Cutaneous AbscessNCT01606657
Irrigation Versus no Irrigation for Cutaneous Abscess
A study testing Irrigation and No Irrigation in people with Cutaneous Abscess, run by University of California, San Francisco at 1 site in United States.
Trial summary
In this study, the investigators are trying to find out if washing out the abscess (pocket of pus) with fluid will help, instead of only taking out the pus. Your care will be the same as usual, except that you will be selected randomly to have your abscess washed out with fluid, or not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Abscess
- What is being tested?
- Irrigation and No Irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Apr 2015
- 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
- All patients 18 years of age and above
- Patients that require a cutaneous abscess incision and drainage
Who cannot join
- Unable to return for 48-hour followup.
- Patients being admitted to the hospital or going to the operating room for incision and drainage
- Pregnant patients
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Regional Trauma and Burn Center
Fresno, California, 93721
About this study
Official title: Is Routine Irrigation of Cutaneous Abscesses Necessary?
In this study, the investigators are trying to find out if washing out the abscess (pocket of pus) with fluid will help, instead of only taking out the pus. Your care will be the same as usual, except that you will be selected randomly to have your abscess washed out with fluid, or not.
Read the detailed description
Irrigation of the abscess cavity is commonly described as part of the procedure of incision and drainage of cutaneous abscesses (1-4). Despite this, there are no randomized controlled trials that demonstrate the benefit of irrigation in treatment of these abscesses. Potential disadvantages of irrigation include increased procedural time, pain, increased cost with sterile irrigation solutions and materials to capture the irrigation effluent, and increased risk of microbiologic contamination of the surrounding area. The goal of this study is to examine patients undergoing incision and drainage of cutaneous abscesses to determine if irrigation of the abscess cavity affects the need for further interventions.
- Conditions
- Cutaneous Abscess
- Being tested
- Irrigation, No Irrigation
- Keywords
- I&D, Abscess, Irrigation, Cutaneous Abscess
- Medical subject headings
- Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrrigationProcedure or surgery
The patient will receive irrigation as a part of their wound care
No IrrigationOther
The patient will not receive irrigation as part of their wound care
| Study group | Role | What they receive |
|---|---|---|
| Irrigation | Active comparator | THE PATIENT IS TO HAVE IRRIGATION OF THE ABSCESS WITH NORMAL SALINE AS PART OF THE I\&D PROCEDURE Receives: Procedure: Irrigation |
| No Irrigation | Placebo comparator | THE PATIENT IS NOT TO HAVE IRRIGATION OF THE ABSCESS AS PART OF THE I\&D PROCEDURE Receives: Other: No Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients needing further treatment after irrigation for I&D
Percentage of patients needing further treatment i. Further treatment defined as
- Repeat I\&D
- Addition of an antibiotic (as new or to a pre-existing antibiotic)
- Admission to hospital for cutaneous abscess-related problem
- Abscess
- Cellulitis
- Septic arthritis
- Sepsis
Measured: 7 day phone follow-up
Secondary outcomes (1)
VAS is correlated with decreased pain after I&D
- VAS post procedure pain score
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2012 (estimated)
- Study startAug 2010
- Primary completionSep 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cutaneous AbscessStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Chinnock, University of California, San Francisco
- Investigators
- Brian Chinnock, MD, Principal investigator, UCSF, Community Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606657
- Sponsor's protocol ID
- 10012010
- Status last verified
- May 2017
- First submitted
- 21 May 2012
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
O'Malley GF, Dominici P, Giraldo P, Aguilera E, Verma M, Lares C, Burger P, Williams E. Routine packing of simple cutaneous abscesses is painful and probably unnecessary. Acad Emerg Med. 2009 May;16(5):470-3. doi: 10.1111/j.1553-2712.2009.00409.x. Epub 2009 Apr 10.
PubMed 19388915Abraham N, Doudle M, Carson P. Open versus closed surgical treatment of abscesses: a controlled clinical trial. Aust N Z J Surg. 1997 Apr;67(4):173-6. doi: 10.1111/j.1445-2197.1997.tb01934.x.
PubMed 9137156Llera JL, Levy RC. Treatment of cutaneous abscess: a double-blind clinical study. Ann Emerg Med. 1985 Jan;14(1):15-9. doi: 10.1016/s0196-0644(85)80727-7.
