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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 7
- 主要终点
- Reduction in scarring as assessed using the Vancouver Scar Scoring Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female aged 18 years and older.
- •Female subjects must be post-menopausal or surgically sterilized.
- •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.
- •Subjects undergoing Laparoscopic procedures with at least two 10 mm long full-thickness surgical incisions.
- •Signed informed consent form.
排除标准
- •Subjects with a history of skin irritation or infection in the past 6 months in the intended area of incision.
- •Subjects with a history of keloids.
- •Known conditions of collagen vascular diseases.
- •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/1.7m
- •Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range.
- •Hepatic insufficiency defined as total bilirubin 2 mg/dL or serum albumin 25 g/L.
- •Hemoglobin 10 g/dL in males and 9 g/dL in females.
- •Hematocrit 0.
- •Platelet count 100,
- •Presence of an active systemic or local cancer or tumor of any kind (with the exception of nonmelanoma skin cancer).
- •Current treatment with systemic corticosteroids (15 mg/day), or immunosuppressive agents.
- •Previous or current radiation therapy or likelihood to receive this therapy during study participation.
- •Pregnant or nursing subjects.
- •Known prior inability or unavailability to complete required study visits during study participation.
- •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.
- •Use of any investigational drug or therapy within the 28 days prior to screening.
- •Any other factor, which may, in the opinion of the Investigator, compromise participation and follow-up in this study.
结局指标
主要结局
Reduction in scarring as assessed using the Vancouver Scar Scoring Scale
时间窗: from week 2 to end of study at month 9
次要结局
- Reduction in scarring as assessed using the Vancouver Scar Scoring Scale.(from week 2 to month 1, 3 and 6)
- Reduction in scarring using the Patient and Observer Scar Assessment Scale.(from week 2 to month 1, 3, 6 and 9)
- 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.)