CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 111 enrolled
Drug / intervention
Clindamycin +2 moredrug
Likely dose
Clindamycin 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02585141
NCT02585141N/ACompleted

Aspiration or Surgical Drainage of Perianal Abscess. A Randomized Controlled Clinical Study

University of Southern Denmark·interventional·Posted Oct 23, 2015·Updated Nov 13, 2020

In Brief

A clinical study evaluating MEDIPLAST® (aspiration), incision, and 1 other intervention for Anal Fistulas. Completed, enrolled 111 participants across 1 site.

Detailed Summary

The purpose of this study is to compare aspiration and oral antibiotics with surgical incision in the treatment of perianal abscesses in terms of recurrence and subsequent fistula formation. Included patients will be randomised to either aspiration or incision.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnal Fistulas
CountriesDenmark

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 23, 2015
Enrollment StartOct 1, 2015
Primary CompletionJun 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 10.7 years ago

Interventions

MEDIPLAST® (aspiration)device

The aspiration drainage will be with a large caliber needle (MEDIPLAST® 13 G, 2,5 x 110 mm) and a syringe of 20 ml. The cavity must be emptied for pus and irrigated by repeated injection and aspiration of saline until clear fluid is obtained.

incisionprocedure

Incision drainage will be undertaken as standardized de-roofing of the abscess and debridement. Wound packing and dressing will not be used, just sitz bath or ordinary hygiene until wound healing.

Clindamycindrug

Postoperative broad spectrum oral antibiotics covering both aerobes and anaerobes bacteria will be given for seven days of Clindamycin 300 mg tablets x 3 a day