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Comparison of Suturing and Packing of Drained Abscesses

Primary Purpose

Cutanoeus Abscesses

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PRIMARY CLOSRE
SECONDARY CLOSURE
SPONTANEOUS HALING
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutanoeus Abscesses focused on measuring abscess, primary closure, secondary closure

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Non complicated abscesses

Exclusion Criteria:

  • Fever,
  • Immunocompromise,
  • Cellulitis,
  • Perianal and
  • Pilonidal abscesses

Sites / Locations

  • Stony Brook University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

primary closure

SECONDARY CLOSURE

Arm Description

suture after I&D

LEAVE TO HEAL BY SECONDARY INTENTIN AFTER I&D

Outcomes

Primary Outcome Measures

Days to healing.

Secondary Outcome Measures

Need for subsequent drainage, scar appearance.

Full Information

First Posted
April 23, 2007
Last Updated
October 19, 2012
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT00465049
Brief Title
Comparison of Suturing and Packing of Drained Abscesses
Official Title
Primary vs. Secondary Closure of Cutaneous Abscesses After I&D: A RCT
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutanoeus Abscesses
Keywords
abscess, primary closure, secondary closure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
primary closure
Arm Type
Experimental
Arm Description
suture after I&D
Arm Title
SECONDARY CLOSURE
Arm Type
Placebo Comparator
Arm Description
LEAVE TO HEAL BY SECONDARY INTENTIN AFTER I&D
Intervention Type
Other
Intervention Name(s)
PRIMARY CLOSRE
Intervention Description
SUTURE
Intervention Type
Other
Intervention Name(s)
SECONDARY CLOSURE
Intervention Description
ALLOW TO HEAL SPONTANEOUSLY
Intervention Type
Other
Intervention Name(s)
SPONTANEOUS HALING
Intervention Description
SECONDARY HEALING AFTER I&D
Primary Outcome Measure Information:
Title
Days to healing.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Need for subsequent drainage, scar appearance.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non complicated abscesses Exclusion Criteria: Fever, Immunocompromise, Cellulitis, Perianal and Pilonidal abscesses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam J Singer, MD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
13726484
Citation
ELLIS M. Incision and primary suture of abscesses of the anal region. Proc R Soc Med. 1960 Aug;53(8):652-3. No abstract available.
Results Reference
background
PubMed Identifier
6527292
Citation
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.
Results Reference
background
PubMed Identifier
8080827
Citation
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.
Results Reference
background
PubMed Identifier
3881155
Citation
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. doi: 10.1002/bjs.1800720125.
Results Reference
background
PubMed Identifier
11487781
Citation
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.
Results Reference
background
PubMed Identifier
9137156
Citation
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. doi: 10.1111/j.1445-2197.1997.tb01934.x.
Results Reference
background
PubMed Identifier
23570475
Citation
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.
Results Reference
derived

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Comparison of Suturing and Packing of Drained Abscesses

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