- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00465049
Comparison of Suturing and Packing of Drained Abscesses
October 19, 2012 updated by: Adam Singer, Stony Brook University
Primary vs. Secondary Closure of Cutaneous Abscesses After I&D: A RCT
The standard treatment for skin abscesses in drainage followed by packing to prevent premature closure and reaccumulation of pus.
Studies from the 1950s and later conducted outside of the US suggest that when drained abscesses are drained and sutured closed they actually heal faster without complications.
The current study compares the time to healing and scar formation when drained abscesses are packed or sutured.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Stony Brook, New York, United States, 11794
- Stony Brook University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Non complicated abscesses
Exclusion Criteria:
- Fever,
- Immunocompromise,
- Cellulitis,
- Perianal and
- Pilonidal abscesses
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: primary closure
suture after I&D
|
SUTURE
|
Placebo Comparator: SECONDARY CLOSURE
LEAVE TO HEAL BY SECONDARY INTENTIN AFTER I&D
|
ALLOW TO HEAL SPONTANEOUSLY
SECONDARY HEALING AFTER I&D
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Days to healing.
Time Frame: 1 week
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Need for subsequent drainage, scar appearance.
Time Frame: 1 week
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adam J Singer, MD, Stony Brook University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- ELLIS M. Incision and primary suture of abscesses of the anal region. Proc R Soc Med. 1960 Aug;53(8):652-3. No abstract available.
- Khanna YK, Khanna A, Singh SP, Laddha BL, Prasad P, Jhanji RN. Primary closure of gluteal injection abscess (a study of 100 cases). J Postgrad Med. 1984 Apr;30(2):105-10. No abstract available.
- Ajao OG, Ladipo JK, al-Saigh AA, Malatani T. Primary closure of breast abscess compared with the conventional gauze packing and daily dressings. West Afr J Med. 1994 Jan-Mar;13(1):28-30.
- Stewart 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.
- Edino ST, Ihezue CH, Obekpa PO. Outcome of primary closure of incised acute soft-tissue abscesses. Niger Postgrad Med J. 2001 Mar;8(1):32-6.
- Abraham 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.
- Singer AJ, Taira BR, Chale S, Bhat R, Kennedy D, Schmitz G. Primary versus secondary closure of cutaneous abscesses in the emergency department: a randomized controlled trial. Acad Emerg Med. 2013 Jan;20(1):27-32. doi: 10.1111/acem.12053.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
April 23, 2007
First Submitted That Met QC Criteria
April 23, 2007
First Posted (Estimate)
April 24, 2007
Study Record Updates
Last Update Posted (Estimate)
October 22, 2012
Last Update Submitted That Met QC Criteria
October 19, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CORIHS 2007-5819
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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