NCT02286479

Brief Summary

Skin abscesses are among the most common soft tissue infections cause emergency room visits frequently. Management of abscess drainage and prevent further complications are important entities for emergency physicians. Historically primary incision and drainage (I\&D) technique has found very effective method of abscess drainage, however a novel technique loop drainage holds promising. The purpose of our study is comparison efficacy of I\&D and loop drainage techniques in patients with cutaneous abscess.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 15, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

November 5, 2014

Last Update Submit

August 12, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Abscess Resolution

    7 days

Secondary Outcomes (1)

  • Procedure Time

    intraoperative

Other Outcomes (1)

  • Procedure Pain Intensity

    intraoperative

Study Arms (2)

Incision and Drainage

ACTIVE COMPARATOR

In the incision and drainage group, the abscesses are incised, irrigated by sterile solutions and drained conventionally.

Procedure: Incision and Drainage

Loop drainage

EXPERIMENTAL

In the loop drainage group, two small incision are made on each side of abscess. The pus are drained and septations are seperated by a forceps. Abscess cavitary irrigated by sterile solution. Sterile, non-powder, non-latex surgical gloves cuff is inserted in one incision and taken out from the other insicion. Then two tips of cuff are tied loosely.

Procedure: Loop drainage

Interventions

In the incision and drainage group, the abscesses are incised, irrigated by sterile solutions and drained conventionally.

Incision and Drainage
Loop drainagePROCEDURE

In the loop drainage group, two small incision are made on each side of abscess. The pus are drained and septations are seperated by a forceps. Abscess cavitary irrigated by sterile solution. Sterile, non-powder, non-latex surgical gloves cuff is inserted in one incision and taken out from the other insicion. Then two tips of cuff are tied loosely.

Loop drainage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients presenting to Kocaeli University Emergency Department with cutaneous abscess.
  • Providing written informed consent.

You may not qualify if:

  • Under 18 years of age.
  • Immunosuppressive patients.
  • Using medications have effects on wound healing.
  • Abscess is not recognizable by bedside ultrasound.
  • Lidocaine allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University Medical Faculty Emergency Medicine Department

Kocaeli, 41730, Turkey (Türkiye)

Location

Related Publications (1)

  • Ozturan IU, Dogan NO, Karakayali O, Ozbek AE, Yilmaz S, Pekdemir M, Suner S. Comparison of loop and primary incision & drainage techniques in adult patients with cutaneous abscess: A preliminary, randomized clinical trial. Am J Emerg Med. 2017 Jun;35(6):830-834. doi: 10.1016/j.ajem.2017.01.036. Epub 2017 Jan 22.

MeSH Terms

Interventions

Drainage

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 5, 2014

First Posted

November 7, 2014

Study Start

October 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 15, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations