Perianal AbscessPPACNCT01739478
Packing of Perianal Abscess Cavities Trial: A Randomised Multicentre Trial Comparing Packing With Non-packing of the Abscess Cavity
A study testing Packing of abscess cavity and External dressing in people with Perianal Abscess, run by North Western Research Collaborative.
Trial summary
The aim of this study is to compare the effect of packing and non-packing on the healing rate of perianal abscess cavities. Secondary objectives are to assess quality of life, cost effectiveness and rate of abscess recurrence and fistula-in-ano formation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perianal Abscess
- What is being tested?
- Packing of abscess cavity and External dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of acute primary perianal abscess
- Have undergone surgical incision and drainage as an emergency
Who cannot join
- The abscess is the sequelae of concurrent disease or trauma
- Fourniers gangrene is suspected
- Unable to give informed consent
About this study
Official title: Packing of Perianal Abscess Cavities (PPAC) Trial: A Randomised Multicentre Trial Comparing Packing With Non-packing of the Abscess Cavity
The aim of this study is to compare the effect of packing and non-packing on the healing rate of perianal abscess cavities. Secondary objectives are to assess quality of life, cost effectiveness and rate of abscess recurrence and fistula-in-ano formation. If there is no difference in time to healing and non-packing is shown to be safe, acceptable to the patient and cost effective, this approach may become more widely accepted.
- Conditions
- Perianal Abscess
- Being tested
- Packing of abscess cavity, External dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Packing of abscess cavityOther
External dressingOther
Application of external dressing whilst abscess cavity heals
| Study group | Role | What they receive |
|---|---|---|
| Non-packing of abscess cavity | Experimental | Not described Receives: Other: External dressing |
| Packing of abscess cavity | Other | Current practice Receives: Other: Packing of abscess cavity; Other: External dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to wound healing in days, defined as complete epithelialisation of the abscess cavity.
time to healing will be assessed in days
Measured: 1 day to 6 weeks
Secondary outcomes (1)
Quality of life scores as determined by the Euro QoL EQ-5D-3L
Quality of life scores as determined by the Euro QoL EQ-5D-3L will be measured at 10-14 days following incision and drainage of abscess
Measured: 10 to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Primary completionJan 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Western Research Collaborative
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739478
- Sponsor's protocol ID
- NWRC-PPAC
- Acronym
- PPAC
- Status last verified
- Dec 2012
- First submitted
- 29 Nov 2012
- Last updated
- 4 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Packing of Perianal Abscess Cavities (PPAC) Trial: A Randomised Multicentre Trial Comparing Packing With Non-packing of the Abscess Cavity
- ClinicalTrials.gov ID
- NCT01739478
- Acronym / sponsor ID
- PPAC / NWRC-PPAC
- Conditions
- Perianal Abscess
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- North Western Research CollaborativeResearch network
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 3 Dec 2012 (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.
The aim of this study is to compare the effect of packing and non-packing on the healing rate of perianal abscess cavities. Secondary objectives are to assess quality of life, cost effectiveness and rate of abscess recurrence and fistula-in-ano formation. If there is no difference in time to healing and non-packing is shown to be safe, acceptable to the patient and cost effective, this approach may become more widely accepted.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-packing of abscess cavity | Experimental | Other: External dressing |
| Packing of abscess cavity | Other | Other: Packing of abscess cavity, Other: External dressingCurrent practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of acute primary perianal abscess
- Have undergone surgical incision and drainage as an emergency
Key exclusion criteria (3 listed)
- The abscess is the sequelae of concurrent disease or trauma
- Fourniers gangrene is suspected
- Unable to give 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 |
|---|---|---|
| Packing of abscess cavity | Other | Packing of abscess cavity |
| External dressingApplication of external dressing whilst abscess cavity heals | Other | Non-packing of abscess cavity, Packing of abscess cavity |
Primary outcome
Time to wound healing in days, defined as complete epithelialisation of the abscess cavity.
Time frame: 1 day to 6 weeks
time to healing will be assessed in days
1 secondary outcome
Quality of life scores as determined by the Euro QoL EQ-5D-3L
Time frame: 10 to 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Packing of abscess cavity and External dressing in people with Perianal Abscess, run by North Western Research Collaborative.
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 3 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 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Time to wound healing in days, defined as complete epithelialisation of the abscess cavity. (time frame: 1 day to 6 weeks). 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 4 Dec 2012.