Cyst of Face, Neck or ShoulderNCT00292513
Clinical Trial Comparing Tissue Adhesive Vs. Absorbable Suture Vs. Non-Absorbable Suture
A study testing standard suture (5-0 prolene), topical skin adhesive (dermabond), absorbable suture (5-0 Chromic gut) in people with Cyst of Face, Neck or Shoulder and Pilomatrixoma of Face, Neck or Shoulder, run by Rady Children's Hospital, San Diego at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Cyst of Face, Neck or Shoulder, Pilomatrixoma of Face, Neck or Shoulder
- What is being tested?
- standard suture (5-0 prolene), topical skin adhesive (dermabond), absorbable suture (5-0 Chromic gut)
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital San Diego
San Diego, California, 92123
Bari B Cunningham, MD
Sheila F Friedlander, MD
About this study
Official title: A Randomized Clinical Trial Comparing Tissue Adhesive (2-Octylcyanoacrylate) Vs. Absorbable Suture Vs. Non-Absorbable Suture for the Closure of Low Tension Facial and Neck Wounds in Children and Adolescents
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
- Being tested
- standard suture (5-0 prolene), topical skin adhesive (dermabond), absorbable suture (5-0 Chromic gut)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard suture (5-0 prolene), topical skin adhesive (dermabond), absorbable suture (5-0 Chromic gut)Device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyst of Face, Neck or ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Rady Children's Hospital, San Diego
- Sponsor type
- University, hospital or other
- Investigators
- Bari B Cunningham, MD, Principal investigator, Rady Children's Hospital, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292513
- Sponsor's protocol ID
- Dermabond Study
- Status last verified
- May 2005
- First submitted
- 15 Feb 2006
- Last updated
- 16 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Tissue Adhesive (2-Octylcyanoacrylate) Vs. Absorbable Suture Vs. Non-Absorbable Suture for the Closure of Low Tension Facial and Neck Wounds in Children and Adolescents
- ClinicalTrials.gov ID
- NCT00292513
- Acronym / sponsor ID
- Dermabond Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Rady Children's Hospital, San DiegoUniversity, hospital or other
- First posted
- 16 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard suture (5-0 prolene), topical skin adhesive (dermabond), absorbable suture (5-0 Chromic gut) | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2006.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bari B Cunningham, MD principal investigator
Rady Children's Hospital, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard suture (5-0 prolene), topical skin adhesive (dermabond), absorbable suture (5-0 Chromic gut) in people with Cyst of Face, Neck or Shoulder and Pilomatrixoma of Face, Neck or Shoulder, run by Rady Children's Hospital, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bari B Cunningham, MD (858-576-1700 ext. 4270, bcunningham@chsd.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2006.