A clinical trial to assess the comparative efficacy andsafety of a silver dressing against standard cotton dressing in the rate of Wound Healing after and operative procesure
- Conditions
- Health Condition 1: null- The subject is having surgery (Cesarean pfannenstiel orOpen Laparotomy incision) within 1 week
- Registration Number
- CTRI/2017/03/008090
- Lead Sponsor
- Clinfound Clinical Research Services PvtLtd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wound infection rate within 5 days after operationTimepoint: Day 1,Day 3,Day 5 ,Day 30
- Secondary Outcome Measures
Name Time Method 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 <br/ ><br>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