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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00681070
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : February 10, 2017
Information provided by (Responsible Party):
Temple University

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.

Condition or disease Intervention/treatment Phase
Lacerations Wounds Other: Arm 2: Absorbable sutures Other: Arm 1: non-absorbable sutures Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cosmetic Outcomes of Absorbable Versus Non-absorbable Sutures in Pediatric Facial Lacerations, Part 2
Actual Study Start Date : April 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics Tears
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm1: Non-absorbable sutures
use of non-absorbable sutures in facial laceration in this arm
Other: Arm 1: non-absorbable sutures
Use of non-absorbing sutures
Active Comparator: Arm 2: Absorbable sutures
use of absorbable sutures in this arm
Other: Arm 2: Absorbable sutures
use of absorbable catgut sutures in pediatric facial lacerations
Other Name: fast-absorbing catgut 5-0 by Johnson and Johnson

Primary Outcome Measures :
  1. cosmetic outcomes [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. infection [ Time Frame: 4-6 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00681070

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

Responsible Party: Temple University Identifier: NCT00681070     History of Changes
Other Study ID Numbers: 11020
First Posted: May 21, 2008    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

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

Additional relevant MeSH terms:
Wounds and Injuries