Pilonidal SinusNCT00493493
Pore Excision, Curettage, and Injection of Cymetra for Pilonidal Disease
A study testing surgery (Pore Excision, Curettage, and Injection of Cymetra) in people with Pilonidal Sinus, run by Matino, James, M.D. at 1 site in United States.
Trial summary
Chronic pilonidal disease is a common problem with no ideal treatment. This is a prospective study that will evaluate the results of surgical pore excision, curettage, and injection of a regenerative tissue matrix, Cymetra, on patients with chronic pilonidal disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- surgery (Pore Excision, Curettage, and Injection of Cymetra)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jun 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any patient with pilonidal diseas
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
St Francis Hospital
Hartford, Connecticut, 06105
About this study
Official title: Pore Excision, Curettage, and Injection of a Tissue Scaffold as Treatment for Pilonidal Disease
Chronic pilonidal disease is a common problem with no ideal treatment. This is a prospective study that will evaluate the results of surgical pore excision, curettage, and injection of a regenerative tissue matrix, Cymetra, on patients with chronic pilonidal disease.
Read the detailed description
In addition, the study will evaluate the credibility and reproducibility of results within other surgeons trained to perform the procedure. Data collection will focus on post-operative wound failure, infection ratwes, analgesic requirements, time lost from work or school, wound care requirements, and 6 month recurrence rates. These outcomes will be compared to outcomes using conventional pilonidal surgical intervention using published data.
- Conditions
- Pilonidal Sinus
- Being tested
- surgery (Pore Excision, Curettage, and Injection of Cymetra)
- Keywords
- Cymetra
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery (Pore Excision, Curettage, and Injection of Cymetra)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
wound failure, time lost from work or school, analgesic requirements, recurrence rates
Measured: 6 months
Secondary outcomes (1)
infection rates, wound care requirements
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startJan 2007
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal SinusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matino, James, M.D.
- Collaborators
- LifeCell
- Investigators
- James J Matino, MD, Principal investigator, Surgical Group,PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493493
- Sponsor's protocol ID
- Pilonidal/Cymetra
- Status last verified
- Jun 2007
- First submitted
- 27 Jun 2007
- Last updated
- 28 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pore Excision, Curettage, and Injection of a Tissue Scaffold as Treatment for Pilonidal Disease
- ClinicalTrials.gov ID
- NCT00493493
- Acronym / sponsor ID
- Pilonidal/Cymetra
- Conditions
- Pilonidal Sinus
- Keywords
- Cymetra
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Matino, James, M.D.
- Collaborators
- LifeCell
- Study start
- Jan 2007
- Study completion
- Jun 2008 (estimated)
- First posted
- 28 Jun 2007 (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.
Chronic pilonidal disease is a common problem with no ideal treatment. This is a prospective study that will evaluate the results of surgical pore excision, curettage, and injection of a regenerative tissue matrix, Cymetra, on patients with chronic pilonidal disease.
Detailed description
In addition, the study will evaluate the credibility and reproducibility of results within other surgeons trained to perform the procedure. Data collection will focus on post-operative wound failure, infection ratwes, analgesic requirements, time lost from work or school, wound care requirements, and 6 month recurrence rates. These outcomes will be compared to outcomes using conventional pilonidal surgical intervention using published data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient with pilonidal diseas
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| surgery (Pore Excision, Curettage, and Injection of Cymetra) | Procedure or surgery | – |
Primary outcome
wound failure, time lost from work or school, analgesic requirements, recurrence rates
Time frame: 6 months
1 secondary outcome
infection rates, wound care requirements
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2007.
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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.
James J Matino, MD principal investigator
Surgical Group,PC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery (Pore Excision, Curettage, and Injection of Cymetra) in people with Pilonidal Sinus, run by Matino, James, M.D. 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 1 inclusion and 0 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 28 Jun 2007. 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 James J Matino, MD (860-249-8595, jimanderin@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound failure, time lost from work or school, analgesic requirements, recurrence rates (time frame: 6 months). It is what the study was designed to measure, not a finding.
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 28 Jun 2007.