Pilonidal AbscessAROMANCT05154838
Development of Volatile Organic Compounds (VOC) Analysis as a Potential Diagnostic for Infected and Non-Healing Wounds
An observational study of Pilonidal Abscess and Non-healing Wound, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial summary
The study aims to assess the feasibility of detecting volatile organic compounds (VOCs) from pilonidal wound dressings to assemble a VOC profile for the assessment of wound healing trends. Non-healing wounds (NHWs) pose a significant burden to healthcare providers and to affected patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Abscess, Non-healing Wound
- What is being tested?
- Drainage and packing of pilonidal abscess
- Type of treatment
- Surgery or procedure
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jan 2022to 31 Mar 2023
- 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: All patients due to undergo acute surgical treatment for pilonidal sinus disease will be invited to participate in this study. A total of 12 patients will be recruited.
Who may be able to join
- Undergoing surgery for acute pilonidal abscess
- Aged 18 or over and able to give informed consent
Who cannot join
- Patients who are unwilling or unable to provide informed consent
- Patients who are unable to speak adequate English for informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to assess the feasibility of detecting volatile organic compounds (VOCs) from pilonidal wound dressings to assemble a VOC profile for the assessment of wound healing trends.
Non-healing wounds (NHWs) pose a significant burden to healthcare providers and to affected patients. Difficulties arise in the identification of wounds which are not on a healing trajectory. Early identification allows for proactive management to try and reduce healing time. Recent studies indicate that wound VOCs may have the potential to differentiate between healing and non-healing wounds. This study will use pilonidal abscesses for the analysis of wound VOC profiles using a non-invasive technique.
Read the detailed description
Non-healing wounds (NHWs) are a worldwide and costly problem. Although NHWs are relatively small in number, the cost associated for care and product use is disproportionately high. A recent study from the United Kingdom suggests that wound care accounts for an estimated £8.3bn, or approximately 5.5% of total NHS healthcare costs (Guest 2017). NHWs can cause pain, stress, isolation, odour, and decreased mobility for the patients and, if the wound remains after more than 12-24 months, further surgery is required which may be radical and disfiguring.
Emergency presentation of pilonidal abscess requires hospitalisation with incision and drainage of the abscess cavity. Complete healing occurs in 60% of patients (Deans GT 1998) and one in five patients represent with recurrent symptoms following emergency surgery (Jensen 1988). Infection and wound breakdown after elective surgery is also relatively common affecting 10-15% of patients (Spivak H 1996), making it a good candidate to studying non-healing wounds.
Patients over the age of 18 who are admitted to hospital with a pilonidal abscess which requires drainage will be eligible for the study. The patient will undergo the standard procedure to drain an abscess, during which time wound swabs will be collected. Additional swabs will be collected for participants in this study, compared to routine care. The wound will be dressed as standard and the same dressing is applied to an area of un-affected skin on the buttock. The dressings are changed the following day, and are handled in such a way that VOC are released and captured from the dressings. These VOC will be sent for analysis using specialist equipment, which will identify VOC profiles that are unique to each sample. Participants will be followed up 30 days later after treatment to assess the wound-healing status, which will in turn be linked back to the VOC profile in order to determine whether associations can be made between the two. The study aims to recruit 12 patients over a 12 month period.
- Conditions
- Pilonidal Abscess, Non-healing Wound
- Being tested
- Drainage and packing of pilonidal abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drainage and packing of pilonidal abscessProcedure or surgery
Patients will be treated as per standard care, their wound drained, cleaned and packed. Microbiology swab samples will be obtained.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Pilonidal Abcess | All adult (18+) patients presenting at surgical assessment unit requiring treatment for pilonidal abscess. Wounds will be drained, cleaned and packed as per usual clinical practice. Extra standard wound swabs will be collected for additional microbiological analyses. Control wound dressings will be placed on adjacent, unaffected area of skin for 24 hours. Receives: Procedure: Drainage and packing of pilonidal abscess |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volatile Organic Compound detection
Feasibility of detecting VOC from pilonidal wound dressings as determined by mass-spec
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start19 Jan 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal AbscessStudies 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Collaborators
- Cardiff Metropolitan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154838
- Sponsor's protocol ID
- 7864
- Other IDs
- 302788
- Acronym
- AROMA
- Status last verified
- Mar 2022
- First submitted
- 30 Nov 2021
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Volatile Organic Compounds (VOC) Analysis as a Potential Diagnostic for Infected and Non-Healing Wounds
- ClinicalTrials.gov ID
- NCT05154838
- Acronym / sponsor ID
- AROMA / 7864
- Conditions
- Pilonidal Abscess, Non-healing Wound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Collaborators
- Cardiff Metropolitan University
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 13 Dec 2021 (actual)
- 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.
