Introduction
Port-site hernias and incisional complications continue to challenge surgical teams despite advances in minimally invasive techniques. While general incidence rates hover around 0.1-0.5%, certain populations face dramatically higher risks.
Bariatric surgery patients experience port-site hernia rates of 3.2%, and umbilical extraction sites show rates as high as 21.5% in specific patient groups.
These complications highlight the importance of proper closure technique at multiple tissue layers. Securing the fascial layer prevents deep tissue herniation, while skin closure affects cosmetic outcomes and patient comfort.
This guide provides surgical teams with an overview of fascial closure device systems, instrument types, clinical indications, and a practical evaluation checklist for selecting the right tools.
TLDR:
- Port sites ≥10mm require fascial closure to prevent herniation; smaller ports may not need formal closure
- Fascial closure devices secure the deep tissue layer, preventing hernias before skin closure
- Main device categories: suture passers (Carter-Thomason), mechanical systems (Weck EFx), and barbed suture technology
- Barbed sutures reduce surgical site infections by 59% compared to conventional sutures
- Device selection should weigh clinical evidence, reliability, cost, and learning curve
Understanding Fascial Anatomy and Closure Principles
The fascial layer is a continuous connective tissue network that provides structural integrity to the abdominal wall. Unlike skin, which heals relatively quickly, fascia regains only approximately 50% of its original tensile strength by 2 months post-operation.
Complete remodeling takes over a year, making proper closure technique and device selection critical throughout the extended healing timeline.
Key Principles of Effective Fascial Closure:
- Tension distribution - Sutures or fasteners must distribute force evenly across the incision to prevent tissue strangulation and "buttonhole" hernias
- Tissue approximation - All fascial layers (peritoneum, muscle, and aponeurosis—the tough fibrous tissue covering) must be incorporated in the closure
- Suture strength retention - Materials must maintain tensile strength for at least 6-8 weeks during the critical healing phase
The European Hernia Society recommends the continuous "small-bites" technique for midline laparotomy closure: 5mm tissue bites spaced 5mm apart, achieving a suture-to-wound length ratio of at least 4:1. This approach reduces incisional hernia rates by 51% compared to traditional mass closure techniques.
Laparoscopic vs. Open Fascial Closure Considerations
These closure principles apply differently depending on surgical approach. Laparoscopic and open procedures present distinct fascial closure challenges.
Open surgery allows direct visualization and manual palpation of tissue layers, while laparoscopic closure must work through limited port access with restricted visualization.
Why Port Site Fascial Closure is Critical:
Port-site hernias occur when fascia fails to heal properly, allowing bowel or omentum to herniate through the defect. The risk is significant enough that closure protocols have become standardized.
Professional societies (EHS, SAGES) consistently recommend fascial closure for all ports ≥10mm and all umbilical/midline ports regardless of size due to elevated hernia risk.
The stakes are particularly high in bariatric surgery. A 2023 randomized trial found that closing lateral working ports increased postoperative pain (85.7% moderate pain vs. 5.7%) without significantly reducing hernia rates in the short term, highlighting the ongoing debate about closure protocols for non-midline ports in obese patients.
After fascial closure is complete, surgeons perform skin layer closure separately. This two-layer approach ensures both structural integrity and optimal cosmetic outcomes.
Types of Fascial Closure Devices and Systems
Suture-Based Fascial Closure Devices
Suture-based devices enable suture passage through fascia using specialized needles and guides. Surgeons favor these instruments for their versatility across port sizes and compatibility with preferred suture materials.
