CTRI/2021/07/034509
Completed
未知
Prospective, international, multicenter, observational study to evaluate theclinical performance and safety of a DACC-impregnatedtransparent postoperative dressing
Essity India Private Limited0 sites112 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: O- Medical and Surgical
- Sponsor
- Essity India Private Limited
- Enrollment
- 112
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Signed informed consent to participate in this study
- •2\.Men, women or diverse
- •3\.ââ?°Â¥ 18 years of age
- •4\.Patient is mentally and physically able to participate in this study
- •5\.Wound from gastrointestinal or orthopaedical surgeries indicated for treatment with the investigational products for a time period of 14 days
Exclusion Criteria
- •1\.Infection of the target wound
- •2\.Patients actively taking antibiotics for other conditions up to the day of surgery (not including surgical prophylaxis or antibiotic use related to the index procedure)
- •3\.Subjects require placement of external fixators
- •4\.Any drug addiction including alcohol
- •5\.Known sensitivity or allergy to any component of the study product
- •6\.Patients who participate in any other clinical study investigating drugs or medical devices
- •7\.Patients not willing to attend at follow\-up visits
- •8\.Patients not able to give consent
- •9\.Pregnant or breastfeeding patients
Outcomes
Primary Outcomes
Not specified
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