PubMed 3880635Stewart MP, Laing MR, Krukowski ZH. Treatment of acute abscesses by incision, curettage and primary suture without antibiotics: a controlled clinical trial. Br J Surg. 1985 Jan;72(1):66-7. doi: 10.1002/bjs.1800720125.
PubMed 3881155
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Routine Irrigation of Cutaneous Abscesses Necessary?
- ClinicalTrials.gov ID
- NCT01606657
- Acronym / sponsor ID
- 10012010
- Conditions
- Cutaneous Abscess
- Keywords
- I&D, Abscess, Irrigation, Cutaneous Abscess
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 May 2012 (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.
In this study, the investigators are trying to find out if washing out the abscess (pocket of pus) with fluid will help, instead of only taking out the pus. Your care will be the same as usual, except that you will be selected randomly to have your abscess washed out with fluid, or not.
Detailed description
Irrigation of the abscess cavity is commonly described as part of the procedure of incision and drainage of cutaneous abscesses (1-4). Despite this, there are no randomized controlled trials that demonstrate the benefit of irrigation in treatment of these abscesses. Potential disadvantages of irrigation include increased procedural time, pain, increased cost with sterile irrigation solutions and materials to capture the irrigation effluent, and increased risk of microbiologic contamination of the surrounding area. The goal of this study is to examine patients undergoing incision and drainage of cutaneous abscesses to determine if irrigation of the abscess cavity affects the need for further interventions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irrigation | Active comparator | Procedure: IrrigationTHE PATIENT IS TO HAVE IRRIGATION OF THE ABSCESS WITH NORMAL SALINE AS PART OF THE I\&D PROCEDURE |
| No Irrigation | Placebo comparator | Other: No IrrigationTHE PATIENT IS NOT TO HAVE IRRIGATION OF THE ABSCESS AS PART OF THE I\&D PROCEDURE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients 18 years of age and above
- Patients that require a cutaneous abscess incision and drainage
Key exclusion criteria (4 listed)
- Unable to return for 48-hour followup.
- Patients being admitted to the hospital or going to the operating room for incision and drainage
- Pregnant patients
- Prisoners
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 |
|---|---|---|
| IrrigationThe patient will receive irrigation as a part of their wound care | Procedure or surgery | Irrigation |
| No IrrigationThe patient will not receive irrigation as part of their wound care | Other | No Irrigation |
Primary outcome
Patients needing further treatment after irrigation for I&D
Time frame: 7 day phone follow-up
Percentage of patients needing further treatment i. Further treatment defined as 1. Repeat I\&D 2. Addition of an antibiotic (as new or to a pre-existing antibiotic) 3. Admission to hospital for cutaneous abscess-related problem 1. Abscess 2. Cellulitis 3. Septic arthritis 4. Sepsis
1 secondary outcome
VAS is correlated with decreased pain after I&D
Time frame: two years
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 3 May 2017.
- Background: PubMed 19388915O'Malley GF, Dominici P, Giraldo P, Aguilera E, Verma M, Lares C, Burger P, Williams E. Routine packing of simple cutaneous abscesses is painful and probably unnecessary. Acad Emerg Med. 2009 May;16(5):470-3. doi: 10.1111/j.1553-2712.2009.00409.x. Epub 2009 Apr 10.
- Background: PubMed 9137156Abraham N, Doudle M, Carson P. Open versus closed surgical treatment of abscesses: a controlled clinical trial. Aust N Z J Surg. 1997 Apr;67(4):173-6. doi: 10.1111/j.1445-2197.1997.tb01934.x.
- Background: PubMed 3880635Llera JL, Levy RC. Treatment of cutaneous abscess: a double-blind clinical study. Ann Emerg Med. 1985 Jan;14(1):15-9. doi: 10.1016/s0196-0644(85)80727-7.
- Background: PubMed 3881155Stewart MP, Laing MR, Krukowski ZH. Treatment of acute abscesses by incision, curettage and primary suture without antibiotics: a controlled clinical trial. Br J Surg. 1985 Jan;72(1):66-7. doi: 10.1002/bjs.1800720125.
- Individual participant dataSharing planned: No
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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.
Brian Chinnock, MD principal investigator
UCSF, Community Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrigation and No Irrigation in people with Cutaneous Abscess, run by University of California, San Francisco at 1 site in United States.
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 4 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 3 May 2017. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Patients needing further treatment after irrigation for I&D (time frame: 7 day phone follow-up). 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 NCT01606657, which also lists 4 linked publications.
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 3 May 2017.