Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
Essity India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed informed consent to participate in this study 2. Men, women or diverse 3. = 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective: ? Incidence of superficial and deep surgical site infections after 5 to 7 days Secondary objectives: ? Incidence of superficial and deep surgical site infections after 14 and 30 daysTimepoint: baseline, 7 days post-surgery, 14 days post-surgery and 30 days postsurgery | — |
Secondary
| Measure | Time frame |
|---|---|
| ? Incidence of superficial and deep surgical site infections Type of surgical procedure ? Skin damage after dressing removal ? Pain at dressing removal ? Signs of infection ? Wound condition ? Condition of peri-wound skin ? Dressing adhesion ? Patient satisfaction ? Wound care giver satisfactionTimepoint: 7 days post-surgery, 14 days post-surgery and 30 days postsurgery | — |
Countries
India
Contacts
Public ContactHardy Schweigel
Global Clinical Affairs
Outcome results
None listed