Cutaneous AbscessNCT02545946
Trial of Abscess Drainage Techniques
A study testing vessel loop and traditional I&D with or without packing in people with Cutaneous Abscess, run by Wake Forest University Health Sciences.
Trial summary
Comparing the outcome of traditional incision and drainage with a larger skin incision with or without gauze packing of cutaneous abscess in pediatrics versus a new minimally invasive incision and drainage with two small incisions and a vessel loop transversing the incisions to keep them open. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Abscess
- What is being tested?
- vessel loop and traditional I&D with or without packing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to 7 Jul 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pediatric patient (0-18 years old) with abscess over 3 cm which can be drained in the ER and does not require hospitalization
Who cannot join
- Diabetes
- immunocompromised
- cancer
- chemotherapy
- requires hospitalization for treatment of abscess
- abscess felt not drainable in the ER by ER physicians
About this study
Official title: Traditional Incision and Drainage of Cutaneous Abscess Vs. Minimally Invasive Incision and Drainage With Vessel Loop: A Randomized Control Trial.
Comparing the outcome of traditional incision and drainage with a larger skin incision with or without gauze packing of cutaneous abscess in pediatrics versus a new minimally invasive incision and drainage with two small incisions and a vessel loop transversing the incisions to keep them open.
Read the detailed description
This prospective randomized single blind clinical trial will be conducted in a suburban pediatric emergency department that treats approximately 29,000 patients per year. Patients between 0-17 years with a superficial skin or soft tissue abscess larger than 3 cm that would be appropriate for ED I\&D and outpatient management will be screened for inclusion. Patients will be excluded if they are immunocompromised (taking chemotherapy, steroid or bioactive medications or having diabetes mellitus), require a subspecialist for drainage or require hospitalization. Subjects will be required to provide assent when age-appropriate, and parental consent will be obtained. The parent or guardian will need to be in the emergency department with the child to provide consent. Subjects will be randomized to be in either the traditional I\&D arm or the minimally invasive vessel loop arm using numbered sealed envelops. Computer blocking will randomize these numbered envelopes. Inside the envelope there will be instructions to the treating physician as to which of two standard techniques should be employed.
- Standardized I\&D will be performed with a #11 blade scalpel and a full thickness cut incising the lesion along at least 50% of the abscess diameter. The pocket will then be probed to break up septations and the residual cavity will be irrigated with normal saline. Iodinated gauze 0.25 inch will be used to loosely pack the remaining cavity if the physician deems packing is necessary. The gauze will be left trailing out of the surgical incision. The abscess will then be covered with 4 X 4 dry gauze and taped in place.
- Minimally invasive I\&D with vessel loop will be preformed by making a 5mm incision with a #11 blade in the area of maximal fluctuance. The cavity will then be probed with forceps breaking up any septations. The forceps will then be used to find the furthest extent of the cavity, and the #11 blade will be used to make a 5mm incision at the tip of the forceps (at the farthest extent of the cavity). The forceps will then be pushed through this second incision. The vessel loop will be grasped by the forceps and then pulled back through both surgical incisions. The vessel loop will then be tied loosely together, creating a loop back through both surgical incisions. Both sides of the incisions will then be irrigated with normal saline.
Cultures will be obtained, if possible, from the abscess. Pain medication and sedation at the time of the I\&D will be left to the discretion of the treating physician. Antibiotics will not be mandated, but allowed at the judgment of the treating medical team. All subjects will be given 2 prescriptions for analgesia at home. One for mild pain, ibuprofen; another for moderate or severe pain, acetaminophen with hydrocodone (either liquid or pills) will be given. Equipotent alternatives will be provided in case of medication allergy. Pain scores will be assessed using a ten point scale before and after the procedure and at 48 hour follow up. Data recorded at the first visit will include demographics (age, male/female), characteristics of the abscess, fever, duration of symptoms, history of prior abscess, antibiotics in the last month, and provision of antibiotics post-procedure.
All subjects will return to the ER in 72 hours and 1 week for a recheck. At the 3rd day visit, wound packing will be removed. Large cavities will be repacked at the discretion of the ED physician. Loops will be cut and removed at the 7th day visit unless significant cellulitis remains. If cellulitis remains after 7 days, additional visits/hospitalization would be set up at the treating doctors discretion. Given that failure of treatment is a possible event in any abscess drainage, even those not involved with this study, hospitalization or additional visits beyond the 2 included in the study, will be billed to the patient's family and/or insurance company as any visit to the ER or hospital admission.
