Trial Outcomes & Findings for The Effect Of Wound Irrigation With Irrisept™ Delivery System On Abscess Healing In Patients Presenting To The Emergency Department (NCT NCT01302548)

Results Overview

The abscess healing process will use two methods: 1) "usual method" includes saline irrigation and/or incision \& drainage, and 2) the use of IRRISEPT solution. The Abscess Measurement Scale was measured using a centimeter ruler. Scale 8cm - 10cm = Severe 6cm - 8cm = Moderate/severe 4cm - 6cm = Moderate 2cm - 4cm = Mild/moderate 0cm - 2cm = Mild

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

48 hours

Results posted on

2014-04-07

Participant Flow

Participant milestones

Participant milestones
Measure	IRRISEPT Device containing sterile water and chlorhexidine gluconate (CHG)	Usual Care The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
Overall Study STARTED	14	19
Overall Study COMPLETED	12	18
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	IRRISEPT Device containing sterile water and chlorhexidine gluconate (CHG)	Usual Care The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

The Effect Of Wound Irrigation With Irrisept™ Delivery System On Abscess Healing In Patients Presenting To The Emergency Department

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IRRISEPT n=14 Participants Device containing sterile water and chlorhexidine gluconate (CHG)	Usual Care n=19 Participants The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32.42 years STANDARD_DEVIATION 9.04 • n=5 Participants	24.83 years STANDARD_DEVIATION 9.81 • n=7 Participants	27.87 years STANDARD_DEVIATION 10.08 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	19 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

The abscess healing process will use two methods: 1) "usual method" includes saline irrigation and/or incision \& drainage, and 2) the use of IRRISEPT solution. The Abscess Measurement Scale was measured using a centimeter ruler. Scale 8cm - 10cm = Severe 6cm - 8cm = Moderate/severe 4cm - 6cm = Moderate 2cm - 4cm = Mild/moderate 0cm - 2cm = Mild

Outcome measures

Outcome measures
Measure	IRRISEPT n=12 Participants Device containing sterile water and chlorhexidine gluconate (CHG)	Usual Care n=18 Participants The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
Abscess Healing Based on Abscess Measurement Scale	2.750 units on a scale Standard Deviation 0.6216	2.833 units on a scale Standard Deviation 0.9852

SECONDARY outcome

Timeframe: 48 hours

Number of patients prescribed oral antibiotics

Outcome measures

Outcome measures
Measure	IRRISEPT n=12 Participants Device containing sterile water and chlorhexidine gluconate (CHG)	Usual Care n=18 Participants The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
Number of Patients Prescribed Oral Antibiotics	1 participants	5 participants

SECONDARY outcome

Timeframe: 48 hours

Population: Only participants that were MRSA-positive, were analyzed.

The Abscess Measurement Scale was measured using a centimeter ruler. Scale 8cm - 10cm = Severe 6cm - 8cm = Moderate/severe 4cm - 6cm = Moderate 2cm - 4cm = Mild/moderate 0cm - 2cm = Mild

Outcome measures

Outcome measures
Measure	IRRISEPT n=5 Participants Device containing sterile water and chlorhexidine gluconate (CHG)	Usual Care n=1 Participants The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
Abscess Measurement Using a Abscess Measurement Scale in Methicillin-resistant Staphylococcus Aureus (MRSA) Positive Patients.	2.4 units on a scale Standard Deviation .5477	2.0 units on a scale Standard Deviation NA There was only one patient in this group.

Adverse Events

IRRISEPT

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IRRISEPT n=14 participants at risk Device containing sterile water and chlorhexidine gluconate (CHG)	Usual Care n=19 participants at risk The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
Skin and subcutaneous tissue disorders Increased Pain	7.1% 1/14 • Number of events 1 • 02/26/2011 - 08/09/2012	0.00% 0/19 • 02/26/2011 - 08/09/2012

Additional Information

Richard F Petrik, MD

University of Florida

Phone: 352-265-5911

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place