AbscessPhase 4NCT00746109
Study of Wound Packing After Superficial Skin Abscess Drainage
A Phase 4 study testing Wound packing and NoPacking in people with Abscess and Skin Diseases, Infectious, run by NYU Langone Health at 1 site in United States.
Trial summary
Superficial skin and soft tissue abscess are frequently managed by opening them up with a procedure called "incision and drainage". It is routine practice in the United States to place packing material inside the abscess cavity after opening them up, in order to promote better wound healing and limit abscess… Read more about this study
- Who is it for?
- Ages 1 year to 24 years
- Conditions the study is for
- Abscess, Skin Diseases, Infectious, Boils
- What is being tested?
- Wound packing and NoPacking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Mar 2010
- Phase
- Phase 4
- 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 1 year to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 1 - 24 years (i.e. any child seen in PED)
- Suspected abscess deemed to need incision \& drainage by attending physician or fellow
- Size of abscess is greater than or equal to 1cm
- Parent or patient consent, and child assent
Who cannot join
- Location of abscess on face, perianal, or genitals
- History of recurrent or chronic abscess
- Multiple abscesses requiring drainage at current visit
- Immunocompromised or unstable patient
- HIV, transplant recipient, immune deficiency syndrome
- immunosuppressive medications
Show all 9Show fewer
- Wound already open/draining
- Previous participation in trial
- Patient will not be following up / managed by PES (e.g. surgical site)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University / Bellevue Hospital Center
New York, New York, 10016
About this study
Official title: Randomized Clinical Trial of Wound Packing Following Incision and Drainage of Superficial Skin Abscesses in the Pediatric Emergency Department
Superficial skin and soft tissue abscess are frequently managed by opening them up with a procedure called "incision and drainage". It is routine practice in the United States to place packing material inside the abscess cavity after opening them up, in order to promote better wound healing and limit abscess recurrence. However, this practice has never been systematically studied or proven to decrease complications or improve healing. Patients with wound packing usually return to the emergency room or practice setting for multiple "wound checks" and dressing/packing changes which lead to missed days from work or school and utilization of healthcare resources. This procedure can often be painful and may even require conscious sedation (and the risks entailed) especially in children. With rates of superficial skin and soft tissue abscesses on the rise, and emergency room resources being stretched, it is important to determine whether packing wounds is necessary or even advantageous to patients.
This study is the first to systematically evaluate the efficacy of wound packing after superficial skin or soft tissue abscess incision and drainage in children. The investigators will be evaluating wound healing, complications, recurrence and pain associated with packing both short and long term. In addition, the investigators will also be evaluating the utility of bedside point-of-care ultrasound use in predicting the presence of pus inside the abscess cavity. This test may be useful to determine whether incision and drainage is necessary for an individual who has a skin infection that is suspicious for an abscess.
- Conditions
- Abscess, Skin Diseases, Infectious, Boils, Furuncle, Carbuncle, Folliculitis
- Being tested
- Wound packing, NoPacking
- Keywords
- randomized, clinical trial, ultrasound, prospective, abscess, packing, incision and drainage, superficial soft tissue infection
- Medical subject headings
- Abscess, Skin Diseases, Infectious, Furunculosis, Carbuncle, Folliculitis, Cellulitis, Wounds and Injuries, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound packingProcedure or surgery
1/4" non-iodoform packing loosely placed inside abscess cavity.
NoPackingProcedure or surgery
This is a routine incision and drainage procedure but without the use of packing. Sterile gauze dressing will be placed over the abscess cavity.
| Study group | Role | What they receive |
|---|---|---|
| NOPACKING | Placebo comparator | The comparison group will undergo a routine incision and drainage procedure but will not have packing placed inside the abscess cavity. Receives: Procedure: NoPacking |
| PACKING | Experimental | This group will receive wound packing as per usual protocol Receives: Procedure: Wound packing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing (resolution, cosmesis, complications and recurrence)
Measured: one month
Ultrasound test characteristics
Measured: day one
Secondary outcomes (2)
Parental/patient satisfaction
Measured: one month
Cost-effectiveness
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2010
- Study completionMar 2010
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 AbscessStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746109
- Sponsor's protocol ID
- 08-143
- Status last verified
- Jan 2011
- First submitted
- 2 Sep 2008
- Last updated
- 4 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kessler DO, Krantz A, Mojica M. Randomized trial comparing wound packing to no wound packing following incision and drainage of superficial skin abscesses in the pediatric emergency department. Pediatr Emerg Care. 2012 Jun;28(6):514-7. doi: 10.1097/PEC.0b013e3182587b20.
