Boston University Medical Center
Boston, Massachusetts, 02118, United States
NCT Number: NCT01897675
Management of abscesses traditionally involves incision and drainage (I&D). Abscesses are frequently are "packed" or stented open with the presence of a wick, and traditional care requires re-visits every 2-3 days to have the packing removed and replaced, until finally the abscess cavity has closed, usually 1-2 weeks after initial presentation.
Recently there have been attempts to employ less invasive techniques for abscess management. One novel technique, "loop drainage", has been reported in case reports/case series for management of a variety of types of abscesses in the surgical subspecialty literature.
We propose to conduct a randomized prospective study comparing the efficacy of the loop drainage technique with the traditional incision and drainage technique of abscess management.
Patients presenting to the main or urgent care areas of the Emergency Department at Boston Medical Center for treatment of an abscess will be considered for enrollment as potential subjects. After the treating clinician identifies the patient as an appropriate subject, a Research Associate (RA) will approach the patient and obtain written informed consent to enroll in the study. The subject will then be randomized to the management arm of either loop drainage or traditional I&D. The clinician will fill out a data sheet describing the abscess characteristics, and then perform either loop drainage or incision and drainage, depending on randomization and the subject will fill out a satisfaction survey. Fourteen days after initial visit, subjects will return for follow-up. The subject will fill out a satisfaction survey, and a study investigator blinded to the treatment group will assess the subject for abscess resolution, cosmetic outcome, number of follow-up visits, and complications.
The study investigators will then compare outcomes between the two study groups.
Looking for future studies?
Notify Me20 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02118, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 14 days
If no, which sign is present (check all that apply):
Time frame: Time 0
How Satisfied is Patient Immediately after Procedure (likert scale) Did Patient Feel Discomfort During Procedure (likert scale)
Time frame: 14 days
Appearance according to wound scale
Wound Scale (presence or absence of)
Time frame: 14 Days
Patient Satisfaction with:
Number of Follow Up Visits (likert scale) Cosmetic Appearance (likert scale) Pain (likert scale) Overall abscess care (likert scale
Time frame: 14 days
Number of follow-up visits made to either Emergency Department or outpatient clinic for abscess care
Time frame: 14 days
need for new incision in the same abscess, extension of the original incision, starting antibiotics, changing antibiotics, admission
Boston Medical Center
Other
Is Loop Drainage of a Cutaneous Abscess in the Emergency Department as Effective as Incision and Drainage With Packing?
Acronym: LoopDrainage
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02545946
Cutaneous Abscess, Disease Attributes
View Trial DetailsNCT01523899
Animal Diseases, Bacterial Infections
Washington D.C., District of Columbia, United States
View Trial DetailsNCT01606657
Abscess, Cutaneous Abscess
Fresno, California, United States
View Trial DetailsNCT01537783
Abscess, Cutaneous Abscess
Boston, Massachusetts, United States
View Trial Details