Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Trupler Skin Stapler: Skin staples made up of stainless steel which will be applied for skin closure and which will be removed 7 to 14 days after application.
Control Intervention1: Tru
Sponsors
Burdwan Medical College
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients of 18-70 years (both age included) 2. Patients undergoing open abdominal surgeries or elective orthopedic surgery 3. Ready to give consent
Exclusion criteria
Exclusion criteria: 1. Patients with uncontrolled diabetes i.e., HbA1c >10% 2. Patients with Hemoglobin 3. Patients with BMI > 35kg/m2 4. Patients having history of surgical incision in the same site as current planned surgery 5. Patients with systemic infection not controlled by antibiotic treatment 6. Patients with topical infection at the planned incision site 7. Patient’s undergoing surgery for accidental trauma 8. Investigator’s discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the incidence of surgical site infection between skin stapler and polyamide suture using CDC criteriaTimepoint: Enrolment/Surgery (Day 0, Visit 1) Post-Surgery: Day 3±1 (Visit 2), Day 7 to 14±2 (Visit 3), Week 6 ± 7 days (Visit 4), Week 12 ± 7 days (Visit 5) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate wound complications such as skin disruption, wound dehiscence, sinus formation, seroma and hematoma 2. To assess post-operative pain including pain during staple/suture removal, and subject satisfaction 3. To assess the time taken for skin closure 4. To assess the cosmetic appearance of the wound 5. To assess the ease of use of two interventions 6. To evaluate adverse eventsTimepoint: Enrolment/Surgery (Day 0, Visit 1) Post-Surgery: Day 3±1 (Visit 2), Day 7 to 14±2 (Visit 3), Week 6 ± 7 days (Visit 4), Week 12 ± 7 days (Visit 5) | — |
Countries
India
Contacts
Public ContactDr Debdatta Chatterjee
Burdwan Medical College
Outcome results
None listed