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

Not Applicable

Recruiting

• Conditions: 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

This study is a 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-Op Wound Healing.100 patients who will undergo surgery (Cesarean pfannenstiel or Open Laparotomy incision) within 1 week will be recruited from KIMS Hospital,Hyederabad, OBG and Gynec Department.Patients with confirmed eligibility will be randomized into two groups. One group will receive Sterizone Silver Dressing and the other group standard cotton dressing for wound healing. Both groups will be followed up for 30 days over 4 visits.The primary objective of this study is to evaluate through clinical criteria the clinical efficacy and safety of Sterizone

(an antimicrobial silver dressing) role in obstetrical and gynecological wound healing is as effective and safe as Standard cotton dressing. The secondary objective is to assess the safety parameters

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-20
• Last Update Posted: 2017-05-25

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 100

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

• 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 operation	Day 1,Day 3,Day 5 ,Day 30

Secondary Outcome Measures

Name	Time	Method
Exudates absorption capacity	Day 1,Day 3,Day 5,Day 30
Stony Brooks scar evaluation scale	Day 1,Day 3,Day 5 ,Day 30
Wound keloid formation rate	Day 5 ,Day 30
Patient and observer scar	assessment scale
Photograph of the wound	Day 1,Day 5,Day 15,Day 30
Adverse events	Day 1,Day 3,Day 5,Day 15 ,Day 30

Trial Locations

Locations (1)

Krishna Institute of Medical Sciences; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Krishna Institute of Medical Sciences

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr Tripura Sundari M

Principal investigator

09885611977

drsundari@gmail.com