Health Condition 1: null- Scar Formation in Surgical Incisional Wounds following Laparoscopic Surgery
Conditions
Interventions
Intervention1: 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
M 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 incisio
Sponsors
FirstString Research Inc
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in scarring as assessed using the Vancouver Scar Scoring ScaleTimepoint: from week 2 to end of study at month 9 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of treatment related adverse events.Timepoint: through out the study.;Investigators assessment of healing rate and incidence of infections.Timepoint: from day 3 till study exit;Investigators wound assessment using the Global Assessment scaleTimepoint: from baseline to week 2, month 1, month 3, month 6 and month 9;Reduction in scarring as assessed using the Vancouver Scar Scoring Scale.Timepoint: from week 2 to month 1, 3 and 6;Reduction in scarring using the Patient and Observer Scar Assessment Scale.Timepoint: from week 2 to month 1, 3, 6 and 9 | — |
Countries
India
Contacts
Public ContactDr Jayashri Krishnan
Max Neeman International
Outcome results
None listed