Packing Versus no Packing in Perianal Abscess

December 9, 2025 updated by: King Edward Medical University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • King Edward Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Packing group
This group will undergo packing of perianal abccess after the drainage.
Procedure: Packing of perianal abccess with surgical gauze
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.
Procedure: Non-packing of perianal abccess
The patients in non-packing group received no packing of wound after drainage of parianal abccess.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King Edward Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dr. Hafsa Khan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Study Data/Documents

  1. 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

No

Studies a U.S. FDA-regulated device product

No

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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