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.
Age: 18-70 years.
Type of Surgery: Patients undergoing elective or emergency midline laparotomy.
Wound Classification: Clean or clean-contaminated wounds (CDC Class I or II).
Ability to Provide Informed Consent: Participants must be able to understand and sign the informed consent form.
Contaminated or Dirty Wounds: Patients with CDC Class III or IV wounds.
Immunocompromised Conditions: Patients on steroids, chemotherapy, or those with HIV.
Previous Midline Laparotomy with Incisional Hernia: Patients who have a history of incisional hernia after midline laparotomy.
Severe Malnutrition: Patients with BMI < 16 kg/m² or albumin < 2.5 g/dL.
Parallel
Polyglactin 910 (Vicryl) Suture
Procedure/SurgeryPolyglactin 910 (Vicryl) is an absorbable synthetic multifilament suture material used for rectus sheath closure following laparotomy. This suture material undergoes hydrolytic degradation over a period of 56-70 days and retains approximately 75% of its tensile strength at 2 weeks and 50% at 3 weeks, which aligns with the typical biological timeline for fascial healing. It is used to approximate the anterior rectus sheath with a continuous suturing technique.
Polypropylene (Prolene) Suture
Procedure/SurgeryPolypropylene (Prolene) is a non-absorbable monofilament suture material used for rectus sheath closure following laparotomy. It provides long-term mechanical support for abdominal wall closure and does not degrade over time. The suture material maintains its tensile strength indefinitely and is known for its high biocompatibility, minimal tissue reaction, and resistance to infection due to its monofilament structure. It is applied using a continuous suturing technique.
Incisional Hernia rate
The primary outcome will assess the rate of incisional hernia at 6 months post-surgery in patients who undergo rectus sheath closure with either Polyglactin 910 (Vicryl) or Polypropylene (Prolene) sutures.
Surgical Site Infection (SSI) Rate
This outcome will measure the occurrence of any surgical site infection (SSI) within 30 days postoperatively.
Suture Sinus Formation
The occurrence of chronic draining tracts at the incision site, which are associated with the suture material.
Chronic Pain (Visual Analog Scale, VAS ≥4)
The presence of chronic pain at the surgical site lasting more than 3 months postoperatively, assessed using the Visual Analog Scale (VAS), where the VAS is a 10-point scale ranging from 0 (no pain) to 10 (worst possible pain). A score of 4 or higher indicates the presence of clinically significant chronic pain.
Wound Dehiscence
The occurrence of wound dehiscence, defined as partial or complete disruption of the rectus sheath, within 30 days post-surgery.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
