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Clinical Trial Comparing Tissue Adhesive Vs. Absorbable Suture Vs. Non-Absorbable Suture

R

Rady Children's Hospital

Status

Unknown

Conditions

Cyst of Face, Neck or Shoulder
Pilomatrixoma of Face, Neck or Shoulder

Treatments

Device: standard suture (5-0 prolene), topical skin adhesive (dermabond), absorbable suture (5-0 Chromic gut)

Study type

Interventional

Funder types

Other

Identifiers

NCT00292513
Dermabond Study

Details and patient eligibility

About

Standard suture is superior to both tissue adhesive (2-octyl cyanoacrylate) and absorbable sutures with respect to cosmetic outcome of, complication rate of and parental satisfaction with the closure of low tension facial, neck and shoulder, wounds in children and adolescents

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age less than or equal to 18
  • Pre-operative diagnosis of cyst or pilomatrixoma of neck, face or shoulder
  • outpatient scheduled for outpatient or day surgery at Children's Hospital San Diego

Exclusion criteria

  • known hypersensitivity to cyanoacrylate or formaldehyde
  • lesions with any evidence of active infection or gangrene
  • lesions on or across mucocutaneous surfaces
  • lesions in which skin may be regularly exposed to body fluids
  • lesions located in areas of dense natural hair (ie scalp)
  • patients with peripheral vascular disease, insulin dependent diabetes mellitis or blood clotting disorders
  • patients with known immunodeficiencies
  • inability to return for follow-up

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Bari B Cunningham, MD

Data sourced from clinicaltrials.gov

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