Cutanoeus AbscessesPhase 2NCT00465049
Comparison of Suturing and Packing of Drained Abscesses
A Phase 2 study testing PRIMARY CLOSRE, SECONDARY CLOSURE and SPONTANEOUS HALING in people with Cutanoeus Abscesses, run by Stony Brook University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cutanoeus Abscesses
- What is being tested?
- PRIMARY CLOSRE, SECONDARY CLOSURE and SPONTANEOUS HALING
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Feb 2012
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non complicated abscesses
Who cannot join
- Fever,
- Immunocompromise,
- Cellulitis,
- Perianal and
- Pilonidal abscesses
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University Hospital
Stony Brook, New York, 11794
About this study
Official title: 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.
- Conditions
- Cutanoeus Abscesses
- Being tested
- PRIMARY CLOSRE, SECONDARY CLOSURE, SPONTANEOUS HALING
- Keywords
- abscess, primary closure, secondary closure
- Medical subject headings
- Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIMARY CLOSREOther
SUTURE
SECONDARY CLOSUREOther
ALLOW TO HEAL SPONTANEOUSLY
SPONTANEOUS HALINGOther
SECONDARY HEALING AFTER I\&D
| Study group | Role | What they receive |
|---|---|---|
| primary closure | Experimental | suture after I\&D Receives: Other: PRIMARY CLOSRE |
| SECONDARY CLOSURE | Placebo comparator | LEAVE TO HEAL BY SECONDARY INTENTIN AFTER I\&D Receives: Other: SECONDARY CLOSURE; Other: SPONTANEOUS HALING |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days to healing.
Measured: 1 week
Secondary outcomes (1)
Need for subsequent drainage, scar appearance.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2007 (estimated)
- Study startJan 2007
- Primary completionJan 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cutanoeus AbscessesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Singer, Stony Brook University
- Investigators
- Adam J Singer, MD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465049
- Sponsor's protocol ID
- CORIHS 2007-5819
- Status last verified
- Oct 2012
- First submitted
- 23 Apr 2007
- Last updated
- 22 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
ELLIS M. Incision and primary suture of abscesses of the anal region. Proc R Soc Med. 1960 Aug;53(8):652-3. doi: 10.1177/003591576005300819. No abstract available.
PubMed 13726484Khanna 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.
PubMed 6527292Ajao 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.
PubMed 8080827Stewart 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 3881155Edino 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.
PubMed 11487781Abraham 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 9137156Singer 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.
PubMed 23570475
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary vs. Secondary Closure of Cutaneous Abscesses After I&D: A RCT
- ClinicalTrials.gov ID
- NCT00465049
- Acronym / sponsor ID
- CORIHS 2007-5819
- Conditions
- Cutanoeus Abscesses
- Keywords
- abscess, primary closure, secondary closure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 24 Apr 2007 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary closure | Experimental | Other: PRIMARY CLOSREsuture after I\&D |
| SECONDARY CLOSURE | Placebo comparator | Other: SECONDARY CLOSURE, Other: SPONTANEOUS HALINGLEAVE TO HEAL BY SECONDARY INTENTIN AFTER I\&D |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non complicated abscesses
Key exclusion criteria (5 listed)
- Fever,
- Immunocompromise,
- Cellulitis,
- Perianal and
- Pilonidal abscesses
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 |
|---|---|---|
| PRIMARY CLOSRESUTURE | Other | primary closure |
| SECONDARY CLOSUREALLOW TO HEAL SPONTANEOUSLY | Other | SECONDARY CLOSURE |
| SPONTANEOUS HALINGSECONDARY HEALING AFTER I\&D | Other | SECONDARY CLOSURE |
Primary outcome
Days to healing.
Time frame: 1 week
1 secondary outcome
Need for subsequent drainage, scar appearance.
Time frame: 1 week
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 22 Oct 2012.
- Background: PubMed 13726484ELLIS M. Incision and primary suture of abscesses of the anal region. Proc R Soc Med. 1960 Aug;53(8):652-3. doi: 10.1177/003591576005300819. No abstract available.
- Background: PubMed 6527292Khanna 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.
- Background: PubMed 8080827Ajao 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.
- 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.
- Background: PubMed 11487781Edino 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.
- 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.
- Derived from this study: PubMed 23570475Singer 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.
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.
Adam J Singer, MD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRIMARY CLOSRE, SECONDARY CLOSURE and SPONTANEOUS HALING in people with Cutanoeus Abscesses, run by Stony Brook University 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 1 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 22 Oct 2012. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Days to healing. (time frame: 1 week). 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 NCT00465049, which also lists 7 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 22 Oct 2012.