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Wound Closure Techniques in Primary Spine Surgery

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Mayo Clinic

Status

Enrolling

Conditions

Spinal Injuries

Treatments

Procedure: Closure technique

Study type

Interventional

Funder types

Other

Identifiers

NCT04396613
18-011744

Details and patient eligibility

About

The Researchers are trying to determine if there is a difference in blood flow around a wound site when comparing three different types of wound closure techniques.

Enrollment

147 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≥ 18 years old
  • Primary diagnosis of spinal stenosis
  • Surgical indication for 1 or 2 level posterior spinal decompression or fusion

Exclusion criteria

  • Pregnant or Breastfeeding
  • Previous posterior spinal surgery
  • Systemic corticosteroid use
  • Long-term anticoagulation treatment
  • Diagnosis of diabetes mellitus
  • Diagnosis of peripheral arterial disease
  • Current smoker
  • Active infection of any kind or chronic infection with HIV, Hepatitis C, or Syphilis
  • Iodine Allergy

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

147 participants in 3 patient groups

Running Subcuticular Suture
Active Comparator group
Treatment:
Procedure: Closure technique
Interrupted Vertical Mattress Suture
Active Comparator group
Treatment:
Procedure: Closure technique
Staple Closure Techniques
Active Comparator group
Treatment:
Procedure: Closure technique

Trial contacts and locations

1

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Central trial contact

Cassandra Willson

Data sourced from clinicaltrials.gov

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