoo.com |
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Details of Ethics Committee
Modification(s)
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| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Asian Institute of Gastroenterology 6-3-661,Somajiguda, Hyderabad |
Approved |
| Institutional Ethics Committee Dr.Chopra Super Specality Hospital,Gurdhuwar Road,Sadar Bazar,Agra-UP |
Approved |
| Institutional Ethics Committee Life Line Mutispeciality Hospital No 5/639, Rajiv Gandhi Salai (OMR) Perungudi, Chennai 600 096 |
Approved |
| Institutional Ethics Committee Paras Hospitals C-1 Block, Sushant Lok, Phase-I, Sec-43, Gurgaon, Haryana-122002 India |
Approved |
| Institutional Ethics Committee Poona Hospital & Research Centre 27 Sadshiv Peth, Pune 411030 |
Approved |
| Institutional Ethics Committee Rahte Surgical Hospital & ICU 517, Kolba Swami square, Central Avenue, Nagpur -08 |
Approved |
| Institutional Ethics Committee Sri RamaChandra Medical Cente Chennai-600116,Tamil Nadu, India |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Scar Formation in Surgical Incisional Wounds following Laparoscopic Surgery, |
|
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Control Incisional site: Standard of Care would be occlusive dressing achieved with Tegaderm |
Control Incisional site: Standard of Care would be occlusive dressing achieved with Tegaderm |
| Intervention |
GRANEXIN GEL |
Study treatment incisional site: GRANEXIN GEL is a low molecular weight gap junction (ACT-1) peptide formulated in 1.25% Hydroxyethylcellulose gel for topical applications for the management of wounds . 100 μM concentration of GRANEXIN GEL will be applied at Day 1 and Day 2 along with standard of care achieved with Tegaderm. GRANEXIN GEL will be applied over the muscle before suturing and over the incision site after suturing. Incision will be covered completely with occlusive dressing after suturing. |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female aged 18 years and older.
2a. Female subjects must be post-menopausal or surgically sterilized.
or
2b. Female subjects of childbearing potential must have negative pregnancy test at screening, and agrees to use hormonal contraceptive or intra-uterine device or diaphragm with spermicide or condom with spermicide or abstinence throughout the study.
3. Subjects undergoing Laparoscopic procedures with at least two 10 mm long full-thickness surgical incisions.
4. Signed informed consent form.
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| ExclusionCriteria |
| Details |
1. Subjects with a history of skin irritation or infection in the past 6 months in the intended area of incision.2. Subjects with a history of keloids.3. Known conditions of collagen vascular diseases.4. Subjects with clinically significant medical conditions as determined by the Investigator, which would impair wound healing including renal, hepatic, hematologic, neurologic or immune disease.
Examples include but are not limited to:
a. Renal insufficiency as an estimated GFR, which is 30 mL/min/1.7m2.
b. Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range.
c. Hepatic insufficiency defined as total bilirubin 2 mg/dL or serum albumin 25 g/L.
d. HbA1c 9.0%.
e. Hemoglobin 10 g/dL in males and 9 g/dL in females.
f. Hematocrit 0.30.
g. Platelet count 100,000.
5. Presence of an active systemic or local cancer or tumor of any kind (with the exception of nonmelanoma skin cancer).6. Current treatment with systemic corticosteroids (15 mg/day), or immunosuppressive agents.7. Previous or current radiation therapy or likelihood to receive this therapy during study participation.8. Pregnant or nursing subjects.9. Known prior inability or unavailability to complete required study visits during study participation.10. A psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem, determined from the subjects medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance.11. Use of any investigational drug or therapy within the 28 days prior to screening.12. Any other factor, which may, in the opinion of the Investigator, compromise participation and follow-up in this study.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Participant and Investigator Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Reduction in scarring as assessed using the Vancouver Scar Scoring Scale |
from week 2 to end of study at month 9 |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| Reduction in scarring using the Patient and Observer Scar Assessment Scale. |
from week 2 to month 1, 3, 6 and 9 |
| Reduction in scarring as assessed using the Vancouver Scar Scoring Scale. |
from week 2 to month 1, 3 and 6 |
| Investigators wound assessment using the Global Assessment scale |
from baseline to week 2, month 1, month 3, month 6 and month 9 |
| Investigators assessment of healing rate and incidence of infections. |
from day 3 till study exit |
| Incidence of treatment related adverse events. |
through out the study. |
|
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Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
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Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
08/10/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
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none as yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
This Phase II, prospective study is designed as a multicenter, double blind, within-subject control study in which subjects undergoing laparoscopic surgery will be randomly allocated to receive concentration GRANEXIN GEL plus Standard of Care (SoC) as compared to Standard of Care alone following the surgery. 100 μM concentration of GRANEXIN GEL will be applied at Day 1 and Day 2 along with standard of care. The outcome of this study would be Reduction in scarring from week 2 to end of study at month 9 as assessed using the Vancouver Scar Scoring Scale, Patient and Observer Scar Assessment Scale, Investigator’s wound assessment using the Global Assessment scale from baseline to week 2, month 1, month 3, month 6 and month 9 and Investigator’s wound assessment using the Global Assessment scale from baseline to week 2, month 1, month 3, month 6 and month 9. |