Carter-Thomason CloseSure System:
- Handheld suture grasper with needle-point jaws
- Pilot guides (5-15mm) angle suture for full-thickness closure including peritoneum
- Available in standard and XL lengths for obese patients (>5-7cm subcutaneous fat)
- FDA cleared under K980123
Endo Close (Medtronic):
- Spring-loaded blunt stylet with notched needle
- Stylet retracts to expose needle for suture capture
- Designed specifically for trocar site closure
VersaOne Fascial Closure System (Medtronic):
- Integrated trocar and closure system
- Cannula windows allow suture passage without removing port
- Maintains pneumoperitoneum during closure for continuous internal visualization
Advantages: Versatile, compatible with surgeon's preferred suture material, lower per-case cost
Limitations: Technique-dependent, learning curve for proper depth and angle, risk of visceral injury with blind passage
Mechanical Fascial Closure Systems
Mechanical systems use anchors, clips, or specialized deployment mechanisms to bring tissue together without traditional needle passing. These devices offer standardized closure depth and reduce sharps exposure risk.
Weck EFx (Teleflex):
- Suture passer with deployment wings and specific introducer
- Provides uniform 1cm fascial closure
- Designed to minimize sharps injury risk
neoClose (CooperSurgical):
- Uses bioabsorbable anchors with suture loop
- Achieves faster closure times (20.2s vs 30.0s in randomized trials)
- Reduces pain compared to standard suture passers
AbClose (Medeon Biodesign):
- Port site closure device cleared under FDA K193652
- Designed to reduce closure time and procedural risk
Advantages: Consistent closure depth, reduced sharps exposure, potentially faster deployment
Limitations: Higher per-case cost, limited suture material options, device-specific training required
Specialized Laparoscopic Fascial Closure Instruments
Dedicated laparoscopic devices address the unique challenges of working through limited port access with restricted visualization. These instruments extend the surgeon's reach while providing guidance for consistent fascial bite depth.
Key Design Features:
- Extended shaft length (standard and XL versions for bariatric patients)
- Integrated visualization aids (deployment wings, transparent components)
- Port-size-specific guides (10mm, 12mm, 15mm) to ensure proper bite distance from fascial edge
- Mechanisms to maintain pneumoperitoneum during closure
Learning Curve Considerations:
Specialized devices require structured training to master proper technique. Training should include:
- Hands-on practice with surrogate tissue models
- Understanding of device-specific failure modes
- Recognition of adequate tissue purchase through tactile feedback
- Confirmation of full-thickness closure including peritoneum
Barbed Suture Technology for Fascial Closure
Barbed (knotless) sutures feature directional barbs that anchor into tissue, eliminating knot tying and distributing tension more evenly along the suture line. This technology has gained traction as an alternative to both traditional sutures and mechanical closure devices.
Clinical Evidence:
A 2025 meta-analysis of 12,278 patients found barbed sutures significantly reduced surgical site infections (OR 0.41) compared to conventional sutures. A multicenter randomized trial in gynecologic laparotomy reported zero incisional hernias at 2 years with barbed sutures, though the difference versus conventional sutures was not statistically significant.
Advantages:
- Faster closure time (no knot tying)
- More uniform tension distribution
- Lower infection rates
- Reduced operative time
Limitations:
- Higher material cost per case
- Cannot be untied if adjustment needed
- Limited long-term hernia prevention data compared to traditional sutures
Instrument Types and Mechanisms of Action
Fascial closure instruments use four distinct mechanisms, each suited to different surgical scenarios and surgeon preferences.
Suture Passers:
- Needle-point jaws grasp and pass suture through tissue
- Demand manual dexterity for precise depth control
- Examples: Carter-Thomason, Endo Close
Needle Drivers:
- Adapted from standard laparoscopic drivers for fascial work
- Offer direct control but demand advanced suturing skills
Graspers:
- Capture and secure suture or tissue during closure
- Surgeons typically pair these with suture passers
- Enable precise tissue manipulation
Automated Devices:
- Pre-loaded mechanical systems that deploy via trigger
- Eliminate manual suture threading
- Examples: Weck EFx, neoClose
Beyond mechanism type, specific design features determine which instrument works best for each case.
