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A clinical trial to assess the comparative efficacy and safety of a silver dressing against standard cotton dressing in the rate of Wound Healing after and operative procesure

A prospective assessor-blind, randomized controlled clinical trial to assess the efficacy and safety of Sterizone (an antimicrobial silver dressing) v/s standard cotton dressing in Post- Operative Wound Healing

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/03/008090
Enrollment
100
Registered
2017-03-14
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- The subject is having surgery (Cesarean pfannenstiel or Open Laparotomy incision) within 1 week

Interventions

Intervention1: Sterizone Silver Dressing: Sterizone is an Anti-microbial Silver wound dressing. Control Intervention1: Standard Cotton Dressing: This will be the standard care cotton dressing currentl

Sponsors

Clinfound Clinical Research Services PvtLtd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.The subject is willing and able to understand, sign and date the study Informed Consent, and be able to adhere to the scheduled visits regimen. 2.The subject is having surgery (Cesarean pfannenstiel or Open Laparotomy incision) within 1 week

Exclusion criteria

Exclusion criteria: 1.Patients with known allergy or topical hypersensitivity to ionic silver or alginate 2. Any systemic or local active dermatological disease that might interfere with the evaluation of the surgical site such as eczema, psoriasis, skin cancer, scleroderma, chronic urticarial 3.Patients undergoing MRI (Magnetic Resonance Imaging) examination. 4.Subject residence is outside the study center city 5.Patients was participating in another clinical trial less than 30 days before participation in this trial

Design outcomes

Primary

MeasureTime frame
Wound infection rate within 5 days after operationTimepoint: Day 1,Day 3,Day 5 ,Day 30

Secondary

MeasureTime frame
Adverse eventsTimepoint: Day 1,Day 3,Day 5,Day 15 ,Day 30;Exudates absorption capacityTimepoint: Day 1,Day 3,Day 5,Day 30;Patient and observer scar assessment scaleTimepoint: Day 5,Day 15,Day 30;Photograph of the woundTimepoint: Day 1,Day 5,Day 15,Day 30;Stony Brooks scar evaluation scaleTimepoint: Day 1,Day 3,Day 5 ,Day 30;Wound keloid formation rateTimepoint: Day 5 ,Day 30

Countries

India

Contacts

Public ContactDr Sreejith Sreekumar

Krishna Institute of Medical Sciences

drsundari@gmail.com

Outcome results

None listed

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