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

NCT03080467 | Completed DMC

• 1 other identifier: 2016-01304
• Study Type: observational
• Target: 386
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Suture

Wound repair with suture

Tissue adhesive

Wound repair with tissue adhesive

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

Children's University Hospital of Zurich

Zurich, Canton of Zurich, 8032, Switzerland

Location

Related Publications (9)

• 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.

  PMID: 12137689 BACKGROUND

• 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.

  PMID: 9329936 BACKGROUND

• 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.

  PMID: 19152571 BACKGROUND

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

  PMID: 20596233 BACKGROUND

• 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.

  PMID: 21200219 BACKGROUND

• 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.

  PMID: 19501559 BACKGROUND

• 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.

  PMID: 7662573 BACKGROUND

• 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.

  PMID: 26686685 BACKGROUND

• 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.

  PMID: 33643965 DERIVED

MeSH Terms

Conditions

Lacerations; Wounds and Injuries; Facial Injuries

Condition Hierarchy (Ancestors)

Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases

Study Officials

• Clemens M Schiestl, PD

  Children's University Hospital of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 15, 2017
• Study Start: June 13, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

CH (1)