Perianal AbccessNCT07280962
Packing Versus no Packing in Perianal Abscess
A study testing Packing of perianal abccess with surgical gauze and Non-packing of perianal abccess in people with Perianal Abccess, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
Perianal abscess is a common surgical emergency that causes significant pain and discomfort. The standard treatment involves incision and drainage (I\&D) of the abscess cavity, traditionally followed by packing to prevent re-accumulation of pus and to promote healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perianal Abccess
- What is being tested?
- Packing of perianal abccess with surgical gauze and Non-packing of perianal abccess
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2025to 30 Oct 2025
- 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
- Patients presenting in the emergency department diagnosed with acute perianal abscess (Diagnosed on the basis of history and clinical examination with ultrasonographic evidence of quantifiable collection and confirmed by needle aspiration of pus from swelling) based on history and examination, requiring incision and drainage.
Who cannot join
- Patients with prior perianal fistulas based on history and examination
- Patients with recurrent abscess (based on history)
- Horseshoe abscess as based on examination
- Previous pelvic irradiation (based on history)
- Immunocompromised patients
- Malignant abscess
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Outcomes Between Packing Versus no Packing in Perianal Abscess Cavity After Incision and Drainage
Perianal abscess is a common surgical emergency that causes significant pain and discomfort. The standard treatment involves incision and drainage (I\&D) of the abscess cavity, traditionally followed by packing to prevent re-accumulation of pus and to promote healing. However, packing is often painful, requires frequent dressing changes, and increases patient discomfort as well as healthcare costs. Recent studies suggest that leaving the cavity unpacked may result in similar healing outcomes while reducing postoperative pain and shortening the length of hospital stay. This randomized controlled trial aims to compare the outcomes of packing versus no packing of the perianal abscess cavity following I\&D. The study will evaluate postoperative pain using the Visual Analogue Scale at 6, 12, and 24 hours, duration of hospital stay, and the recurrence rate within one month. The findings of this research are expected to guide evidence-based clinical practice by improving patient comfort, reducing hospital burden, and optimizing postoperative care protocols.
Read the detailed description
This randomized controlled trial is designed to evaluate and compare the clinical outcomes of packing versus no packing of the perianal abscess cavity following incision and drainage (I\&D), the standard surgical management for this common anorectal condition. Perianal abscesses develop due to infection and obstruction of the anal glands, resulting in severe pain, swelling, and systemic discomfort. Traditionally, postoperative packing of the abscess cavity has been performed to maintain drainage, achieve hemostasis, and prevent re-accumulation of pus; however, this practice is associated with considerable pain, delayed wound healing, repeated dressing changes, and increased hospital visits. In contrast, leaving the cavity unpacked and allowing healing by secondary intention may minimize patient discomfort, reduce healthcare costs, and shorten recovery time without increasing the risk of recurrence.
This study will be conducted among adult patients diagnosed with perianal abscess requiring I\&D, who will be randomly assigned to two groups: Group A (packing) and Group B (no packing). Postoperative pain will be assessed using the Visual Analogue Scale (VAS) at 6, 12, and 24 hours after the procedure. The duration of hospital stay and recurrence of the abscess within one month will also be recorded. Data will be analyzed using SPSS software, applying independent t-tests and chi-square tests to determine statistical significance, with a p-value < 0.05 considered significant. The findings of this study are expected to provide evidence-based insights into whether non-packing offers comparable or superior outcomes to conventional packing, ultimately guiding surgical practice toward safer, more comfortable, and cost-effective patient care.
- Conditions
- Perianal Abccess
- Being tested
- Packing of perianal abccess with surgical gauze, Non-packing of perianal abccess
- Keywords
- Perianal abccess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Packing of perianal abccess with surgical gauzeProcedure or surgery
Patients will undergo packing of perianal abcess after incision and drainage
Non-packing of perianal abccessProcedure or surgery
The patients in non-packing group received no packing of wound after drainage of parianal abccess.
| Study group | Role | What they receive |
|---|---|---|
| Packing group | Active comparator | This group will undergo packing of perianal abccess after the drainage. Receives: Procedure: Packing of perianal abccess with surgical gauze |
| Non-packing group | Placebo comparator | This group received no packing after drainage of perianal abcess. Receives: Procedure: Non-packing of perianal abccess |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pain
Patients was assessed for the post-operative pain by using VAS. VAS is a tool used to assess the intensity of pain in patients. The scoring ranges from 0-10, where 0 is minimum or no pain and 10 is maximum pain.
Measured: 24 hours
Secondary outcomes (1)
Recurrence
Recurrence will be labeled in a patient at 1 month follow-up period after incision and drainage if the patient complains of pain and fever, induration, and tenderness at the operated site, labeled as a perianal abscess at the same site, requiring incision and drainage.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 May 2025
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perianal AbccessStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280962
- Sponsor's protocol ID
- Dr. Hafsa Khan
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Perera AP, Howell AM, Sodergren MH, Farne H, Darzi A, Purkayastha S, Paraskeva P. A pilot randomised controlled trial evaluating postoperative packing of the perianal abscess. Langenbecks Arch Surg. 2015 Feb;400(2):267-71. doi: 10.1007/s00423-014-1231-5. Epub 2014 Jul 23.
