Surgical Site Infection
Conditions
Keywords
Infection, SSI, SSIs, Laparatomy, Prolene suture, Staples, Wound Dehiscence, General surgery
Brief summary
Surgical site infection (SSI) is one of the most common postoperative complications following elective laparotomy and contributes significantly to patient morbidity, prolonged hospital stay, and increased healthcare costs. Various techniques are available for skin closure, including skin staples and polypropylene sutures; however, evidence regarding their comparative effectiveness remains inconsistent, particularly in low- and middle-income countries. This randomized controlled trial aims to compare skin staples with polypropylene sutures for skin closure following elective laparotomy. Eligible adult patients undergoing elective laparotomy at the Department of General Surgery, Pakistan Institute of Medical Sciences (PIMS), Islamabad, will be randomly allocated in a 1:1 ratio to receive either skin staples or polypropylene sutures. The primary outcomes are skin closure time and incidence of surgical site infection within 30 days of surgery. Secondary outcomes include wound dehiscence, postoperative pain, cosmetic scar appearance, patient satisfaction, and duration of hospital stay. The findings will provide evidence regarding the optimal skin closure technique for elective laparotomy in the Pakistani population.
Interventions
DEVICESkin staples
Disposable stainless steel skin staples will be used for skin closure following elective laparotomy. Skin closure will be performed according to the standard surgical technique of the Department of General Surgery, Pakistan Institute of Medical Sciences (PIMS), immediately after completion of fascial closure.
DEVICEPolypropylene skin suture
Skin closure will be performed using interrupted polypropylene (Prolene) sutures following elective laparotomy according to the standard surgical technique of the Department of General Surgery, Pakistan Institute of Medical Sciences (PIMS).
Sponsors
Pakistan Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Age 15-50 years Elective laparotomy ASA I-III Written informed consent Male or female
Exclusion criteria
Emergency surgery Previous SSI Recurrent surgery BMI \<18 or \>30 kg/m² Haemoglobin \<10 g/dL COPD Stroke Renal failure Liver disease Haematological disorders Malignancy Immunocompromised state Active infection Previous chemotherapy Previous radiotherapy Malnutrition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infection | 30 days | SSI occurring within 30 postoperative days based on CDC clinical criteria with wound culture where indicated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin closure time | During the surgery | Measured in seconds from the first skin puncture until completion of skin closure. |
| Wound Dehiscence | 30 days | Giving way of the skin closure leading to exposure of subcutaneous tissues. |
| Post-operative pain | 7 days | Pain scored on verbal descriptor scale from 1 to 10 |
| Scar appearance | 6 weeks | Visual description of scar on analogue scsle by subjective assessment(1-10) |
Countries
Pakistan
Outcome results
None listed