PubMed 22653459
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Wound Packing Following Incision and Drainage of Superficial Skin Abscesses in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT00746109
- Acronym / sponsor ID
- 08-143
- Conditions
- Abscess, Skin Diseases, Infectious, Boils, Furuncle, Carbuncle, Folliculitis
- Keywords
- randomized, clinical trial, ultrasound, prospective, abscess, packing, incision and drainage, superficial soft tissue infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 3 Sep 2008 (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.
Superficial skin and soft tissue abscess are frequently managed by opening them up with a procedure called "incision and drainage". It is routine practice in the United States to place packing material inside the abscess cavity after opening them up, in order to promote better wound healing and limit abscess recurrence. However, this practice has never been systematically studied or proven to decrease complications or improve healing. Patients with wound packing usually return to the emergency room or practice setting for multiple "wound checks" and dressing/packing changes which lead to missed days from work or school and utilization of healthcare resources. This procedure can often be painful and may even require conscious sedation (and the risks entailed) especially in children. With rates of superficial skin and soft tissue abscesses on the rise, and emergency room resources being stretched, it is important to determine whether packing wounds is necessary or even advantageous to patients.
This study is the first to systematically evaluate the efficacy of wound packing after superficial skin or soft tissue abscess incision and drainage in children. The investigators will be evaluating wound healing, complications, recurrence and pain associated with packing both short and long term. In addition, the investigators will also be evaluating the utility of bedside point-of-care ultrasound use in predicting the presence of pus inside the abscess cavity. This test may be useful to determine whether incision and drainage is necessary for an individual who has a skin infection that is suspicious for an abscess.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOPACKING | Placebo comparator | Procedure: NoPackingThe comparison group will undergo a routine incision and drainage procedure but will not have packing placed inside the abscess cavity. |
| PACKING | Experimental | Procedure: Wound packingThis group will receive wound packing as per usual protocol |
Who may qualify
- Ages
- 1 year to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 1 - 24 years (i.e. any child seen in PED)
- Suspected abscess deemed to need incision \& drainage by attending physician or fellow
- Size of abscess is greater than or equal to 1cm
- Parent or patient consent, and child assent
Key exclusion criteria (9 listed)
- Location of abscess on face, perianal, or genitals
- History of recurrent or chronic abscess
- Multiple abscesses requiring drainage at current visit
- Immunocompromised or unstable patient
- HIV, transplant recipient, immune deficiency syndrome
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 |
|---|---|---|
| Wound packing1/4" non-iodoform packing loosely placed inside abscess cavity. | Procedure or surgery | PACKING |
| NoPackingThis is a routine incision and drainage procedure but without the use of packing. Sterile gauze dressing will be placed over the abscess cavity. | Procedure or surgery | NOPACKING |
Primary outcome
Healing (resolution, cosmesis, complications and recurrence)
Time frame: one month
Ultrasound test characteristics
Time frame: day one
2 secondary outcomes
Parental/patient satisfaction
Time frame: one month
Cost-effectiveness
Time frame: one month
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 4 Jan 2011.
- Derived from this study: PubMed 22653459Kessler DO, Krantz A, Mojica M. Randomized trial comparing wound packing to no wound packing following incision and drainage of superficial skin abscesses in the pediatric emergency department. Pediatr Emerg Care. 2012 Jun;28(6):514-7. doi: 10.1097/PEC.0b013e3182587b20.
Related trials for Abscess
Not yet recruitingPhase 2
Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses
Abscess
RecruitingPhase 4
A Single Dose of Intravenous Penicillin as an Adjunct to Oral Penicillin in the Treatment of Acute Tonsillitis, Peritonsillar Phlegmon, and Peritonsillar Abscess
Acute Tonsillitis, Peritonsillar Abscess
RecruitingPhase 1
A Study of Amicidin-β Topical Solution for Patients With a Contaminated or Infected Surgical or Traumatic Wound or Cutaneous Abscess
Surgical Wound Infection, Traumatic Wound Infection
Active, not recruitingObservational study
A Retrospective Cohort Study on the Non-Surgical Treatment of Periapical Inflammatory Lesions With Vitapex Paste
Periapical Periodontitis, Periapical Abscess
RecruitingPhase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
Metastatic Breast Cancer, Leptomeningeal Disease
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 Phase 4 study testing Wound packing and NoPacking in people with Abscess and Skin Diseases, Infectious, run by NYU Langone Health 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 4 inclusion and 9 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 4 Jan 2011. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Healing (resolution, cosmesis, complications and recurrence) (time frame: one month). The study lists 2 primary outcomes in all. 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 NCT00746109, 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 4 Jan 2011.