| Feature | Impact on Selection |
|---|---|
| Needle size | Larger needles for thick fascia; smaller for pediatric cases |
| Shaft length | Standard (30-35cm) vs. XL (40-45cm) for obese patients |
| Jaw configuration | Affects tissue bite size and suture security |
| Ergonomics | Handle design impacts surgeon fatigue during multiple closures |
Selection Based on Surgical Approach:
- Single-site laparoscopy requires articulating instruments for parallel ports
- Multi-port laparoscopy uses standard straight instruments
- Port size: 5mm instruments for smaller channels; 10-12mm for larger ports
- Obese patients (BMI >35) need XL instruments to penetrate thick fascia
Clinical Indications by Surgical Specialty
General and Bariatric Surgery Applications
Laparoscopic Cholecystectomy:
- Typically uses 10-12mm umbilical port (requires closure) and three 5mm working ports (closure optional)
- Umbilical port closure is mandatory regardless of size due to high hernia risk at this location
Bariatric Procedures:
- Port-site hernia rates in bariatric surgery reach 3.2%, significantly higher than general laparoscopy
- Fascial closure is critical due to increased intra-abdominal pressure, tissue quality concerns, and larger port sizes
- Lateral port closure remains controversial—some evidence suggests it increases pain without reducing short-term hernia rates
Colorectal Surgery:
- Extraction sites (for specimen removal) require robust fascial closure due to larger defect size
- Hand-assist ports create larger fascial defects requiring careful layered closure
Gynecologic Surgery Indications
Laparoscopic Hysterectomy:
- All ports >5mm should undergo fascial closure to prevent bowel herniation
- Lateral ports must avoid inferior epigastric vessels; closure devices must span these vessels safely
Myomectomy:
- Port site selection depends on specimen size
- Morcellation ports or extension sites require careful fascial closure due to manipulation trauma
Port Site Selection Protocols:
- Primary visualization port: typically umbilical, 10-12mm (always close)
- Lateral working ports: placed lateral to rectus muscle to avoid vessels
- Suprapubic ports: often 5mm (closure protocol varies by institution)
Urologic and Thoracic Surgery Applications
Urologic Procedures:
- Robotic prostatectomy uses multiple 8mm ports plus 12mm assistant port (close ≥10mm ports)
- Nephrectomy ports undergo extensive manipulation; all ≥10mm ports require closure
- Hand-assist devices in donor nephrectomy create larger defects requiring layered closure
Thoracic Surgery (VATS):
- Port-site hernias are rare but serious; can lead to diaphragmatic hernias and bowel complications
- Ports low (near diaphragm) carry higher risk
- Extended ports for specimen extraction require careful closure
Specialty-Specific Guidelines:
Most urologic and thoracic societies follow the general ≥10mm threshold but emphasize the importance of closing any port that undergoes significant manipulation or extension during the procedure.
Comprehensive Evaluation Checklist for Selecting Fascial Closure Devices
When evaluating fascial closure devices for your institution, a systematic approach ensures you select systems that balance clinical effectiveness, safety, and operational efficiency. This checklist covers the critical factors across five key evaluation domains.
Device Performance and Technical Specifications
Start by assessing the fundamental technical capabilities that determine whether a device will reliably close fascial defects in your patient population.
Suture/Fastener Strength:
- ☐ Device accommodates suture material with appropriate tensile strength (minimum USP 0 or 2-0 for fascia)
- ☐ Suture or fastener maintains strength for 6-8 weeks minimum
- ☐ Material is slowly absorbable or permanent based on clinical indication
Device Reliability:
- ☐ Low reported failure rates in FDA MAUDE database
- ☐ Manufacturer provides failure mode analysis and mitigation strategies
- ☐ Device inspection protocols in place (check for bent needles, loose components)
Ease of Use:
- ☐ Intuitive mechanism requiring minimal steps
- ☐ Clear tactile feedback when proper tissue purchase achieved
- ☐ Ergonomic handle design reduces surgeon fatigue
Learning Curve:
- ☐ Training program available (hands-on, video, written materials)
- ☐ Estimated time to competency documented
- ☐ Proctoring or technical support available during initial cases
Port Size Compatibility:
- ☐ Device compatible with institution's standard port sizes (5mm, 10mm, 12mm, 15mm)
- ☐ Multiple guide sizes available for different port diameters
- ☐ Works with both bladed and bladeless trocars
Mechanism Type:
- ☐ Single-use vs. reusable clearly defined
- ☐ Automated vs. manual deployment matches surgeon preference
- ☐ Visualization requirements (works with or without pneumoperitoneum)
Clinical and Safety Considerations
Beyond technical performance, examine the clinical evidence and safety profile that will affect patient outcomes and institutional risk.
