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Cosmetic Outcomes of Absorbable Versus Non-absorbable Sutures in Pediatric Facial Lacerations (Catgut)

Primary Purpose

Lacerations, Wounds

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arm 2: Absorbable sutures
Arm 1: non-absorbable sutures
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lacerations focused on measuring laceration, wound management, absorbable sutures, cosmetic outcomes

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Clean. minimally contaminated facial lacerations, between 1-5 cms long, less than 8 hours old, not caused by animal bites, not needing plastic surgery repair

Exclusion Criteria:

  • Pregnancy
  • Bleeding
  • Renal
  • Endocrine problems
  • Dirty wounds
  • Irregular wounds

Sites / Locations

  • Cardinal Glennon Children's Hospital
  • Temple University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm1: Non-absorbable sutures

Arm 2: Absorbable sutures

Arm Description

use of non-absorbable sutures in facial laceration in this arm

use of absorbable sutures in this arm

Outcomes

Primary Outcome Measures

cosmetic outcomes

Secondary Outcome Measures

infection

Full Information

First Posted
May 19, 2008
Last Updated
February 8, 2017
Sponsor
Temple University
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1. Study Identification

Unique Protocol Identification Number
NCT00681070
Brief Title
Cosmetic Outcomes of Absorbable Versus Non-absorbable Sutures in Pediatric Facial Lacerations
Acronym
Catgut
Official Title
Cosmetic Outcomes of Absorbable Versus Non-absorbable Sutures in Pediatric Facial Lacerations, Part 2
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2008 (Actual)
Primary Completion Date
April 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
Our research hypothesis in this study is that there is no difference in long-term cosmetic outcomes between absorbable sutures and non-absorbable sutures in the repair of pediatric facial lacerations.
Detailed Description
The standard method of repair for facial lacerations is to close such wounds with non-absorbable sutures. Recently, topical skin adhesives such as n-butyl-2-cyanoacrylate and 2-octyl cyanoacrylate have been used more frequently as these have been shown to be a faster and less painful way to close superficial facial lacerations. However, lacerations that are deeper, gaping or occurring along lines of excessive tension, such as the chin, still need sutures for repair. Non-absorbable sutures have to be taken out at 4-7 days. This involves another physician visit, parental absence from work, and children who need to be taken out of school or daycare for a simple suture removal. In Part Iof the study, we were able to demonstrate non-inferiority of absorbable sutures to nylon sutures. However, we purposely removed all remaining absorbable sutures on the 5-7 day follow-up visit. In Part II, we will allow the absorbable sutures to dissolve on their own. We will again assess long term cosmetic outcomes, as well parental satisfaction, and short and long-term complication rates at 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lacerations, Wounds
Keywords
laceration, wound management, absorbable sutures, cosmetic outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm1: Non-absorbable sutures
Arm Type
Active Comparator
Arm Description
use of non-absorbable sutures in facial laceration in this arm
Arm Title
Arm 2: Absorbable sutures
Arm Type
Active Comparator
Arm Description
use of absorbable sutures in this arm
Intervention Type
Other
Intervention Name(s)
Arm 2: Absorbable sutures
Other Intervention Name(s)
fast-absorbing catgut 5-0 by Johnson and Johnson
Intervention Description
use of absorbable catgut sutures in pediatric facial lacerations
Intervention Type
Other
Intervention Name(s)
Arm 1: non-absorbable sutures
Intervention Description
Use of non-absorbing sutures
Primary Outcome Measure Information:
Title
cosmetic outcomes
Time Frame
3 months
Secondary Outcome Measure Information:
Title
infection
Time Frame
4-6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clean. minimally contaminated facial lacerations, between 1-5 cms long, less than 8 hours old, not caused by animal bites, not needing plastic surgery repair Exclusion Criteria: Pregnancy Bleeding Renal Endocrine problems Dirty wounds Irregular wounds
Facility Information:
Facility Name
Cardinal Glennon Children's Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19130
Country
United States

12. IPD Sharing Statement

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Cosmetic Outcomes of Absorbable Versus Non-absorbable Sutures in Pediatric Facial Lacerations

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