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
NCT number | NCT03080467 |
Other study ID # | 2016-01304 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 13, 2017 |
Est. completion date | July 31, 2019 |
Verified date | August 2019 |
Source | University Children's Hospital, Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Children's University Hospital of Zurich | Zurich | ZH |
Lead Sponsor | Collaborator |
---|---|
University Children's Hospital, Zurich |
Switzerland,
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
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 |
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