Abdominal Surgery, Chronic Pain, Incisional Hernia, Rectus Sheath Closure, Surgical Site Infection (SSI), Wound Dehiscence
Conditions
Keywords
Polyglactin Sutures, Polypropylene Sutures, Non-Absorbable Sutures, Postoperative Complications, Midline Laparotomy
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREPolyglactin 910 (Vicryl) Suture
Polyglactin 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.
PROCEDUREPolypropylene (Prolene) Suture
Polypropylene (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.
Sponsors
Lady Reading Hospital, Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
This is a parallel-group design, where participants are assigned to one of two treatment arms (polyglactin or polypropylene). Both arms will undergo the same procedure but with different suture materials for rectus sheath closure.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incisional Hernia rate | 6 months postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infection (SSI) Rate | 30 days post-surgery | This outcome will measure the occurrence of any surgical site infection (SSI) within 30 days postoperatively. |
| Suture Sinus Formation | 6 months post-surgery | The occurrence of chronic draining tracts at the incision site, which are associated with the suture material. |
| Chronic Pain (Visual Analog Scale, VAS ≥4) | 3 months post-surgery | 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 | 30 days post-surgery | The occurrence of wound dehiscence, defined as partial or complete disruption of the rectus sheath, within 30 days post-surgery. |
Countries
Pakistan
Contacts
Primary ContactDr. Atta Ullah Arif Associate Professor, MBBS, FCPS
Outcome results
None listed