Regulatory Status:
- ☐ FDA 510(k) clearance verified for "fascial closure" or "trocar site closure" indication
- ☐ Regulatory clearance in all markets where device will be used
- ☐ Post-market surveillance data reviewed
Published Clinical Evidence:
- ☐ Peer-reviewed studies demonstrating efficacy
- ☐ Comparative data vs. standard closure techniques
- ☐ Long-term hernia rates documented (minimum 1-year follow-up)
Complication Rates:
- ☐ Device-related complication rates <1% in published literature
- ☐ Specific failure modes identified (breakage, inadequate tissue purchase, suture breakage)
- ☐ Visceral injury rates comparable to or lower than standard techniques
Patient Factor Suitability:
- ☐ Device performs adequately in obese patients (BMI >35)
- ☐ XL or extended-length version available for thick abdominal walls
- ☐ Effective in compromised tissue (previous surgery, infection, poor healing)
Economic and Operational Factors
The financial impact extends beyond device purchase price. Factor in time savings, training investments, and supply chain reliability.
Cost Analysis:
- ☐ Device cost per case documented
- ☐ Comparison to institution's current closure method cost
- ☐ Potential procedure time savings quantified (time = OR cost)
- ☐ Reusable vs. disposable economics analyzed (include reprocessing costs)
Training Costs:
- ☐ Initial training investment calculated (staff time, materials, proctoring fees)
- ☐ Ongoing education requirements identified
- ☐ Return on investment timeline estimated
Supply Chain Factors:
- ☐ Vendor reliability and track record verified
- ☐ Product availability and lead times confirmed
- ☐ Backup supplier or device identified in case of shortage
- ☐ Technical support availability (24/7 hotline, on-site representatives)
Surgeon and Team Preference Factors
Successful adoption depends on user acceptance. Devices that frustrate surgeons or disrupt OR workflow face implementation challenges regardless of clinical merit.
Ergonomics:
- ☐ Handle design comfortable for various hand sizes
- ☐ Activation force reasonable (not too stiff or too loose)
- ☐ Weight balanced for extended procedures
Tactile Feedback:
- ☐ Clear indication when needle has penetrated all tissue layers
- ☐ Resistance felt when suture is secured
- ☐ Distinct "click" or lock when device fully deployed
Visualization During Use:
- ☐ Device components visible laparoscopically during deployment
- ☐ Transparent or marked components aid in positioning
- ☐ Works well with angled (30° or 45°) laparoscopes
Workflow Integration:
- ☐ Compatible with existing OR setup and instrumentation
- ☐ Minimal disruption to established surgical flow
- ☐ Nursing and surgical tech staff comfortable with device preparation
Staff Adoption Potential:
- ☐ Surgeon champions identified to lead adoption
- ☐ Staff feedback incorporated into selection process
- ☐ Trial period planned with evaluation metrics defined
When evaluating bioabsorbable closure systems like SubQ It!, which holds FDA 510(k) clearance (K131563) for closing incisions in abdominal, thoracic, and gynecologic procedures, pay particular attention to absorption timeline data and cosmetic outcome studies. Bioabsorbable fastener systems eliminate staple removal visits while maintaining closure strength during the critical healing period.