Patients and families will also be contacted at one month via telephone interview. Self-rated cosmetic outcome will be assessed using a 10 point scale from worst to best looking scar.
- Conditions
- Cutaneous Abscess
- Being tested
- vessel loop, traditional I&D with or without packing
- Keywords
- traditional incision and drainage, minimally invasive incision and drainage, vessel loop, emergency department, pediatrics
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vessel loopDevice
using the vessel loop to hold the place of the surgical wound that is made during I\&D
traditional I&D with or without packingOther
abscess will be drained with a traditional I\&D with or without packing (as deemed appropriate by ER doctor)
| Study group | Role | What they receive |
|---|---|---|
| Traditional | Active comparator | cutaneous abscess with be opened in the traditional incision and drainage technique with large incision, breaking up of pockets of pus, washing out the pocket and with or without packing gauze placed into residual cavity Receives: Other: traditional I&D with or without packing |
| Minimally Invasive | Active comparator | Cutaneous abscess will be opened with two small incisions just large enough to pass a vessel loop through both to keep them open. Pockets of pus will be broken up and the cavity washed out before placing the loop through both incisions and loosely tieing it over the skin Receives: Device: vessel loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients who require repeat I&D collected by data form
any patient that needs an additional I\&D procedure noted on data collection forms
Measured: 1 week
Number of patients who Need to have an antibiotic added to treatment plan/or changed antibiotic after the initial visit collected by data form
any patient requiring the above noted on data collection forms
Measured: 1 week
the number of patients who need to be hospitalized after the first visit collected by data form
if patient is hospitalized after first visit, as collected on data form
Measured: 1 week
Secondary outcomes (3)
patient satisfaction with procedure collected by survey
1-100 scale of satisfaction survey with the drainage performed
Measured: 1 day
patient satisfaction with healing of abscess collected by survey
1-100 scale survey of how satisfied patient is with how the drainage site healed
Measured: 1 month
patient satisfaction with overall treatment of the abscess collected by survey
1-100 scale survey for how satisfied patient is with overall care related to abscess
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startOct 2015
- Primary completion24 Jun 2016
- Study completion7 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous 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
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milan Nadkarni, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545946
- Sponsor's protocol ID
- IRB00033369
- Status last verified
- Feb 2019
- First submitted
- 29 Jul 2015
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Incision and Drainage of Cutaneous Abscess Vs. Minimally Invasive Incision and Drainage With Vessel Loop: A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT02545946
- Acronym / sponsor ID
- IRB00033369
- Conditions
- Cutaneous Abscess
- Keywords
- traditional incision and drainage, minimally invasive incision and drainage, vessel loop, emergency department, pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- 24 Jun 2016 (actual)
- Study completion
- 7 Jul 2016 (actual)
- First posted
- 10 Sep 2015 (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.
Comparing the outcome of traditional incision and drainage with a larger skin incision with or without gauze packing of cutaneous abscess in pediatrics versus a new minimally invasive incision and drainage with two small incisions and a vessel loop transversing the incisions to keep them open.
Detailed description
This prospective randomized single blind clinical trial will be conducted in a suburban pediatric emergency department that treats approximately 29,000 patients per year. Patients between 0-17 years with a superficial skin or soft tissue abscess larger than 3 cm that would be appropriate for ED I\&D and outpatient management will be screened for inclusion. Patients will be excluded if they are immunocompromised (taking chemotherapy, steroid or bioactive medications or having diabetes mellitus), require a subspecialist for drainage or require hospitalization. Subjects will be required to provide assent when age-appropriate, and parental consent will be obtained. The parent or guardian will need to be in the emergency department with the child to provide consent. Subjects will be randomized to be in either the traditional I\&D arm or the minimally invasive vessel loop arm using numbered sealed envelops. Computer blocking will randomize these numbered envelopes. Inside the envelope there will be instructions to the treating physician as to which of two standard techniques should be employed.
