Health Condition 1: K929- Disease of digestive system, unspecified Health Condition 2: O- Medical and Surgical
Conditions
Interventions
Intervention1: Surgipler 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: T
Sponsors
IPGMER and SSKM Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients of 18-70 years (both age included) 2. Patients undergoing open abdominal surgeries 3. Ready to give consent
Exclusion criteria
Exclusion criteria: 1. Patients with uncontrolled diabetes i.e., HbA1c >10% on day of screening 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. Investigator’s discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rate of surgical site infection between skin stapler and polyamide sutureTimepoint: 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 Seraj Ahmed
IPGMER SSKM HOSPITAL
Outcome results
None listed