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

History of Changes

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

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:

ELLIS M. Incision and primary suture of abscesses of the anal region. Proc R Soc Med. 1960 Aug;53:652-3. No abstract available.

Khanna YK, Khanna A, Singh SP, Laddha BL, Prasad P, Jhanji RN. Primary closure of gluteal injection abscess (a study of 100 cases). J Postgrad Med. 1984 Apr;30(2):105-10. No abstract available.

Ajao OG, Ladipo JK, al-Saigh AA, Malatani T. Primary closure of breast abscess compared with the conventional gauze packing and daily dressings. West Afr J Med. 1994 Jan-Mar;13(1):28-30.

Stewart MP, Laing MR, Krukowski ZH. Treatment of acute abscesses by incision, curettage and primary suture without antibiotics: a controlled clinical trial. Br J Surg. 1985 Jan;72(1):66-7.

Edino ST, Ihezue CH, Obekpa PO. Outcome of primary closure of incised acute soft-tissue abscesses. Niger Postgrad Med J. 2001 Mar;8(1):32-6.

Abraham N, Doudle M, Carson P. Open versus closed surgical treatment of abscesses: a controlled clinical trial. Aust N Z J Surg. 1997 Apr;67(4):173-6.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Singer AJ, Taira BR, Chale S, Bhat R, Kennedy D, Schmitz G. Primary versus secondary closure of cutaneous abscesses in the emergency department: a randomized controlled trial. Acad Emerg Med. 2013 Jan;20(1):27-32. doi: 10.1111/acem.12053.

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
Suppuration
Infection
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013

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