A Prospective Phase IV, cross over, single centre, investigator blinded study to evaluate the efficacy of ContractubexÂ® Gel in the reduction and prevention of post surgery hypertrophic scar and keloid in subjects having undergone surgery by Sternotomy

A Prospective Phase IV, cross over, single centre, investigator blinded study to evaluate the efficacy of ContractubexÂ® Gel in the reduction and prevention of post surgery hypertrophic scar and keloid in subjects having undergone surgery by Sternotomy - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2012/12/003170

Enrollment

Registered

2012-12-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Males and females with recent (within 20 days) cardiac surgery.

Interventions

Intervention1: ContractubexÂ® Gel: In Immediate treatment group- Approximately 1.5 FTU of the gel is applied onto the scars. Frequency of application-thrice daily Total duration of therpy in immediate

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of ContractubexÂ® 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

Measure	Time frame
To evaluate the efficacy of ContractubexÂ® 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 ContractubexÂ® 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	—

Countries

India

Contacts

Public ContactDr Mukta Sachdev

MS Clinical Research Pvt Ltd

mukta.sachdev@mscr.in91-80-40917253

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026