Skin AbscessNCT02286479
Comparison of Loop and Primary Incision&Drainage Techniques in the Emergency Department
A study testing Incision and Drainage and Loop drainage in people with Skin Abscess, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Abscess
- What is being tested?
- Incision and Drainage and Loop drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients presenting to Kocaeli University Emergency Department with cutaneous abscess.
- Providing written informed consent.
Who cannot join
- Under 18 years of age.
- Immunosuppressive patients.
- Using medications have effects on wound healing.
- Abscess is not recognizable by bedside ultrasound.
- Lidocaine allergy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University Medical Faculty Emergency Medicine Department
Kocaeli, 41730
About this study
Official title: Comparison of Loop Drainage and Primary Incision and Drainage Techniques in Patients With Cutaneous Abscess in the Emergency Department
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.
- Conditions
- Skin Abscess
- Being tested
- Incision and Drainage, Loop drainage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incision and DrainageProcedure or surgery
In the incision and drainage group, the abscesses are incised, irrigated by sterile solutions and drained conventionally.
Loop drainageProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Incision and Drainage | Active comparator | In the incision and drainage group, the abscesses are incised, irrigated by sterile solutions and drained conventionally. Receives: Procedure: Incision and Drainage |
| Loop drainage | Experimental | 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. Receives: Procedure: Loop drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abscess Resolution
Measured: 7 days
Secondary outcomes (1)
Procedure Time
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Ulas Ozturan, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286479
- Sponsor's protocol ID
- KOU KAEK 2014/259
- Status last verified
- Aug 2016
- First submitted
- 5 Nov 2014
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 28162873
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Loop Drainage and Primary Incision and Drainage Techniques in Patients With Cutaneous Abscess in the Emergency Department
- ClinicalTrials.gov ID
- NCT02286479
- Acronym / sponsor ID
- KOU KAEK 2014/259
- Conditions
- Skin Abscess
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 7 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incision and Drainage | Active comparator | Procedure: Incision and DrainageIn the incision and drainage group, the abscesses are incised, irrigated by sterile solutions and drained conventionally. |
| Loop drainage | Experimental | Procedure: Loop drainageIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients presenting to Kocaeli University Emergency Department with cutaneous abscess.
- Providing written informed consent.
Key exclusion criteria (5 listed)
- Under 18 years of age.
- Immunosuppressive patients.
- Using medications have effects on wound healing.
- Abscess is not recognizable by bedside ultrasound.
- Lidocaine allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incision and DrainageIn the incision and drainage group, the abscesses are incised, irrigated by sterile solutions and drained conventionally. | Procedure or surgery | Incision and Drainage |
| Loop drainageIn 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. | Procedure or surgery | Loop drainage |
Primary outcome
Abscess Resolution
Time frame: 7 days
1 secondary outcome
Procedure Time
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
- Derived from this study: PubMed 28162873Ozturan 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incision and Drainage and Loop drainage in people with Skin Abscess, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abscess Resolution (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02286479, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2016.