PubMed 25053508
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes Between Packing Versus no Packing in Perianal Abscess Cavity After Incision and Drainage
- ClinicalTrials.gov ID
- NCT07280962
- Acronym / sponsor ID
- Dr. Hafsa Khan
- Conditions
- Perianal Abccess
- Keywords
- Perianal abccess
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 15 Dec 2025 (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.
Perianal abscess is a common surgical emergency that causes significant pain and discomfort. The standard treatment involves incision and drainage (I\&D) of the abscess cavity, traditionally followed by packing to prevent re-accumulation of pus and to promote healing. However, packing is often painful, requires frequent dressing changes, and increases patient discomfort as well as healthcare costs. Recent studies suggest that leaving the cavity unpacked may result in similar healing outcomes while reducing postoperative pain and shortening the length of hospital stay. This randomized controlled trial aims to compare the outcomes of packing versus no packing of the perianal abscess cavity following I\&D. The study will evaluate postoperative pain using the Visual Analogue Scale at 6, 12, and 24 hours, duration of hospital stay, and the recurrence rate within one month. The findings of this research are expected to guide evidence-based clinical practice by improving patient comfort, reducing hospital burden, and optimizing postoperative care protocols.
Detailed description
This randomized controlled trial is designed to evaluate and compare the clinical outcomes of packing versus no packing of the perianal abscess cavity following incision and drainage (I\&D), the standard surgical management for this common anorectal condition. Perianal abscesses develop due to infection and obstruction of the anal glands, resulting in severe pain, swelling, and systemic discomfort. Traditionally, postoperative packing of the abscess cavity has been performed to maintain drainage, achieve hemostasis, and prevent re-accumulation of pus; however, this practice is associated with considerable pain, delayed wound healing, repeated dressing changes, and increased hospital visits. In contrast, leaving the cavity unpacked and allowing healing by secondary intention may minimize patient discomfort, reduce healthcare costs, and shorten recovery time without increasing the risk of recurrence.
This study will be conducted among adult patients diagnosed with perianal abscess requiring I\&D, who will be randomly assigned to two groups: Group A (packing) and Group B (no packing). Postoperative pain will be assessed using the Visual Analogue Scale (VAS) at 6, 12, and 24 hours after the procedure. The duration of hospital stay and recurrence of the abscess within one month will also be recorded. Data will be analyzed using SPSS software, applying independent t-tests and chi-square tests to determine statistical significance, with a p-value < 0.05 considered significant. The findings of this study are expected to provide evidence-based insights into whether non-packing offers comparable or superior outcomes to conventional packing, ultimately guiding surgical practice toward safer, more comfortable, and cost-effective patient care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Packing group | Active comparator | Procedure: Packing of perianal abccess with surgical gauzeThis group will undergo packing of perianal abccess after the drainage. |
| Non-packing group | Placebo comparator | Procedure: Non-packing of perianal abccessThis group received no packing after drainage of perianal abcess. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting in the emergency department diagnosed with acute perianal abscess (Diagnosed on the basis of history and clinical examination with ultrasonographic evidence of quantifiable collection and confirmed by needle aspiration of pus from swelling) based on history and examination, requiring incision and drainage.
Key exclusion criteria (6 listed)
- Patients with prior perianal fistulas based on history and examination
- Patients with recurrent abscess (based on history)
- Horseshoe abscess as based on examination
- Previous pelvic irradiation (based on history)
- Immunocompromised patients
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 perianal abccess with surgical gauzePatients will undergo packing of perianal abcess after incision and drainage | Procedure or surgery | Packing group |
| Non-packing of perianal abccessThe patients in non-packing group received no packing of wound after drainage of parianal abccess. | Procedure or surgery | Non-packing group |
Primary outcome
Post-operative Pain
Time frame: 24 hours
Patients was assessed for the post-operative pain by using VAS. VAS is a tool used to assess the intensity of pain in patients. The scoring ranges from 0-10, where 0 is minimum or no pain and 10 is maximum pain.
1 secondary outcome
Recurrence
Time frame: 1 month
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 15 Dec 2025.
- Background: PubMed 25053508Perera AP, Howell AM, Sodergren MH, Farne H, Darzi A, Purkayastha S, Paraskeva P. A pilot randomised controlled trial evaluating postoperative packing of the perianal abscess. Langenbecks Arch Surg. 2015 Feb;400(2):267-71. doi: 10.1007/s00423-014-1231-5. Epub 2014 Jul 23.
- This study elaborates the outcomes of role of packing in perianal abcess.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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 Packing of perianal abccess with surgical gauze and Non-packing of perianal abccess in people with Perianal Abccess, run by King Edward Medical University 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 1 inclusion and 6 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 15 Dec 2025. 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. Some participants in this study may receive a placebo. 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: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07280962, which also lists 1 linked publication.
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 15 Dec 2025.