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

NCT03735641 | Unknown DMC

• 1 other identifier: KY20182035-C-1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Surgical Flaps; Skin Pigmentation; Sensory Defect

Keywords

Expanded Pedicled Deltopectoral Flap; skin color; Sensory recovery

Outcome Measures

Primary Outcomes (1)

• Flap Color（the value of L*a*b*）

  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)

  3 month later

Secondary Outcomes (8)

• Temperature

  3 month later

• Light Touch

  3 month later

• Two-point Discrimination（2PD）

  3 month later

• Flap Elasticity

  3 month later

• Melanin Content

  3 month later

Study Arms (1)

postoperative

Expanded Pedicled Deltopectoral Flap is a type of surgical flap that has been cut away from surrounding areas for transplantation.The postoperative patients are studied . Tested sensory recovery,skin color and Skin elasticity

Procedure: Expanded Pedicled Deltopectoral Flap

Interventions

Expanded Pedicled Deltopectoral Flap PROCEDURE

Expanded Pedicled Deltopectoral Flap is a type of surgical flap

postoperative

Eligibility Criteria

• Age: 14 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients who underwent Expanded Pedicled Deltopectoral Flap to repair facial-cervical scars in 2006 -2018

You may qualify if:

• Patients who underwent Expanded Pedicled Deltopectoral Flap to repair facial-cervical scars in 2006 -2018.
• In compliance with ethical requirements, patients were voluntarily tested and signed informed consent.

You may not qualify if:

• 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.
• Diabetes

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

The First Affiliated Hospital, the Air Force Medical University

Xi'an, Shaanxi, 710000, China

Location

Related Publications (21)

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• Ma X, Li Y, Li W, Liu C, Peng P, Song B, Xia W, Yi C, Lu K, Su Y. Reconstruction of Large Postburn Facial-Scalp Scars by Expanded Pedicled Deltopectoral Flap and Random Scalp Flap: Technique Improvements to Enlarge the Reconstructive Territory. J Craniofac Surg. 2017 Sep;28(6):1526-1530. doi: 10.1097/SCS.0000000000003902.

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• Ma X, Li Y, Li W, Liu C, Liu H, Xue P, Cui J. Reconstruction of Facial-Cervical Scars With Pedicled Expanded Deltopectoral Flap. J Craniofac Surg. 2017 Sep;28(6):1554-1558. doi: 10.1097/SCS.0000000000003901.

  PMID: 28708657 RESULT

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  PMID: 26595007 RESULT

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• Xie A, Zhang J, Lu A, Yuan J, Wang B, Yang H, Zhang J, Wang H. [Effectiveness of retrograde island neurocutaneous flap pedicled with lateral antebrachial cutaneous nerve in treatment of hand defect]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2014 Dec;28(12):1498-501. Chinese.

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MeSH Terms

Conditions

Pigmentation Disorders

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: November 8, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 8, 2018

Record last verified: 2018-09

Locations

CN (1)