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

This study has been completed.
Sponsor:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00681070
First received: May 19, 2008
Last updated: September 24, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Lacerations
Wounds
Other: fast-absorbing catgut

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

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • cosmetic outcomes [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • infection [ Time Frame: 4-6 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 74
Study Start Date: April 2008
Study Completion Date: September 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
use of non-absorbable sutures in facial laceration in this arm
Other: fast-absorbing catgut
use of absorbable sutures in pediatric facial lacerations
Other Name: fast-absorbing catgut 5-0 by Johnson and Johnson
Active Comparator: 2
use of absorbable sutures in this arm
Other: fast-absorbing catgut
use of absorbable sutures in pediatric facial lacerations
Other Name: fast-absorbing catgut 5-0 by Johnson and Johnson

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.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681070

Locations
United States, Missouri
Cardinal Glennon Children's Hospital
St. Louis, Missouri, United States, 63104
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19130
Sponsors and Collaborators
Temple University
  More Information

No publications provided

Responsible Party: Raemma Paredes Luck, Temple University
ClinicalTrials.gov Identifier: NCT00681070     History of Changes
Other Study ID Numbers: 11020, 11020-2
Study First Received: May 19, 2008
Last Updated: September 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
laceration
wound management
absorbable sutures
cosmetic outcomes

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries

ClinicalTrials.gov processed this record on July 28, 2014