Complications, Troubleshooting, and Best Practices
Common Device-Related Complications
| Complication | Incidence | Prevention Strategy |
|---|---|---|
| Device breakage | Rare (<0.5%) | Inspect instruments before use; follow manufacturer's single-use guidelines |
| Inadequate tissue purchase | 1-2% | Ensure needle fully penetrates peritoneum; use appropriate guide size for port diameter |
| Suture breakage | <1% | Use appropriate suture size (0 or 2-0 for fascia); avoid excessive tension |
| Fascial tearing | 1-3% | Take adequate tissue bites (5-10mm from edge); avoid tissue strangulation |
Understanding these failure modes helps prevent complications. FDA MAUDE data documents specific issues including suture passer tip breakage (Carter-Thomason) and component detachment (Weck EFx).
Rigorous device inspection and adherence to manufacturer guidelines significantly reduce these risks.
Best Practice Recommendations
Visual Confirmation Techniques:
- Maintain pneumoperitoneum during closure to visualize needle passage from inside
- Use angled laparoscope (30° or 45°) to confirm fascial approximation
- Look for symmetric tissue edges without gaps or overlapping
Suture Tension Guidelines:
- Avoid overtightening, which causes tissue ischemia and delayed healing
- Approximate fascia without strangulation
- Test tension by gently probing closed fascia with instrument
Port Site Closure by Size:
- <5mm ports: Generally do not require fascial closure (except in pediatric patients or very thin individuals)
- 5-9mm ports: Closure recommended for umbilical/midline locations; optional for lateral ports
- ≥10mm ports: Mandatory fascial closure regardless of location
- Extraction sites: Always close, often requiring layered closure technique
Troubleshooting Common Issues
Needle won't penetrate fascia:
- Verify correct guide size and ensure adequate pressure
- Consider switching to sharper needle device if resistance continues
Cannot visualize closure:
- Increase insufflation pressure temporarily
- Use device with transparent components or switch to device that maintains pneumoperitoneum
Suture pulls through tissue:
- Take larger tissue bites (8-10mm) and use stronger suture material
- Consider figure-of-eight technique for additional security
Device jams or fails to deploy:
- Stop immediately and remove device carefully
- Inspect for damage before using backup device
Frequently Asked Questions
What device is used to close fascia laparoscopically?
Suture passers like Carter-Thomason CloseSure and Endo Close are most common, using needle-point jaws to pass suture through fascia. Specialized systems like Weck EFx use deployment wings for uniform closure. Device selection depends on port size (10mm, 12mm, or 15mm), surgeon preference, and patient BMI.
How long does it take for a laparoscopic incision to close?
Surgical closure is immediate during the operation. Biological healing takes longer—fascial tissue regains 50% strength by 2 months and requires over a year for complete remodeling. Patients should avoid heavy lifting for 6-8 weeks to protect healing fascia.
What are the key differences between fascial closure devices for open versus laparoscopic surgery?
Laparoscopic devices must work through limited port access (5-15mm diameter) with restricted visualization, requiring extended shaft lengths and pilot guides. Open surgery instruments allow direct visualization and manual palpation without access constraints. Laparoscopic closure carries higher risk of blind visceral injury, making visualization aids critical.
When is fascial closure required in laparoscopic surgery?
Port sites ≥10mm require fascial closure according to professional society guidelines (EHS, SAGES). Umbilical and midline ports should be closed regardless of size due to elevated hernia risk. Ports <10mm generally don't require formal closure.
What are the most common causes of fascial closure device failure?
Device breakage (needle tips breaking off) occurs in <0.5% of cases from manufacturing defects or improper reuse. Inadequate tissue bite happens when needles don't fully penetrate peritoneum, often in obese patients. Technical errors include insufficient fascial bites, excessive tension, and blind passage injuring vessels. Minimize risks through proper device inspection and size selection.
How do you evaluate the quality of fascial closure intraoperatively?
Visual assessment is primary—maintain pneumoperitoneum and use an angled laparoscope to confirm symmetric fascial edges are approximated without gaps. Tactile evaluation involves probing closed fascia with a blunt instrument to ensure firm approximation without excessive tension. Before removing final ports, systematically inspect all closure sites from inside the abdomen.
