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Clinical Trials/NCT03735641
NCT03735641UnknownNot Applicable

Evaluation of the Postoperative Effect of Expanded Pedicled Deltopectoral Flap to Repair the Facial-Cervical Scars

Xijing Hospital1 site in 1 country50 target enrollmentStarted: October 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Flap Color(the value of L*a*b*)

Study Overview

Brief Summary

This study evaluates the effect of Expanded Pedicled Deltopectoral Flap on facial-cervical scars repair, including flap sensation, L*a*b* value,flap's elasticity,melanin content, hemoglobin content, and evaluation of scar and patient, doctor, and third-party satisfaction

Detailed Description

The scars of face and neck caused by burning often show as large faciocervical scar.Important areas of current focus in face and neck scars management are functional outcomes and quality of patient life.The deltopectoral flap was first described by Bakamjian in 1965, and was recognized as one of the first choices for facial reconstruction, as the texture, color of the flap skin is similar to the facial skin. Since the tissue expansion technique was used to the flap, the flap became one of the best choices for the facial defect reconstruction,especially for Asian patients. It can be used with pedicled or free transferred.Complications at the donor or recipient site have been widely reported and often include dilator exposure,the flap blood circulation disorder and delayed healing, but the pattern of sensory recovery ,flap's elasticitycolor change have been studied less well.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Ages
14 Years to 55 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients who underwent Expanded Pedicled Deltopectoral Flap to repair facial-cervical scars in 2006 -
  • In compliance with ethical requirements, patients were voluntarily tested and signed informed consent.

Exclusion Criteria

  • Peripheral neuropathy
  • Serious aphasia or cognitive impairment, and first-degree relatives can not get in touch.
  • Can not follow up
  • Allergic constitution
  • Connective tissue disease
  • Hormone or chemotherapy drugs are being used.

Outcomes

Primary Outcomes

Flap Color(the value of L*a*b*)

Time Frame: 3 month later

The Antera 3D is a camera for image acquisition and analysis of the skin.Every color is expressed in a three-dimensional coordinate system in terms of three units. L\* expresses the luminance and gives the relative brightness of the color ranging from total black (L\* ¼ 0) to total white (L\* ¼ 100).The terms a\* and b\* are coordinates of chromaticity, with a\* representing the balance between green (negative values)and red (positive values) and b\* representing the balance between blue (negative values) and yellow (positive values)

Secondary Outcomes

  • Flap Elasticity(3 month later)
  • Melanin Content(3 month later)
  • Satisfaction questionnaire(3 month later)
  • Scar scaling(6 month later)
  • Hemoglobin Content(3 month later)
  • Temperature(3 month later)
  • Two-point Discrimination(2PD)(3 month later)
  • Light Touch(3 month later)

Investigators

Sponsor
Xijing Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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