Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery

Conditions

• C.Surgical Procedure; Disruption of Wound, Suture

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Stratafix suture — DEVICE
  Stratafix symmetric suture
• Standard of care suture — DEVICE
  Standard of care suture

Study Details

Comparing the use of Stratafix Symmetric™ sutures to standard laparotomy closure sutures.

Key Dates

Start date

Dec 1, 2023

Status verified

Jan 2024

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Stratafix Group
  Stratafix
• Placebo Comparator: Control Group
  Standard of care

Primary Outcome Measure

Number of participants who develop ventral incisional hernia [ Time Frame: From enrollment to end of study participation at 12 months ]

Central Contacts

• Wendi Mitchell
  269-373-7443
  [email protected]

Locations (1)

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