Comparing Polyglactin vs Polypropylene Sutures for Rectus Sheath Closure (PolySuture)

Lady Reading Hospital, Pakistan

Status: Begins enrollment in 1 month

Conditions: Rectus Sheath Closure; Incisional Hernia; Wound Dehiscence; Chronic Pain; Abdominal Surgery; Surgical Site Infection (SSI)

Treatments: Procedure: Polypropylene (Prolene) Suture; Procedure: Polyglactin 910 (Vicryl) Suture

Study type: Interventional

Funder types: Other

Identifiers

NCT07280975

563/LRH/MTI

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 2 patient groups

Polyglactin 910 (Vicryl) Suture for Rectus Sheath Closure

Experimental group

Description:

In this arm, participants will undergo rectus sheath closure using polyglactin 910 (Vicryl), a synthetic absorbable braided suture. This material is designed to provide temporary wound support during the healing process, with predictable hydrolytic degradation over 56-70 days. The intervention involves continuous suturing of the rectus sheath, with the suture size being 1 (USP). The primary aim is to evaluate postoperative outcomes such as incisional hernia, surgical site infections, wound dehiscence, and chronic pain, using polyglactin sutures for abdominal wall closure.Polyglactin 910 (Vicryl) Suture for Rectus Sheath Closure

Treatment:

Procedure: Polyglactin 910 (Vicryl) Suture

Polypropylene (Prolene) Suture for Rectus Sheath Closure

Active Comparator group

Description:

In this arm, participants will undergo rectus sheath closure using polypropylene (Prolene), a non-absorbable monofilament suture. Polypropylene is known for its high tensile strength and biocompatibility, providing long-term mechanical support without being absorbed by the body. The intervention will involve continuous suturing of the rectus sheath, using a size 1 (USP) suture. The main focus will be to assess the incidence of complications such as incisional hernia, surgical site infection, wound dehiscence, and chronic pain following closure with polypropylene sutures.

Treatment:

Procedure: Polypropylene (Prolene) Suture