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

NCT ID: NCT00681070

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2010-09-30

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.

Conditions

Lacerations; Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm1: Non-absorbable sutures

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

Group Type: ACTIVE_COMPARATOR

Arm 1: non-absorbable sutures

Intervention Type: OTHER

Use of non-absorbing sutures

Arm 2: Absorbable sutures

use of absorbable sutures in this arm

Group Type: ACTIVE_COMPARATOR

Arm 2: Absorbable sutures

Intervention Type: OTHER

use of absorbable catgut sutures in pediatric facial lacerations

Interventions

Arm 2: Absorbable sutures

use of absorbable catgut sutures in pediatric facial lacerations

Intervention Type: OTHER

Arm 1: non-absorbable sutures

Use of non-absorbing sutures

Intervention Type: OTHER

Other Intervention Names

fast-absorbing catgut 5-0 by Johnson and Johnson

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cardinal Glennon Children's Hospital

St Louis, Missouri, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

11020-2

Identifier Type: -

Identifier Source: secondary_id

11020

Identifier Type: -

Identifier Source: org_study_id