Comparison of Vicryl Versus Prolene Sutures in Closure of Midline Rectus Sheath Following Elective Laparotomy: A Randomized Controlled Trial
Phase: NA
Conditions: Laparotomy Closure After Abdominal Surgery, Suture Materials, Complications Wounds
Sponsor: Hayatabad Medical Complex

Study Protocol 
Official Study Title 
Comparison of Vicryl Versus Prolene for Midline Rectus Sheath Closure After Elective 
Laparotomy 
Brief Title 
Comparison of Vicryl Versus Prolene for Midline Rectus Sheath Closure 
ClinicalTrials.gov Identifier 
NCT Number: Not yet assigned 
Unique Protocol ID 
HMC-RECTUS-2019 
Study Type 
Randomized Controlled Trial (RCT) 
Study Sponsor / Conducting Institution 
Hayatabad Medical Complex (HMC) 
Peshawar, Pakistan 
Responsible Party: 
Principal Investigator 
Principal Investigator: 
Dr. Gohar Ali 
Principal Investigator 
Department of Surgery 
Hayatabad Medical Complex, Peshawar, Pakistan 
Study Document 
Study Protocol 
Ethics Approval: 
Approved by Ethical Committee, Hayatabad Medical Complex, Peshawar 
Approval Number: HMC-QAD-F No. IREB-1680 
Recruitment & Study Duration: 
• Estimated Enrollment: 152 participants 
• Study Start Date: April 2024 
• Primary Completion Date: October 2024 
• Study Completion Date: October 2024 
Study document date: May 5, 2024 

 
Comparison of Vicryl Versus Prolene for Midline Rectus Sheath Closure After Elective 
Laparotomy 
Brief Summary: 
This study aims to compare the incidence of surgical site complications, including Surgical site 
infections (SSI) and wound dehiscence following midline rectus sheath closure using either 
polyglactin 910 (Vicryl®) or polypropylene (Prolene®) in elective laparotomy. The study will 
evaluate outcomes over a 30-day postoperative follow-up period. 
Objectives: 
• Primary Objective: 
To compare the rate of SSI between patients undergoing midline rectus sheath closure 
with Vicryl® versus Prolene® sutures. 
• Secondary Objectives: 
To compare the Incidence of Wound dehiscence within 30 days 
Postoperative pain, assessed using the Visual Analog Scale (VAS). 
Other complications. 
 
Background & Rationale: 
Abdominal wall closure technique and choice of suture material play a crucial role in 
determining postoperative outcomes following laparotomy. Previous studies have reported 
variable rates of SSI and wound dehiscence and others complications depending on the type of 
suture material used. However, evidence remains inconsistent regarding the optimal suture 
choice for elective midline laparotomy closure. 
This randomized controlled trial is designed to evaluate whether Vicryl® (delayed absorbable) or 
Prolene® (non-absorbable) sutures provide superior clinical outcomes, thereby guiding 
evidence-based surgical practice. 
Study Design: 
• 
Interventional, randomized, parallel-group, open-label clinical trial study. 
• 
Allocation: Randomized 1:1 to either Vicryl® or Prolene®. 
• 
Number of Arms: 2 
Arms & Interventions: 
1. Vicryl Arm: Midline rectus sheath closure performed using polyglactin 910 (Vicryl®) 
suture with a continuous mass closure technique. 
2. Prolene Arm: Midline rectus sheath closure performed using polypropylene (Prolene®) 
suture with a continuous mass closure technique. 
Outcome Measures: 

• 
Primary Outcome: SSI within 30 days postoperatively. 
• 
Secondary Outcomes: Incidence of wound dehiscence, postoperative pain (VAS scale), 
incidence of incisional hernia at 30 days. 
Eligibility Criteria: 
Inclusion Criteria: 
• 
Age 18 to 70 years 
• 
Patients undergoing elective midline laparotomy 
• 
Ability to provide written informed consent 
Exclusion Criteria: 
• 
Emergency laparotomy 
• 
Previous abdominal mesh placement 
• 
Immunocompromised patients 
• 
Pregnant women 
Ethics: 
• 
Approved by Institutional Review Board, HMC (HMC-QAD-F No. IREB-1680) 
• 
Written informed consent obtained from all participants 
Data Management: 
• 
Data recorded in secured database and standardized proforma 
• 
Patient identifiers removed for any shared datasets. 
• 
SPSS V23. Is used for data entry.  
 
References: 
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continuous and interrupted fascial closure in emergency midline laparotomy at a tertiary care 
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2. 
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ECLAPTE: Effective Closure of LAParoTomy in Emergency—2023 World Society of 
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3. 
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7. 
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8. 
Helgeland J, Tomic O, Hansen TM, Kristoffersen DT, Hassani S, Lindahl AK. 
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9. 
Patel SV, Paskar DD, Nelson RL, Vedula SS, Steele SR. Closure methods for laparotomy 
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10. 
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11. 
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12. 
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13. 
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Non-absorbable Polypropylene (Prolene®) and Delayed Absorbable Polyglactin 910 (Vicryl®) 
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