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

NCT ID: NCT00292513

Last Updated: 2006-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rady Children's Hospital, San Diego

OTHER

Sponsor Role lead

Principal Investigators

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Bari B Cunningham, MD

Role: PRINCIPAL_INVESTIGATOR

Rady Children's Hospital, San Diego

Locations

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Children's Hospital San Diego

San Diego, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bari B Cunningham, MD

Role: CONTACT

[email protected]
858-576-1700 ext. 4270

Other Identifiers

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Dermabond Study

Identifier Type: -

Identifier Source: org_study_id