A Prospective Phase IV, cross over, single centre, investigator blinded study to evaluate the efficacy of Contractubex® Gel in the reduction and prevention of post surgery hypertrophic scar and keloid in subjects having undergone surgery by Sternotomy
- Conditions
- Health Condition 1: null- Males and females with recent (within 20 days) cardiac surgery.
- Registration Number
- CTRI/2012/12/003170
- Lead Sponsor
- MS Clinical Research Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 80
Males and females with recent (within 20 days) cardiac surgery.
Age: 18 years or older
The subject willing and able to complete the entire course of the trial and comply with the trial instructions
Written informed consent
Any other planned topical treatment in the scar area
Any surgical wound discharge like purulent and serous at the time of initiation of therapy.
Tumorigenic changes in the area to treat, independent of tumor dignity
Any severe or uncontrolled systemic disease (e.g. pulmonary, hepatic, or gastrointestinal), malignant tumor, or medical history of HIV infection
Known allergy or sensitivity to the trial medication or its components.
Non compliant subjects
Psychiatric problems which, in the investigatorâ??s opinion, are severe enough to interfere with the trial results
Participation in another clinical trial within 30 days prior to screening
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of Contractubex® Gel in reducing and preventing post surgery hypertrophic scar in immediate treatment (within 20 days post surgery) Vs no treatment for a period of six months.Timepoint: V1-Baseline (within 20days after surgery), V2-week 12, V3-week 24, V4 - week 36, V5-week 48
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy of Contractubex® Gel in reducing post surgery scar in delayed treatment (starting of treatment six months post surgery) Vs no treatment (where subjects had prior treatment with Contractubex® gel for a period of six months).Timepoint: V1-Baseline (within 20days after surgery), V2-week 12, V3-week 24, V4 - week 36, V5-week 48