Health Condition 1: Z481- Encounter for planned postprocedural wound closure
Conditions
Interventions
Intervention1: Skin stapler: Skin closure using disposable sterile stainless steel skin stapler (Surgipler Neo) applied as per manufacturers instructions.
Control Intervention1: Poliglecaprone-25 sutu
no external sutures.
Sponsors
Adichunchanagiri Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Pregnant women aged 18–45 years undergoing LSCS (elective or emergency) Skin closure planned with single layer subcuticular technique Able and willing to provide written informed consent and attend follow-up visits
Exclusion criteria
Exclusion criteria: Known allergy to suture or staple material Current systemic infection or immunosuppression (e.g., long-term steroids, chemotherapy) Known bleeding disorder Significant obesity where fascial closure or wound management is expected to differ (BMI greater than 40 kg/m²) Multi-layer disrupted closure or major intraoperative complication requiring re-exploration Previous lower abdominal surgery with distorted anatomy at incision site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of surgical site infection (SSI), defined according to standard criteria (purulent drainage from incision, culture positive wound drainage, or physician diagnosis of superficial/deep incisional SSI requiring antibiotics or wound opening)Timepoint: Incidence of SSI within 30 days post operation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cosmetic outcome of the scar measured by a validated scale — e.g., Patient and Observer Scar Assessment Scale (POSAS)Timepoint: Day of discharge, 30 days post operation and 3 months post operation;Wound-related complications: seroma, hematoma, wound dehiscence/separation (partial/full), suture extrusion, hypertrophic scar/keloid formationTimepoint: Within 3 months of post operation;Postoperative pain at incision site (measured by Visual Analogue Scale)Timepoint: 24 hours post operation, 7 days post operation and 30 days post operation;Time taken for skin closure during Cesarean sectionTimepoint: Day of surgery;Re-admission related to wound complicationsTimepoint: within 30 days post operation;Patient satisfaction with wound healing (Likert scale)Timepoint: 3 months post operatively | — |
Countries
India
Contacts
Public ContactMahendra G
Adichunchanagiri Institute of Medical Sciences
Outcome results
None listed