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

Wounds Clinical Trial

— Catgut  

Official title:

Cosmetic Outcomes of Absorbable Versus Non-absorbable Sutures in Pediatric Facial Lacerations, Part 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681070
• Other study ID #: 11020
• Secondary ID: 11020-2
• Status: Completed
• Phase: N/A
• First received: May 19, 2008
• Last updated: February 8, 2017
• Start date: April 2008
• Est. completion date: September 2010

Study information

• Verified date: February 2017
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: September 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Lacerations
• Wounds

Intervention

Other:
• Arm 2: Absorbable sutures
use of absorbable catgut sutures in pediatric facial lacerations
• Arm 1: non-absorbable sutures
Use of non-absorbing sutures

Locations

Country	Name	City	State
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Cardinal Glennon Children's Hospital	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cosmetic outcomes		3 months
Secondary	infection		4-6 days