An interventional study of vessel loop and traditional I&D with or without packing in Cutaneous Abscess, sponsored by Wake Forest University Health Sciences. Completed. Open to participants aged Up to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-20.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
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.
149 studies on the registry are indexed under Abscess; 32 are open to participants now.
This study's enrollment of 3 is below the median of 96 across 102 interventional studies indexed under Abscess.
Browse Abscess studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Other: traditional I&D with or without packing
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
Device: vessel loop
using the vessel loop to hold the place of the surgical wound that is made during I\&D
abscess will be drained with a traditional I\&D with or without packing (as deemed appropriate by ER doctor)
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
Time frame: 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
Time frame: 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
Time frame: 1 week
patient satisfaction with procedure collected by survey
1-100 scale of satisfaction survey with the drainage performed
Time frame: 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
Time frame: 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
Time frame: 1 month
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Wake Forest University Health Sciences