- Standardized I\&D will be performed with a #11 blade scalpel and a full thickness cut incising the lesion along at least 50% of the abscess diameter. The pocket will then be probed to break up septations and the residual cavity will be irrigated with normal saline. Iodinated gauze 0.25 inch will be used to loosely pack the remaining cavity if the physician deems packing is necessary. The gauze will be left trailing out of the surgical incision. The abscess will then be covered with 4 X 4 dry gauze and taped in place.
- Minimally invasive I\&D with vessel loop will be preformed by making a 5mm incision with a #11 blade in the area of maximal fluctuance. The cavity will then be probed with forceps breaking up any septations. The forceps will then be used to find the furthest extent of the cavity, and the #11 blade will be used to make a 5mm incision at the tip of the forceps (at the farthest extent of the cavity). The forceps will then be pushed through this second incision. The vessel loop will be grasped by the forceps and then pulled back through both surgical incisions. The vessel loop will then be tied loosely together, creating a loop back through both surgical incisions. Both sides of the incisions will then be irrigated with normal saline.
Cultures will be obtained, if possible, from the abscess. Pain medication and sedation at the time of the I\&D will be left to the discretion of the treating physician. Antibiotics will not be mandated, but allowed at the judgment of the treating medical team. All subjects will be given 2 prescriptions for analgesia at home. One for mild pain, ibuprofen; another for moderate or severe pain, acetaminophen with hydrocodone (either liquid or pills) will be given. Equipotent alternatives will be provided in case of medication allergy. Pain scores will be assessed using a ten point scale before and after the procedure and at 48 hour follow up. Data recorded at the first visit will include demographics (age, male/female), characteristics of the abscess, fever, duration of symptoms, history of prior abscess, antibiotics in the last month, and provision of antibiotics post-procedure.
All subjects will return to the ER in 72 hours and 1 week for a recheck. At the 3rd day visit, wound packing will be removed. Large cavities will be repacked at the discretion of the ED physician. Loops will be cut and removed at the 7th day visit unless significant cellulitis remains. If cellulitis remains after 7 days, additional visits/hospitalization would be set up at the treating doctors discretion. Given that failure of treatment is a possible event in any abscess drainage, even those not involved with this study, hospitalization or additional visits beyond the 2 included in the study, will be billed to the patient's family and/or insurance company as any visit to the ER or hospital admission.
Patients and families will also be contacted at one month via telephone interview. Self-rated cosmetic outcome will be assessed using a 10 point scale from worst to best looking scar.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional | Active comparator | Other: traditional I&D with or without packingcutaneous abscess with be opened in the traditional incision and drainage technique with large incision, breaking up of pockets of pus, washing out the pocket and with or without packing gauze placed into residual cavity |
| Minimally Invasive | Active comparator | Device: vessel loopCutaneous abscess will be opened with two small incisions just large enough to pass a vessel loop through both to keep them open. Pockets of pus will be broken up and the cavity washed out before placing the loop through both incisions and loosely tieing it over the skin |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric patient (0-18 years old) with abscess over 3 cm which can be drained in the ER and does not require hospitalization
Key exclusion criteria (6 listed)
- Diabetes
- immunocompromised
- cancer
- chemotherapy
- requires hospitalization for treatment of abscess
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 |
|---|---|---|
| vessel loopusing the vessel loop to hold the place of the surgical wound that is made during I\&D | Device | Minimally Invasive |
| traditional I&D with or without packingabscess will be drained with a traditional I\&D with or without packing (as deemed appropriate by ER doctor) | Other | Traditional |
Primary outcome
number of patients who require repeat I&D collected by data form
Time frame: 1 week
any patient that needs an additional I\&D procedure noted on data collection forms
Number of patients who Need to have an antibiotic added to treatment plan/or changed antibiotic after the initial visit collected by data form
Time frame: 1 week
any patient requiring the above noted on data collection forms
the number of patients who need to be hospitalized after the first visit collected by data form
Time frame: 1 week
if patient is hospitalized after first visit, as collected on data form
3 secondary outcomes
patient satisfaction with procedure collected by survey
Time frame: 1 day
patient satisfaction with healing of abscess collected by survey
Time frame: 1 month
patient satisfaction with overall treatment of the abscess collected by survey
Time frame: 1 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 20 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Milan Nadkarni, MD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing vessel loop and traditional I&D with or without packing in people with Cutaneous Abscess, run by Wake Forest University Health Sciences.
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 6 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 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
number of patients who require repeat I&D collected by data form (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2019.