A Randomized Blinded Trial of Abscess Management With Pac... | NCT01698996

Studies
A Randomized Blinded Trial of Abscess Management With Packing vs No Packing

NCT01698996

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status

Withdrawn

Last Update Posted

Mar 31, 2015Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Uncomplicated Cutaneous Abscess

Interventions

Packing vs No Packing

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Mar 2016Estimated

Completion Date

Not provided

First Submitted Date

Oct 1, 2012

First Submission Date that Met QC Criteria

Oct 1, 2012

First Posted Date

Oct 3, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2015

Last Update Posted Date

Mar 31, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amit Shah, Principal Investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sPrincipal Investigator

Lead Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Adult patients presenting to the emergency department with superficial cutaneous abscesses will be randomized after incision and drainage to standard care with wound packing or no packing to determine if there is a difference in the proportion of complications between the two groups.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No Packing	Active Comparator	No Packing	Procedure: Packing vs No Packing
Packing	Experimental	Packing	Procedure: Packing vs No Packing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Packing vs No Packing	Procedure		No Packing Packing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of complications (defined as a composite of the following: need for repeat incision and drainage by physician, need for admission to hospital, or need for escalation to intravenous antibiotics)		7 days

Secondary Outcomes

Measure	Description	Time Frame
Proportion of wounds "closed" at 1 week (wound size <0.5 cm length and depth and no drainage)		7 days

Other Outcomes

Measure	Description	Time Frame
Proportion of wounds "closed" at 2 weeks (wound size <0.5 cm length and depth and no drainage)		14 days
Pain scores (daily pain scores for first week from patient diary)		7 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥ 18 years
Abscess ≤ 5cm in diameter
Truncal or extremity location

Exclusion Criteria:

Post-operative abscess (abscess in location of operative incision, operation within the last 4 months)
HIV/immunocompromised/transplant recipient/chronic oral steroid use
Fever at triage (temp ≥38 degrees Celsius)
Abscess secondary to Crohn's
Multiple abscesses requiring drainage
Prior participation in the study for the same abscess
Incision and drainage performed with no packing required, or where abscess cavity is <1 cm max diameter
Bartholins/perigenital, perianal, or facial abscesses
Complicated abscesses (fistula, suspicion of muscular extension, consultation/direct referral to general surgery)
Inability to give consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amit P Shah, MD	London Health Sciences Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
London Health Sciences Centre		London	Ontario	N6A 5W9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D000038	Abscess
D000072836	Surgical Wound

Ancestor Terms

ID	Term
D013492	Suppuration
D007239	Infections
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided