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Completed

NCT Number: NCT04832529

A Perianal Abscess Cavity Packing vs no Packing.

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.

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Key information

Conditions

Perianal Abscess Ischiorectal Abscess

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Ruth K.M Pfau Civil Hospital

Karachi, Sindh, 75000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age greater than 18 years
  • Age less than 70 years
  • Perianal abscess

Exclusion criteria

  • Suspected inflammatory bowel disease
  • Fournier's gangrene
  • Horseshoe/bilateral abscess

Treatment and study plan

No packing of perianal abscess cavity

Procedure

introducing new method to no packing of abscess cavity.

Primary outcomes

  1. Post-operative pain

    Time frame: 14 days

    Pain will be assessed via visual analogue scale from 1-10 while changing of dressing.

Secondary outcomes

  1. Decreases hospital visit

    Time frame: 3 weeks

    Hospital visits will be decreased when dressing only dressing to be done, not wound packing.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

A Perianal Abscess Cavity Packing Versus no Packing; a Randomized Control Trial.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 5, 2021
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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