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PILOT STUDY TO CHECK THE WOUND HEALING PROPERTY OF THE 4 DRESSING APPLICATIONS IN PATIENTS WITH OPEN WOUND

AN OPEN LABEL, NON RANDOMIZED, PARALLEL PILOT STUDY TO CHECK THE WOUND HEALING PROPERTY OF THE 4 DRESSING APPLICATIONS DEVELOPED BY SITRA (SOUTH INDIA TEXTILE RESEARCH ASSOCIATION) IN INDIAN ADULT PATIENTS WITH OPEN WOUND - -

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/04/003571
Enrollment
60
Registered
2013-04-22
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- Patient with open wound

Interventions

Intervention1: Chitosan Treated Cotton Gauze (CTC): Chitosan Treated Cotton Gauze (CTC) - The drug would be applied for three days and OD dosage. Intervention2: Tetracycline drug applied on Chitosan T

Sponsors

Mr Sakthivel Perumalsamy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Age >18 years of both sex •Subjects with any general wound which is open •Wound should be partial thickness in classification and should be less than or equal to 2 inches (5 cm) in diameter •Subjects currently does not need the administration of any other antibiotic course or any other intensive treatment methods, as per the investigatorâ??s discretion •Subjects without any major health problem which may have an effect on the study results as per the investigatorâ??s discretion •Subjects should be able to comply with the study procedures and schedules •Subjects should be able to understand study information provided and give written informed consent after being explained to by the physician. She/he must be aware of the experimental nature of the therapy, its potential benefits, side effects, risks and discomforts

Exclusion criteria

Exclusion criteria: •Immunocompromised subjects •Subjects with the addiction to cigarettes, alcohol and narcotics, including opium •Subjects with the known history of major illness /disorders as per the Investigatorâ??s discretion •Subjects with documented hypersensitivity reaction to Chloramphenicol •Subjects with documented hypersensitivity reaction to Chitosan •Subjects with documented hypersensitivity reaction to Tetracycline •Subjects with documented hypersensitivity reaction to Oxytetracycline •Pregnant Women •Breast feeding Women •Patient/Legally acceptable representative; who is unable to give consent •Patient who is currently enrolled in any other investigational drug study

Design outcomes

Primary

MeasureTime frame
1.To assess the efficacy of wound dressing applications (wound healing rate) in wound patients a)% of reduction in the wound size from the baseline till the end of Day 5 Timepoint: From Screening till the end of every visit From Screening till the end of study

Secondary

MeasureTime frame
1. To assess the safety of wound dressing applications 2. To assess the reduction in the wound pain (Pain Management)Timepoint: From the Screening till the end of every visit From the Screening till the end of the study

Countries

India

Contacts

Public ContactMrs Nagalakshmi AnandaPadmanabhan

Srinivasam Cancer Care Hospital India

kcluck@gmail.com09448055949

Outcome results

None listed

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