Ignite Creation Date:
2024-05-06 @ 8:14 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02697279
Status:
TERMINATED
Last Update Posted:
2022-01-05
First Post:
2016-02-04
Brief Title:
Loop Drainage Effectiveness in Treating Cutaneous Abscesses
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Evaluation of Loop Drainage Technique Versus Standard Incision and Drainage for Treatment of Simple Soft Tissue Abscesses
Status:
TERMINATED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to enroll the appropriate number of subjects within a reasonable timeframe
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In the Emergency Department ED patients frequently seek medical treatment for cutaneous abscesses Traditional incision and drainage ID with or without packing of cutaneous abscesses has long been the accepted standard of care This procedure is often very painful for the patient Additionally compliance with wound care and follow-up can present barriers to proper care and healing Research has suggested that incision and loop drainage of an abscess may be another effective treatment for simple cutaneous abscess Thus far research into this procedure has been limited to the pediatric population with small sample sizes In these previous studies this technique was found to be an effective and less painful treatment for abscesses Research has not been done in the adult population using this procedure If this procedure is found to be as effective and less painful in the adult population then it should be considered as a potential preferred ID method for cutaneous abscess in the ED
Detailed Description:
Patients who meet study criteria for treatment of a simple cutaneous abscess and desire to be a part of this study will be consented Study subjects will be enrolled and randomly assigned to either the study or control groups
Control Group- standard I D method for cutaneous abscess
Study Group- Loop Technique
1 Gather all of your material and bring to bedside
2 Clean area with chlorhexidine or iodine swabs
3 Anesthetize area
4 Use your scalpel to make small 5mm incision at most fluctuant area of abscess
5 Explore cavity with your hemostat and break down loculations
6 Make second incision less than 4cm away from first incision Feel borders of abscess and try to make second incision as far within cavity as you can
7 For larger abscesses can repeat step 5 thus creating several LOOPs
8 Irrigate cavity with saline flush
9 Pass hemostat through both incisions and pull loop vessel penrose or bottom of glove through Keep your loop device equal in length on both sides
10 Tie loop device loosely over 30cc syringe to form LOOP Usually 5-6 knots This helps prevent loop from falling out prematurely
11 Slide syringe out and trim free ends of loop Make sure loop is mobile
12 Cover site with dry dressing Follow-Up-
Wound check in 1-2 days
Patient may manage drain at home by rotating it to facilitate drainage and prevent adhesion
Patient will be instructed to return to the Emergency Department for drain removal in 5-7 days
Control Group- standard I D method for cutaneous abscess
Study Group- Loop Technique
1 Gather all of your material and bring to bedside
2 Clean area with chlorhexidine or iodine swabs
3 Anesthetize area
4 Use your scalpel to make small 5mm incision at most fluctuant area of abscess
5 Explore cavity with your hemostat and break down loculations
6 Make second incision less than 4cm away from first incision Feel borders of abscess and try to make second incision as far within cavity as you can
7 For larger abscesses can repeat step 5 thus creating several LOOPs
8 Irrigate cavity with saline flush
9 Pass hemostat through both incisions and pull loop vessel penrose or bottom of glove through Keep your loop device equal in length on both sides
10 Tie loop device loosely over 30cc syringe to form LOOP Usually 5-6 knots This helps prevent loop from falling out prematurely
11 Slide syringe out and trim free ends of loop Make sure loop is mobile
12 Cover site with dry dressing Follow-Up-
Wound check in 1-2 days
Patient may manage drain at home by rotating it to facilitate drainage and prevent adhesion
Patient will be instructed to return to the Emergency Department for drain removal in 5-7 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None