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Comparison of Suturing and Packing of Drained Abscesses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adam Singer, Stony Brook University
ClinicalTrials.gov Identifier:
NCT00465049
First received: April 23, 2007
Last updated: October 19, 2012
Last verified: October 2012
  Purpose

The standard treatment for skin abscesses in drainage followed by packing to prevent premature closure and reaccumulation of pus. Studies from the 1950s and later conducted outside of the US suggest that when drained abscesses are drained and sutured closed they actually heal faster without complications. The current study compares the time to healing and scar formation when drained abscesses are packed or sutured.


Condition Intervention Phase
Cutanoeus Abscesses
Other: PRIMARY CLOSRE
Other: SECONDARY CLOSURE
Other: SPONTANEOUS HALING
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Primary vs. Secondary Closure of Cutaneous Abscesses After I&D: A RCT

Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • Days to healing. [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Need for subsequent drainage, scar appearance. [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2007
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: primary closure
suture after I&D
Other: PRIMARY CLOSRE
SUTURE
Placebo Comparator: SECONDARY CLOSURE
LEAVE TO HEAL BY SECONDARY INTENTIN AFTER I&D
Other: SECONDARY CLOSURE
ALLOW TO HEAL SPONTANEOUSLY
Other: SPONTANEOUS HALING
SECONDARY HEALING AFTER I&D

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non complicated abscesses

Exclusion Criteria:

  • Fever,
  • Immunocompromise,
  • Cellulitis,
  • Perianal and
  • Pilonidal abscesses
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465049

Locations
United States, New York
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
Investigators
Principal Investigator: Adam J Singer, MD Stony Brook University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Adam Singer, RESEARCH DIRECTOR, Stony Brook University
ClinicalTrials.gov Identifier: NCT00465049     History of Changes
Other Study ID Numbers: CORIHS 2007-5819
Study First Received: April 23, 2007
Last Updated: October 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stony Brook University:
abscess, primary closure, secondary closure

Additional relevant MeSH terms:
Abscess
Infection
Inflammation
Pathologic Processes
Suppuration

ClinicalTrials.gov processed this record on November 20, 2014