Perianal AbscessNCT04832529
A Perianal Abscess Cavity Packing vs no Packing.
A study testing No packing of perianal abscess cavity in people with Perianal Abscess and Ischiorectal Abscess, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
This prospective randomized trial will be conducted in all patients undergoing packing or no packing for perianal abscess cavity after incision and drainage, for 6 months after approval from IRB in Surgical unit III, Civil Hospital Karachi. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Perianal Abscess, Ischiorectal Abscess
- What is being tested?
- No packing of perianal abscess cavity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2020to 31 Jul 2021
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- Age less than 70 years
- Perianal abscess
Who cannot join
- Suspected inflammatory bowel disease
- Fournier's gangrene
- Horseshoe/bilateral abscess
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Perianal Abscess Cavity Packing Versus no Packing; a Randomized Control Trial.
This prospective randomized trial will be conducted in all patients undergoing packing or no packing for perianal abscess cavity after incision and drainage, for 6 months after approval from IRB in Surgical unit III, Civil Hospital Karachi. Patient will be selected simple random sampling technique based on inclusion criteria. Patient will be assessed for post-operative pain, healing of cavity and recurrence of abscess. At first time of debridement pus or tissue will be sent for culture and sensitivity, meanwhile broad-spectrum antibiotic will be started.
Questionnaire will be filled by PI for post-operative pain, recurrence of abscess, quality of life, wound healing, post operative fistula in ano and chronic post surgical pain either due to packing or no packing.
Read the detailed description
This is an experimental randomized control trial will start 6 months after approval from Institution Review Board. All patients with perianal abscess after incision and drainage cavity will be either packed or not after informed consent. Pack will be changed daily as regular dressing till healing occurs. Packing reduces bleeding and heals cavity by effect of dressing solution in which gauze is soaked. Other group with dressing will be changed daily and will be assessed for healing week. There is no pain in simple dressing applied over cavity. Patient will receive broad spectrum antibiotics according to pus or tissue culture. During this period, laboratory investigation CBC, CRP will be sent to check the response. Sits bath will be advised to both groups. Post-operative pain, cavity healing will be assessed by faculty.
- Conditions
- Perianal Abscess, Ischiorectal Abscess
- Being tested
- No packing of perianal abscess cavity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No packing of perianal abscess cavityProcedure or surgery
introducing new method to no packing of abscess cavity.
| Study group | Role | What they receive |
|---|---|---|
| Perianal abscess cavity packing | Active comparator | Not described Receives: Procedure: No packing of perianal abscess cavity |
| Perianal abscess cavity no packing | Experimental | Not described Receives: Procedure: No packing of perianal abscess cavity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Pain will be assessed via visual analogue scale from 1-10 while changing of dressing.
Measured: 14 days
Secondary outcomes (1)
Decreases hospital visit
Hospital visits will be decreased when dressing only dressing to be done, not wound packing.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Mar 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental Randomized Control Trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lajpat Rai, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832529
- Sponsor's protocol ID
- IRB-1537/DUHS/Approval/2020
- Status last verified
- Aug 2022
- First submitted
- 21 Mar 2021
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Perianal Abscess Cavity Packing Versus no Packing; a Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT04832529
- Acronym / sponsor ID
- IRB-1537/DUHS/Approval/2020
- Conditions
- Perianal Abscess, Ischiorectal Abscess
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 5 Apr 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.
This prospective randomized trial will be conducted in all patients undergoing packing or no packing for perianal abscess cavity after incision and drainage, for 6 months after approval from IRB in Surgical unit III, Civil Hospital Karachi. Patient will be selected simple random sampling technique based on inclusion criteria. Patient will be assessed for post-operative pain, healing of cavity and recurrence of abscess. At first time of debridement pus or tissue will be sent for culture and sensitivity, meanwhile broad-spectrum antibiotic will be started.
Questionnaire will be filled by PI for post-operative pain, recurrence of abscess, quality of life, wound healing, post operative fistula in ano and chronic post surgical pain either due to packing or no packing.
Detailed description
This is an experimental randomized control trial will start 6 months after approval from Institution Review Board. All patients with perianal abscess after incision and drainage cavity will be either packed or not after informed consent. Pack will be changed daily as regular dressing till healing occurs. Packing reduces bleeding and heals cavity by effect of dressing solution in which gauze is soaked. Other group with dressing will be changed daily and will be assessed for healing week. There is no pain in simple dressing applied over cavity. Patient will receive broad spectrum antibiotics according to pus or tissue culture. During this period, laboratory investigation CBC, CRP will be sent to check the response. Sits bath will be advised to both groups. Post-operative pain, cavity healing will be assessed by faculty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Experimental Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Perianal abscess cavity packing | Active comparator | Procedure: No packing of perianal abscess cavity |
| Perianal abscess cavity no packing | Experimental | Procedure: No packing of perianal abscess cavity |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than 18 years
- Age less than 70 years
- Perianal abscess
Key exclusion criteria (3 listed)
- Suspected inflammatory bowel disease
- Fournier's gangrene
- Horseshoe/bilateral abscess
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 |
|---|---|---|
| No packing of perianal abscess cavityintroducing new method to no packing of abscess cavity. | Procedure or surgery | Perianal abscess cavity no packing, Perianal abscess cavity packing |
Primary outcome
Post-operative pain
Time frame: 14 days
Pain will be assessed via visual analogue scale from 1-10 while changing of dressing.
1 secondary outcome
Decreases hospital visit
Time frame: 3 weeks
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 26 Aug 2022.
- Individual participant dataSharing planned: No
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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?
A study testing No packing of perianal abscess cavity in people with Perianal Abscess and Ischiorectal Abscess, run by Dow University of Health Sciences at 1 site in Pakistan.
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 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: finished, as of the sponsor's last update on 26 Aug 2022. 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 Pakistan. 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?
Post-operative pain (time frame: 14 days). 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 26 Aug 2022.