Comparison of Cosmetic Outcomes of Lacerations Repaired Using Absorbable Versus Non-absorbable Sutures
Primary Purpose
Lacerations, Wounds, Injuries
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Absorbable Suture Arm
Non-absorbable suture (Prolene)
suture
Sponsored by
About this trial
This is an interventional treatment trial for Lacerations focused on measuring absorbable sutures, non-absorbable sutures, wound management
Eligibility Criteria
Inclusion Criteria:
- Isolated injury
- Non-contaminated or minimally contaminated wounds
- Linear laceration 1-5 cms
- Topical adhesives not indicated
Exclusion Criteria:
- Trunk and extremity lacerations less than 1 cm or greater than 5 cm.
- Moderately contaminated wounds or dirty wounds
- Wounds with visible foreign bodies
- Wounds more than 8 hours old
- Wounds that can be repaired using topical adhesives
- Complex wounds needing surgical referral
- Wounds caused by mammalian bites
- Wounds in patients with immune deficiency, pregnancy, diabetes, suspected bleeding disorder or renal dysfunction
- Wounds in patients who are currently taking steroids
- Wounds in areas of tension such as the joint or crease
- Patients with allergic reaction to the topical anesthetic
- Irregular wounds
Sites / Locations
- Temple University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Non-absorbable arm
Absorbable Suture Arm
Arm Description
uses non-absorbable suture such as Prolene to repair lacerations
uses absorbable sutures to repair lacerations
Outcomes
Primary Outcome Measures
The primary outcome is cosmetic outcomes at 3 to 4 months using the visual analogue scale.
Secondary Outcome Measures
Secondary outcome measures: complication rates such as infection and dehiscence rates at the first visit post-injury.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00933829
Brief Title
Comparison of Cosmetic Outcomes of Lacerations Repaired Using Absorbable Versus Non-absorbable Sutures
Official Title
Comparison of Cosmetic Outcomes of Lacerations of the Trunk and Extremity Repaired Using Absorbable Versus Non-absorbable Sutures
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Withdrawn
Study Start Date
April 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this prospective, randomized study is to compare cosmetic outcomes between absorbable and non-absorbable sutures in truncal and extremity lacerations in the pediatric and adult population. Secondary outcome measures include wound complications such as infection and wound dehiscence at the initial visit; and parental satisfaction and keloid formation after three months post repair.
Detailed Description
Even though there some studies showing good outcomes using absorbable sutures in skin closure in clean surgical wounds, ED based studies still need to be conducted to convince ED physicians that the use of absorbable sutures to close the skin in traumatic lacerations are just as acceptable as traditional non-absorbable sutures. Use of absorbable sutures confers several advantages over non-absorbable sutures. For one, patients do not need an additional physician visit either in the office, or more often that not, in the emergency department. These visits add to ED overcrowding, prolonged length of ED stay and are often not reimbursed if seen in the emergency department. Moreover, adult patients need to miss work or school and children often have to miss school or daycare to have these sutures removed. The potential to avert another traumatic experience from suture removal in children who had been restrained for suture placement is another advantage of using absorbable sutures over non-absorbable sutures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lacerations, Wounds, Injuries
Keywords
absorbable sutures, non-absorbable sutures, wound management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-absorbable arm
Arm Type
Placebo Comparator
Arm Description
uses non-absorbable suture such as Prolene to repair lacerations
Arm Title
Absorbable Suture Arm
Arm Type
Active Comparator
Arm Description
uses absorbable sutures to repair lacerations
Intervention Type
Procedure
Intervention Name(s)
Absorbable Suture Arm
Other Intervention Name(s)
Vicryl Rapide
Intervention Description
use of irradiated polyglactin 910
Intervention Type
Device
Intervention Name(s)
Non-absorbable suture (Prolene)
Intervention Description
suture
Intervention Type
Procedure
Intervention Name(s)
suture
Intervention Description
non-absorable sutures and absorable sutures
Primary Outcome Measure Information:
Title
The primary outcome is cosmetic outcomes at 3 to 4 months using the visual analogue scale.
Time Frame
at least 3 months post-injury
Secondary Outcome Measure Information:
Title
Secondary outcome measures: complication rates such as infection and dehiscence rates at the first visit post-injury.
Time Frame
8-12 days post-injury
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Isolated injury
Non-contaminated or minimally contaminated wounds
Linear laceration 1-5 cms
Topical adhesives not indicated
Exclusion Criteria:
Trunk and extremity lacerations less than 1 cm or greater than 5 cm.
Moderately contaminated wounds or dirty wounds
Wounds with visible foreign bodies
Wounds more than 8 hours old
Wounds that can be repaired using topical adhesives
Complex wounds needing surgical referral
Wounds caused by mammalian bites
Wounds in patients with immune deficiency, pregnancy, diabetes, suspected bleeding disorder or renal dysfunction
Wounds in patients who are currently taking steroids
Wounds in areas of tension such as the joint or crease
Patients with allergic reaction to the topical anesthetic
Irregular wounds
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raemma p Luck, MD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15620501
Citation
Al-Qattan MM. Vicryl Rapide versus Vicryl suture in skin closure of the hand in children: a randomized prospective study. J Hand Surg Br. 2005 Feb;30(1):90-1. doi: 10.1016/j.jhsb.2004.08.005.
Results Reference
result
PubMed Identifier
25039547
Citation
Tejani C, Sivitz AB, Rosen MD, Nakanishi AK, Flood RG, Clott MA, Saccone PG, Luck RP. A comparison of cosmetic outcomes of lacerations on the extremities and trunk using absorbable versus nonabsorbable sutures. Acad Emerg Med. 2014 Jun;21(6):637-43. doi: 10.1111/acem.12387.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/sites/entrez
Description
abstract of Vicryl Rapide and RCT
URL
http://emergency-medicine.jwatch.org/cgi/content/full/2008/425/1
Description
use of absorbable sutures in pediatric facial lacerations
URL
http://emedicine.medscape.com/article/884838-overview
Description
review of wound management, sutures
Learn more about this trial
Comparison of Cosmetic Outcomes of Lacerations Repaired Using Absorbable Versus Non-absorbable Sutures
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