Long-Term Outcome of Pediatric Traumatic Wound Repair: Suture Versus Tissue Adhesive

Child Clinical Trial

Official title:

Long-term Outcome of the Primary Wound Repair of Traumatic Skin Lacerations in the Head Area in Pediatric Patients: Suture Versus Tissue Adhesive

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080467
• Other study ID #: 2016-01304
• Status: Completed
• Start date: June 13, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2019
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This project is an observational trial investigating wound cosmetic appearance after repair of traumatic skin lacerations in the head area of pediatric patients with two different approaches to skin closure: sutures versus tissue adhesive. Photographs will be taken at two follow-up visits after repair and later assessed by external blinded plastic surgeon using standard cosmetic assessment scales. The investigators hypothesize that cosmetic wound outcome will be equivalent in these two wound repair treatment options.

Description:

Investigation of the long-term outcome of 300 pediatric patients with traumatic skin lacerations in the head area. After primary wound repair with suture or with tissue adhesive, eligible patients will be enrolled on the emergency department (baseline visit). The second follow-up visit will take place 5-10 days after the baseline visit and the third follow-up visit will be completed 6-12 months after trauma. At both follow-up visits, clinical examination and a brief interview will be performed. Photo documentation is completed at both the baseline and the follow-up visit.

Encrypted photo documentation will be evaluated by blinded external plastic surgeons. Primary Outcome is the cosmetic appearance using standard assessment scales, secondary outcomes are the occurrence of complications, cost-effectiveness and patient's satisfaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

• 0 till16 years of age

• Any primary wound repair treatment of a laceration caused by trauma and involving the skin of the head area

• Patient or caregiver must be able to understand and sign an informed consent

Exclusion Criteria:

• Pre-existing conditions that affect wound healing adversely

• Patients who demonstrate severe or life-threatening injuries

• Patients / caregivers with communication / logistic barriers that would make them unfit to provide informed consent or to attend the follow-up visits

Related Conditions & MeSH terms

• Child
• Laceration
• Lacerations
• Sutures
• Tissue Adhesives
• Wounds and Injuries

Locations

Country	Name	City	State
Switzerland	Children's University Hospital of Zurich	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (8)

Brown BC, Moss TP, McGrouther DA, Bayat A. Skin scar preconceptions must be challenged: importance of self-perception in skin scarring. J Plast Reconstr Aesthet Surg. 2010 Jun;63(6):1022-9. doi: 10.1016/j.bjps.2009.03.019. Epub 2009 Jun 5. — View Citation

Farion K, Osmond MH, Hartling L, Russell K, Klassen T, Crumley E, Wiebe N. Tissue adhesives for traumatic lacerations in children and adults. Cochrane Database Syst Rev. 2002;(3):CD003326. Review. — View Citation

Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43. — View Citation

Fearmonti RM, Bond JE, Erdmann D, Levin LS, Pizzo SV, Levinson H. The modified Patient and Observer Scar Assessment Scale: a novel approach to defining pathologic and nonpathologic scarring. Plast Reconstr Surg. 2011 Jan;127(1):242-7. doi: 10.1097/PRS.0b013e3181f959e8. — View Citation

Idriss N, Maibach HI. Scar assessment scales: a dermatologic overview. Skin Res Technol. 2009 Feb;15(1):1-5. doi: 10.1111/j.1600-0846.2008.00327.x. Review. — View Citation

Lewis-Jones MS, Finlay AY. The Children's Dermatology Life Quality Index (CDLQI): initial validation and practical use. Br J Dermatol. 1995 Jun;132(6):942-9. — View Citation

Olsen JR, Gallacher J, Finlay AY, Piguet V, Francis NA. Quality of life impact of childhood skin conditions measured using the Children's Dermatology Life Quality Index (CDLQI): a meta-analysis. Br J Dermatol. 2016 Apr;174(4):853-61. doi: 10.1111/bjd.14361. Epub 2016 Mar 6. Review. — View Citation

Singer AJ, Hollander JE, Quinn JV. Evaluation and management of traumatic lacerations. N Engl J Med. 1997 Oct 16;337(16):1142-8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cosmetic scar appearance	Cosmetic appearance will be assessed using the modified Patient and Observer Scar Measurement Score	second follow-up visit: 6 till 12 months after wound repair