Fasciotens®: in-depth overview

1. Open abdomen treatment, often after severe abdominal infection, trauma, abdominal compartment syndrome, or damage-control surgery.
2. Very large or complex ventral/incisional hernias, especially when the abdominal contents cannot be returned and the abdominal wall closed without excessive tension.

Why an open abdomen becomes hard to close

• The two fascial edges retract laterally.
• The abdominal wall shortens and stiffens.
• The capacity of the abdominal cavity decreases relative to the volume of its contents.
• Attempting forceful closure can raise intra-abdominal pressure and risk recurrent abdominal compartment syndrome.
• A prolonged open abdomen increases risks such as adhesions, fistula, infection, loss of abdominal domain, and later incisional hernia.

Mechanism: controlled vertical fascial traction

• Counteracts lateral fascial retraction.
• Gradually stretches the abdominal wall.
• May increase functional intra-abdominal volume.
• Reduces the distance between the fascial edges over time.
• Can make direct closure more feasible once edema, sepsis, and physiologic instability have improved.

Main clinical settings

1. Open abdomen

• Abdominal compartment syndrome or marked intra-abdominal hypertension
• Severe peritonitis or uncontrolled intra-abdominal sepsis
• Major abdominal trauma and damage-control laparotomy
• Acute pancreatitis with severe edema or compartment physiology
• Massive visceral edema after resuscitation or vascular surgery

2. Complex incisional or ventral hernia

Typical treatment pathway

1. Stabilize the patient and treat the cause
   Control hemorrhage, contamination, sepsis, ischemia, edema, or compartment syndrome.
2. Protect the abdominal contents
   Use a temporary abdominal closure method, commonly negative-pressure wound therapy.
3. Apply controlled fascial traction
   The device is positioned to transmit traction through the fascia and abdominal wall under specialist supervision.
4. Reassess at planned re-look operations
   The surgeon evaluates visceral edema, fascial distance, bowel viability, contamination, wound status, and intra-abdominal pressure.
5. Perform delayed primary fascial closure when safe
   Closure may occur without mesh, with mesh augmentation, or with another reconstructive technique if direct closure remains unsuitable.

Evidence and expected outcomes

• Mean initial fascial separation was 15 cm.
• At 48 hours, it fell to 10 cm.
• Primary fascial closure was achieved at a mean of 7 days.
• The study included 20 patients and had no control group.

What can reasonably be concluded

Risks and limitations

• Pressure injury or skin breakdown at contact points
• Excessive traction causing fascial or muscle injury
• Pain or discomfort, especially in awake patients
• Increased intra-abdominal pressure if closure or tension is inappropriate
• Hernia recurrence or abdominal-wall weakness
• Surgical-site infection, seroma, hematoma, or wound complications
• Failure to obtain primary closure, requiring mesh, component separation, staged reconstruction, or a planned ventral hernia

Key practical point

Fasciotens® Abdomen

Indications

• Prevent lateral fascial retraction during open-abdomen treatment.
• Gradually stretch abdominal wall/fascia where there is current or previous loss of abdominal-wall domain or fascial tissue.
• Facilitate delayed primary fascial closure after:
  • Abdominal compartment syndrome or intra-abdominal hypertension
  • Severe peritonitis or intra-abdominal sepsis
  • Damage-control laparotomy for trauma
  • Marked visceral/abdominal-wall edema, such as severe acute pancreatitis
  • Other situations where the abdomen cannot initially be closed safely

Practical steps: high-level workflow

1. Confirm indication and stabilize the patient
   • Control bleeding, contamination, ischemia, sepsis, and fluid overload.
   • Confirm that immediate fascial closure would be unsafe or impossible.
   • Assess abdominal pressure, bowel edema, tissue viability, and planned re-look timing.
2. Prepare the open abdomen
   • Protect intra-abdominal contents with an appropriate temporary abdominal-closure system.
   • Commonly combine with negative-pressure wound therapy (NPWT) to manage fluid and reduce adhesions.
3. Expose and prepare viable fascial margins
   • Ensure the fascia can safely hold traction sutures.
   • The IFU specifies braided USP 2 suture material for secure retention in the device frame.
4. Place traction sutures
   • Sutures are placed symmetrically in the fascial margins, often through mesh strips according to the device protocol.
   • Sutures are connected to the device's retention frame with balanced baseline tension.
5. Position the device
   • The Fasciotens Abdomen support feet are placed on the thorax and anterior pelvic ring.
   • Use broad, wrinkle-free padding over intact skin.
   • Ensure no cables, electrodes, tubes, feeds, drains, or other objects are trapped beneath the support surfaces.
   • Never position it over the genitalia.
6. Apply controlled vertical traction
   • Set traction gradually and equally across the sutures using the device adjustment mechanism.
   • Confirm the frame is aligned parallel to the laparostoma.
   • Do not create excessive diagonal pull, because this can raise intra-abdominal pressure or risk abdominal-organ injury if a suture fails.
7. ICU monitoring and reassessment
   • Regularly reassess traction force, skin beneath supports, pain/sedation needs, ventilation, urine output, perfusion, and intra-abdominal pressure where clinically indicated.
   • The quick guide recommends traction intervals of roughly 5 hours followed by a 1-hour break to reduce skin irritation, with regular force checks. Quick guide
8. Planned re-look operation
   • Remove the nonsterile device before entering the sterile field.
   • Reassess bowel, source control, edema, fascial separation, and ability to close.
   • Readjust traction or proceed to delayed primary fascial closure when physiologically safe.
9. Definitive closure
   • Close fascia without undue tension when possible.
   • If closure remains unsafe, continue staged management or use another reconstructive option such as mesh augmentation, component separation, or planned ventral hernia as clinically appropriate.

Contraindications

Do not use / avoid use in these situations

• No open abdomen or no appropriate fascial indication
  Fasciotens Abdomen is intended for an open abdomen, not other anatomical structures or unrelated procedures.
• Inability to obtain safe fascial fixation
  Examples: severely necrotic, friable, infected, or insufficient fascia that cannot securely retain traction sutures.
• Unsafe external support sites
  • Non-intact skin, burns, infected wounds, pressure injury, or severe trauma over the thorax or anterior pelvic ring
  • Inability to safely place and pad the support surfaces
  • Device must not rest on the genitalia
• A patient who cannot tolerate traction
  • Traction that would worsen intra-abdominal hypertension or precipitate/recur abdominal compartment syndrome
  • Worsening respiratory mechanics, venous return, organ perfusion, or hemodynamic instability attributable to traction
• Uncontrolled intra-abdominal pathology requiring urgent re-exploration
  • Ongoing bleeding
  • Uncontrolled contamination or sepsis
  • Suspected bowel ischemia/perforation
  • Any condition where traction would delay necessary surgical source control
• Damaged packaging or damaged device
  • A visibly damaged sterile package should not be used.
  • Defective components that could endanger the patient or staff require device replacement.

Important relative cautions

• Marked skin fragility or high pressure-injury risk
• Extreme obesity or anatomy that prevents stable, safe positioning
• Severe coagulopathy or high risk of bleeding from suture placement
• Significant fascial weakness where traction may cause tearing
• Severe abdominal-wall infection
• Inadequate staff expertise or inability to monitor traction and skin condition in ICU