Pilonidal SinusNCT01081522
A Preliminary, Non-comparative Study to Evaluate a Bioresorbable Wound Scaffold in Acute Wounds
An observational study of Pilonidal Sinus, run by ConvaTec Inc. at 3 sites in 2 countries.
Trial summary
As this is a proof-of-concept study, the primary objective is to provide preliminary data on the safety and efficacy of Bioresorbable Wound Scaffold in the management of acute wounds left to heal by secondary intent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Sinus
- How many people
- 12 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2009to Feb 2010
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: secondary care clinics
Who may be able to join
- Subjects over 18 years, willing and able to provide written informed consent.
- Subjects who have an excised pilonidal sinus wound left to heal by secondary intent.
- Subjects who are willing to commit to having two biopsies being taken during the study.
Who cannot join
- Subjects with a history of skin sensitivity to any of the components of the study product
- Subjects whose wound is infected
- Subjects who have participated in a previous clinical study within the past 3 months
- Subjects' with a known history of poor compliance with medical treatments
- Subjects who are pregnant (where pregnancy is a possibility, a pregnancy testing kit will be provided)
- Necrotic/sloughy wounds unless surgically debrided prior to enrolment
Show all 9Show fewer
- Medical or emotional risk associated with the potential biopsy that outweighs the risk of not taking a biopsy as determined by the investigator
- Subjects exhibiting any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study
- Subjects with impaired renal function
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
Wound Healing Research Unit
Heathpark, Cardiff, CF 14 4XN
Scunthorpe General Hospital
Scunthorpe, North Lincolnshire, DN 15 7BH
About this study
As this is a proof-of-concept study, the primary objective is to provide preliminary data on the safety and efficacy of Bioresorbable Wound Scaffold in the management of acute wounds left to heal by secondary intent.
- Conditions
- Pilonidal Sinus
- Medical subject headings
- Pilonidal Sinus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startOct 2009
- Primary completionFeb 2010
- Study completionFeb 2010
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dheerendra Kommala, MD, Study director, ConvaTec Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081522
- Sponsor's protocol ID
- CW-0510-09-U352
- Status last verified
- Mar 2010
- First submitted
- 4 Mar 2010
- Last updated
- 5 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary, Non-comparative Study to Evaluate a Bioresorbable Wound Scaffold in Acute Wounds
- ClinicalTrials.gov ID
- NCT01081522
- Acronym / sponsor ID
- CW-0510-09-U352
- Conditions
- Pilonidal Sinus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 5 Mar 2010 (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.
As this is a proof-of-concept study, the primary objective is to provide preliminary data on the safety and efficacy of Bioresorbable Wound Scaffold in the management of acute wounds left to heal by secondary intent.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- secondary care clinics
Key inclusion criteria (3 listed)
- Subjects over 18 years, willing and able to provide written informed consent.
- Subjects who have an excised pilonidal sinus wound left to heal by secondary intent.
- Subjects who are willing to commit to having two biopsies being taken during the study.
Key exclusion criteria (9 listed)
- Subjects with a history of skin sensitivity to any of the components of the study product
- Subjects whose wound is infected
- Subjects who have participated in a previous clinical study within the past 3 months
- Subjects' with a known history of poor compliance with medical treatments
- Subjects who are pregnant (where pregnancy is a possibility, a pregnancy testing kit will be provided)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2010.
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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.
Dheerendra Kommala, MD study director
ConvaTec Inc.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilonidal Sinus, run by ConvaTec Inc. at 3 sites in 2 countries.
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 9 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: finished, as of the sponsor's last update on 5 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 5 Mar 2010.