An interventional study of LOOP Technique and Standard incision and drainage in Abscess, sponsored by Orlando Regional Medical Center. Completed. Per ClinicalTrials.gov, last updated 2018-01-12.
Sponsored by Orlando Regional Medical Center · Not applicable, Interventional, and Treatment
This prospective, randomized controlled trial enrolled a convenience sample of adults and children presenting to two Level 1 trauma centers over 12-months with subcutaneous skin abscesses necessitating drainage. Two methods of drainage were compared: 1) the LOOP technique or 2) standard packing technique.
This prospective, randomized controlled trial enrolled a convenience sample of adults and children presenting to two Level 1 trauma centers over 12-months with subcutaneous skin abscesses necessitating drainage. Patients were excluded if the abscess was on the hand, foot, or face or if it required admission or operative intervention. Patients were followed over 10 days to determine the primary outcome of treatment failure defined by need for admission, IV antibiotics, or repeat drainage within 10-day follow-up. The secondary outcomes included ease of procedure, ease of care, pain after insertion and patient satisfaction using a 10-point numeric rating.
152 studies on the registry are indexed under Abscess; 22 are open to participants now.
This study's enrollment of 217 is above the median of 110 across 120 interventional studies indexed under Abscess.
Browse Abscess studies →Orlando Regional Medical Center is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Placement of subcutaneous loop drain
Procedure: LOOP Technique
Standard Incision and Drainage Technique
Procedure: Standard incision and drainage
Placement of subcutaneous loop drain
Incise and drain with placement of packing
Treatment Failure
Need for admission, IV antibiotics, or repeat drainage within 10-day follow-up derived from descriptive nature
Time frame: 10 Days
Procedure Pain
Procedure Pain using Likert scale 1-10
Time frame: At time of procedure
Ease of procedure
Ease of procedure using Likert 1-10 scale
Time frame: At time of procedure
Ease of care
Ease of care using 1-10 Likert scale
Time frame: During 10 days
Pain on follow-up
Pain on follow-up using 1-10 Likert scale
Time frame: 10 days
Patient satisfaction
Patient satisfaction using Patient derived Likert scale
Time frame: During 10 days
No study locations are listed for this record.
Ran from Jan 2009 to primary completion in Nov 2012, 45 months.
Of 21 interventional studies with no phase under Abscess, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 56. This study's 45 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Orlando Regional Medical Center