- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07280962
Packing Versus no Packing in Perianal Abscess
Comparison of Outcomes Between Packing Versus no Packing in Perianal Abscess Cavity After Incision and Drainage
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- King Edward Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Packing group
This group will undergo packing of perianal abccess after the drainage.
|
Patients will undergo packing of perianal abcess after incision and drainage
|
|
Placebo Comparator: Non-packing group
This group received no packing after drainage of perianal abcess.
|
The patients in non-packing group received no packing of wound after drainage of parianal abccess.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recurrence
Time Frame: 1 month
|
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.
|
1 month
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Dr. Hafsa Khan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
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Study Protocol
Information comments: https://heyzine.com/flip-book/0d5ec370d6.html
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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