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.

Trial of Abscess Drainage Techniques

Cutaneous Abscess

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.

vessel loop

traditional I&D with or without packing

Traditional Incision and Drainage of Cutaneous Abscess Vs. Minimally Invasive Incision and Drainage With Vessel Loop: A Randomized Control Trial.

any patient that needs an additional I&D procedure noted on data collection forms

any patient requiring the above noted on data collection forms

if patient is hospitalized after first visit, as collected on data form

1-100 scale of satisfaction survey with the drainage performed

1-100 scale survey of how satisfied patient is with how the drainage site healed

1-100 scale survey for how satisfied patient is with overall care related to abscess

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

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

Trial of Abscess Drainage Techniques

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?