This randomized controlled trial aims to compare the outcomes of Polyglactin (Vicryl) versus Polypropylene (Prolene) sutures for rectus sheath closure in patients undergoing midline laparotomy. The study will evaluate the rates of incisional hernia, surgical site infection (SSI), wound dehiscence, chronic pain, and suture sinus formation. Participants aged 18-70 years, undergoing either elective or emergency laparotomy, will be randomly assigned to receive either Polyglactin or Polypropylene sutures. The primary outcome measure is the incidence of incisional hernia at 6 months, with secondary outcomes including SSI, wound complications, and chronic pain. The study is particularly important in the context of Pakistan, where such comparative data is limited, and aims to provide evidence-based recommendations for optimal suture material selection in general surgery.

Study Design This randomized controlled trial is designed to compare the outcomes of two suture materials-Polyglactin 910 (Vicryl) and Polypropylene (Prolene)-for rectus sheath closure after midline laparotomy. The study will be conducted at the Department of General Surgery, Lady Reading Hospital, Peshawar, over 12 months. Participants will be randomly assigned to two groups: Group A (Polyglactin) and Group B (Polypropylene). The primary outcome is the rate of incisional hernia at 6 months postoperatively. Secondary outcomes include surgical site infection (SSI), wound dehiscence, chronic pain, and suture sinus formation.

■ Participants The study will include patients aged 18 to 70 years undergoing elective or emergency midline laparotomy with clean or clean-contaminated wounds (CDC Class I or II).

Inclusion Criteria:

Aged 18-70 years

Elective or emergency laparotomy

Clean or clean-contaminated wounds

Ability to provide informed consent

Availability for 6-month follow-up

Exclusion Criteria:

Contaminated or dirty wounds (CDC Class III or IV)

Immunocompromised patients (e.g., on steroids, chemotherapy, HIV)

Prior midline laparotomy with incisional hernia

Severe malnutrition (BMI <16 kg/m² or albumin <2.5 g/dL)

Pregnancy

Requirement for temporary abdominal closure or planned reoperation

■ Interventions

Polyglactin (Vicryl): A synthetic absorbable braided suture composed of glycolide and lactide copolymers. It is absorbed by hydrolysis over 56-70 days, providing temporary wound support during healing.

Polypropylene (Prolene): A synthetic non-absorbable monofilament suture known for its permanent tensile strength and excellent biocompatibility, offering long-term mechanical support and minimal tissue reaction.

Outcome Measures

Primary Outcome:

Incidence of incisional hernia at 6 months, confirmed by clinical examination and ultrasound if necessary.

Secondary Outcomes:

Surgical Site Infection (SSI): Defined as an infection occurring within 30 days post-surgery, classified as superficial, deep, or organ/space.

Wound Dehiscence: Partial or complete disruption of the abdominal wall closure within 30 days post-surgery.

Chronic Pain: Persistent pain at the surgical site lasting more than 3 months, assessed using the Visual Analog Scale (VAS).

Suture Sinus Formation: Chronic draining tract related to the suture material.

Statistical Analysis Data will be analyzed using SPSS version 26. Chi-square tests will compare proportions of complications between the two groups, and relative risk will be calculated with 95% confidence intervals. Stratified analysis will assess the impact of potential modifiers such as age, gender, and comorbidities (e.g., diabetes, hypertension).

Potential Impact The findings from this study aim to improve surgical outcomes in Pakistan and similar settings. By identifying the more effective suture material for rectus sheath closure, this research will help guide clinical practices, reducing common complications like incisional hernia and infection. It may also contribute to better surgical standards in regions lacking high-quality comparative data.

Inclusion Criteria:

1. Age: 18-70 years.
2. Type of Surgery: Patients undergoing elective or emergency midline laparotomy.
3. Wound Classification: Clean or clean-contaminated wounds (CDC Class I or II).
4. Ability to Provide Informed Consent: Participants must be able to understand and sign the informed consent form.
5. Availability for Follow-Up: Participants must be available for 6 months follow-up.

Exclusion Criteria:

1. Contaminated or Dirty Wounds: Patients with CDC Class III or IV wounds.
2. Immunocompromised Conditions: Patients on steroids, chemotherapy, or those with HIV.
3. Previous Midline Laparotomy with Incisional Hernia: Patients who have a history of incisional hernia after midline laparotomy.
4. Severe Malnutrition: Patients with BMI < 16 kg/m² or albumin < 2.5 g/dL.
5. Emergency Laparotomy with Hemodynamic Instability: Patients who are unstable or in a critical condition.
6. Pregnancy: Pregnant women.
7. Need for Temporary Abdominal Closure or Planned Reoperation: Patients requiring staged reoperation or temporary closure.

The individual participant data (IPD) that will be shared includes de-identified demographic information, surgical details, treatment outcomes, and relevant follow-up data (e.g., wound healing, incidence of complications, pain scores, and hernia occurrence). This will provide valuable insight into the comparative efficacy of polyglactin versus polypropylene sutures for rectus sheath closure. The data will be available to qualified researchers after the primary results have been published and the study is concluded.

The IPD and supporting information will be accessible to qualified researchers affiliated with academic, medical, or research institutions who are involved in the study of similar surgical outcomes or suture materials. These researchers will be able to access:

De-identified patient data (demographic, clinical outcomes, complications) Study protocol, SAP, ICF, CSR, and analytic code

Access will be granted through a secure online platform (such as a data repository) after a formal request and approval by the institution's data access committee. Researchers will be required to adhere to confidentiality agreements and data protection regulations.

This study is single-blind, meaning the participants do not know which suture material they received. The outcomes assessor (surgeon) will also be blinded to the group allocation to reduce bias in outcome assessment.