Back to resultsComparison of Loop and Primary Incision&Drainage Techniques in the Emergency Department
Primary Purpose
Skin Abscess
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Incision and Drainage
Loop drainage
Sponsored by
About this trial
This is an interventional treatment trial for Skin Abscess
Eligibility Criteria
Inclusion Criteria:
- Adult patients presenting to Kocaeli University Emergency Department with cutaneous abscess.
- Providing written informed consent.
Exclusion Criteria:
- Under 18 years of age.
- Immunosuppressive patients.
- Using medications have effects on wound healing.
- Abscess is not recognizable by bedside ultrasound.
- Lidocaine allergy
Sites / Locations
- Kocaeli University Medical Faculty Emergency Medicine Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Incision and Drainage
Loop drainage
Arm Description
In the incision and drainage group, the abscesses are incised, irrigated by sterile solutions and drained conventionally.
In the loop drainage group, two small incision are made on each side of abscess. The pus are drained and septations are seperated by a forceps. Abscess cavitary irrigated by sterile solution. Sterile, non-powder, non-latex surgical gloves cuff is inserted in one incision and taken out from the other insicion. Then two tips of cuff are tied loosely.
Outcomes
Primary Outcome Measures
Abscess Resolution
Secondary Outcome Measures
Procedure Time
Full Information
NCT ID
NCT02286479
First Posted
November 5, 2014
Last Updated
August 12, 2016
Sponsor
Kirsehir Ahi Evran University
1. Study Identification
Unique Protocol Identification Number
NCT02286479
Brief Title
Comparison of Loop and Primary Incision&Drainage Techniques in the Emergency Department
Official Title
Comparison of Loop Drainage and Primary Incision and Drainage Techniques in Patients With Cutaneous Abscess in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Skin abscesses are among the most common soft tissue infections cause emergency room visits frequently. Management of abscess drainage and prevent further complications are important entities for emergency physicians. Historically primary incision and drainage (I&D) technique has found very effective method of abscess drainage, however a novel technique loop drainage holds promising. The purpose of our study is comparison efficacy of I&D and loop drainage techniques in patients with cutaneous abscess.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Abscess
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Incision and Drainage
Arm Type
Active Comparator
Arm Description
In the incision and drainage group, the abscesses are incised, irrigated by sterile solutions and drained conventionally.
Arm Title
Loop drainage
Arm Type
Experimental
Arm Description
In the loop drainage group, two small incision are made on each side of abscess. The pus are drained and septations are seperated by a forceps. Abscess cavitary irrigated by sterile solution. Sterile, non-powder, non-latex surgical gloves cuff is inserted in one incision and taken out from the other insicion. Then two tips of cuff are tied loosely.
Intervention Type
Procedure
Intervention Name(s)
Incision and Drainage
Intervention Description
In the incision and drainage group, the abscesses are incised, irrigated by sterile solutions and drained conventionally.
Intervention Type
Procedure
Intervention Name(s)
Loop drainage
Intervention Description
In the loop drainage group, two small incision are made on each side of abscess. The pus are drained and septations are seperated by a forceps. Abscess cavitary irrigated by sterile solution. Sterile, non-powder, non-latex surgical gloves cuff is inserted in one incision and taken out from the other insicion. Then two tips of cuff are tied loosely.
Primary Outcome Measure Information:
Title
Abscess Resolution
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Procedure Time
Time Frame
intraoperative
Other Pre-specified Outcome Measures:
Title
Procedure Pain Intensity
Time Frame
intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients presenting to Kocaeli University Emergency Department with cutaneous abscess.
Providing written informed consent.
Exclusion Criteria:
Under 18 years of age.
Immunosuppressive patients.
Using medications have effects on wound healing.
Abscess is not recognizable by bedside ultrasound.
Lidocaine allergy
Facility Information:
Facility Name
Kocaeli University Medical Faculty Emergency Medicine Department
City
Kocaeli
ZIP/Postal Code
41730
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
28162873
Citation
Ozturan IU, Dogan NO, Karakayali O, Ozbek AE, Yilmaz S, Pekdemir M, Suner S. Comparison of loop and primary incision & drainage techniques in adult patients with cutaneous abscess: A preliminary, randomized clinical trial. Am J Emerg Med. 2017 Jun;35(6):830-834. doi: 10.1016/j.ajem.2017.01.036. Epub 2017 Jan 22.
Results Reference
derived
Learn more about this trial
Comparison of Loop and Primary Incision&Drainage Techniques in the Emergency Department
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