Abscess of Skin and/or Subcutaneous Tissue Clinical Trial
Official title:
Loop vs. Traditional Incision and Drainage: A Randomized Controlled Pilot Trial
This is a multicenter randomized controlled trial of loop drainage versus traditional incision and drainage in adult patients presenting to the emergency department.
BACKGROUND AND SIGNIFICANCE
The usual care in the United States for abscess management is generally incision and
drainage. There have been various techniques described for incision and drainage: 1. incision
and drainage followed by healing by secondary intention, 2. Incision and drainage followed by
primary closure, and 3. Loop drainage (more recently, the topic of this study) with
subsequent loop removal and healing by secondary intention. The treatment failure rate for
traditional incision and drainage is variable, but can range from 10-30%. Costs associated
with treatment failure are between $1,000 and $2,0005. The relatively high failure rate
associated with traditional incision and drainage has led to research into less invasive,
more effective techniques. In 2010, the loop drainage technique was first described. This
technique consists of making 2 small incisions on either end of the abscess cavity followed
by pulling a small drain through the incisions and then tying the drain in place. It remains
in place and is removed once no further drainage is noticed (usually in 10-14 days). Original
studies were primarily done by pediatric surgeons using vessel loops or penrose drains.
In 2014, the concept of using the cuff from the bottom of a sterile glove was introduced.
This allows for this technique to easily be used with materials found easily in any emergency
department. The amount of research done with this technique on adults is limited. To date,
only two studies with a total of 109 patients evaluated loop drainage in adults. One of these
studies was retrospective and included only 63 patients. The other prospective study was
limited in that it included only 46 patients. Given the demonstration of increased clinical
cure rate in pediatric populations and the potential for increased clinical cure rates in
adults, more study into this topic is worthwhile to determine the optimal approach to adult
subcutaneous abscess drainage.
STUDY DESCRIPTION
This study will be a pilot study and multi-center prospective randomized controlled trial
evaluating loop drainage compared to conventional incision and drainage in adults older than
18 who have simple, purulent, cutaneous abscesses deemed amenable to outpatient incision and
drainage by the attending clinician.
Study participants will be randomized to investigational vs control arm in a 1:1 ratio
(Randomization will occur via blocked randomization in blocks of 10). Enrollment will occur
primarily when investigators are on shift (convenience sampling). This study will not be
blinded, however, observer bias will be reduced by having an investigator blinded to
treatment assignment determine the cosmetic healing rate at 90 days.
Participants will receive drainage of their abscess (either conventional or loop). For
conventional drainage, the wound will be incised with a #11 blade scalpel along the point of
maximal fluctuance, approximately 2-3 cm, and then all loculations bluntly dissected with a
set of Kelly clamps. After drainage of pus, the wound will be loosely packed with gauze.
Afterwards, a dry dressing will be placed and the patient will be instructed to change the
external dressing twice daily or every time it becomes saturated. Patients randomized to
standard care will be instructed to remove the packing at 48 hours after incision and
drainage.
Loop drainage will occur via 2 small incisions, approximately 2 cm, with the cuff from the
base of a sterile glove pulled through and then tied off3. The patient will be instructed to
move this cuff back and forth three times daily and cover it with a dry dressing.
Once the abscess drainage procedure is complete, the participant will complete a
questionnaire asking about pain during procedure and satisfaction with the procedure. All
participants will be discharged with a prescription trimethoprim-sulfamethoxazole (TMP-SMX)
160mg/800mg, two tablets by mouth twice daily for ten days. All participants will be
instructed to return to the emergency department and contact the PI if they have any
worsening signs of infection. Between 10 and 14 days after the initial procedure, patients
will follow up in the emergency department for wound recheck. At this visit, the maximal
diameter of both erythema and swelling will be measured, and a questionnaire will be
administered regarding wound care satisfaction, repeat medical visits, fevers, and any side
effects of either the procedure or antibiotic therapy. Loop participants will have the loop
removed at the follow up visit. Participants will be called at 30 days for data collection on
abscess recurrences. Patient will be asked to return for a wound recheck and submit a photo
of the wound, to assess cosmetic appearance of wound at 90 days.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02443272 -
Comparison of Loop Drainage Versus Incision and Drainage for Abscesses in Children
|
N/A | |
| Terminated |
NCT02697279 -
Loop Drainage: Effectiveness in Treating Cutaneous Abscesses
|
N/A |