The study aims to assess the feasibility of detecting volatile organic compounds (VOCs) from pilonidal wound dressings to assemble a VOC profile for the assessment of wound healing trends.
Non-healing wounds (NHWs) pose a significant burden to healthcare providers and to affected patients. Difficulties arise in the identification of wounds which are not on a healing trajectory. Early identification allows for proactive management to try and reduce healing time. Recent studies indicate that wound VOCs may have the potential to differentiate between healing and non-healing wounds. This study will use pilonidal abscesses for the analysis of wound VOC profiles using a non-invasive technique.
Detailed description
Non-healing wounds (NHWs) are a worldwide and costly problem. Although NHWs are relatively small in number, the cost associated for care and product use is disproportionately high. A recent study from the United Kingdom suggests that wound care accounts for an estimated £8.3bn, or approximately 5.5% of total NHS healthcare costs (Guest 2017). NHWs can cause pain, stress, isolation, odour, and decreased mobility for the patients and, if the wound remains after more than 12-24 months, further surgery is required which may be radical and disfiguring.
Emergency presentation of pilonidal abscess requires hospitalisation with incision and drainage of the abscess cavity. Complete healing occurs in 60% of patients (Deans GT 1998) and one in five patients represent with recurrent symptoms following emergency surgery (Jensen 1988). Infection and wound breakdown after elective surgery is also relatively common affecting 10-15% of patients (Spivak H 1996), making it a good candidate to studying non-healing wounds.
Patients over the age of 18 who are admitted to hospital with a pilonidal abscess which requires drainage will be eligible for the study. The patient will undergo the standard procedure to drain an abscess, during which time wound swabs will be collected. Additional swabs will be collected for participants in this study, compared to routine care. The wound will be dressed as standard and the same dressing is applied to an area of un-affected skin on the buttock. The dressings are changed the following day, and are handled in such a way that VOC are released and captured from the dressings. These VOC will be sent for analysis using specialist equipment, which will identify VOC profiles that are unique to each sample. Participants will be followed up 30 days later after treatment to assess the wound-healing status, which will in turn be linked back to the VOC profile in order to determine whether associations can be made between the two. The study aims to recruit 12 patients over a 12 month period.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Pilonidal Abcess | – | Procedure: Drainage and packing of pilonidal abscessAll adult (18+) patients presenting at surgical assessment unit requiring treatment for pilonidal abscess. Wounds will be drained, cleaned and packed as per usual clinical practice. Extra standard wound swabs will be collected for additional microbiological analyses. Control wound dressings will be placed on adjacent, unaffected area of skin for 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients due to undergo acute surgical treatment for pilonidal sinus disease will be invited to participate in this study. A total of 12 patients will be recruited.
Key inclusion criteria (2 listed)
- Undergoing surgery for acute pilonidal abscess
- Aged 18 or over and able to give informed consent
Key exclusion criteria (2 listed)
- Patients who are unwilling or unable to provide informed consent
- Patients who are unable to speak adequate English for informed consent
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 |
|---|---|---|
| Drainage and packing of pilonidal abscessPatients will be treated as per standard care, their wound drained, cleaned and packed. Microbiology swab samples will be obtained. | Procedure or surgery | Patients with Pilonidal Abcess |
Primary outcome
Volatile Organic Compound detection
Time frame: 12 months
Feasibility of detecting VOC from pilonidal wound dressings as determined by mass-spec
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 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Pilonidal Abscess
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SiLaC Laser Technique for Pilonidal Sinus - La Paz Cohort Study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilonidal Abscess and Non-healing Wound, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
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 2 inclusion and 2 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 Apr 2023. 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 Kingdom. 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.
What does the primary outcome measure?
Volatile Organic Compound detection (time frame: 12 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 5 Apr 2023.