Clinical trial NCT03080467: Long-Term Outcome of Pediatric Traumatic Wound Repair: Suture Versus Tissue Adhesive
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tissue Adhesives
Laceration
Sutures
Wounds and Injuries
Child
Keywords: Trauma
Laceration
Suture
Cosmesis
Ethyl-2-Cyanoacrylate
Tissue adhesive
Lip lacerations
Skalp lacerations
Facial injuries
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 386
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients after completion of a primary wound repair treatment with suture or tissue adhesive in the Pediatric Emergency Unit

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cosmetic scar appearance
timeFrame: second follow-up visit: 6 till 12 months after wound repair
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Children's University Hospital of Zurich
state: ZH
Study officials:
affiliation: Children's University Hospital of Zurich
name: Clemens M Schiestl, PD
role: PRINCIPAL_INVESTIGATOR
References:
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;2002(3):CD003326. doi: 10.1002/14651858.CD003326.
citation: Singer AJ, Hollander JE, Quinn JV. Evaluation and management of traumatic lacerations. N Engl J Med. 1997 Oct 16;337(16):1142-8. doi: 10.1056/NEJM199710163371607. No abstract available.
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.
citation: Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.
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):242-247. doi: 10.1097/PRS.0b013e3181f959e8.
citation: 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.
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. doi: 10.1111/j.1365-2133.1995.tb16953.x.
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.
citation: Fontana S, Schiestl CM, Landolt MA, Staubli G, von Salis S, Neuhaus K, Mohr C, Elrod J. A Prospective Controlled Study on Long-Term Outcomes of Facial Lacerations in Children. Front Pediatr. 2021 Feb 12;8:616151. doi: 10.3389/fped.2020.616151. eCollection 2020.