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

November 7, 2018 updated by: Xijing Hospital
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xian, Shaanxi, China, 710000
        • The First Affiliated Hospital, the Air Force Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 53 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Peripheral neuropathy
  2. Serious aphasia or cognitive impairment, and first-degree relatives can not get in touch.
  3. Can not follow up
  4. Allergic constitution
  5. Connective tissue disease
  6. Hormone or chemotherapy drugs are being used.
  7. Diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Expanded Pedicled Deltopectoral Flap is a type of surgical flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 month later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temperature
Time Frame: 3 month later
Test tubes were equilibrated in water at 0◦C (cold) or 45-50 ◦C (warm) and applied for 5 s.
3 month later
Light Touch
Time Frame: 3 month later
The tactile sensation of the flap after surgery is assessed by Semmes-Weinstein monofilaments and the change in tactile sense is detected at least 3 months after surgery.
3 month later
Two-point Discrimination（2PD）
Time Frame: 3 month later
Two-point Discrimination of the flap after surgery was assessed by Touch-Test discriminator, and changes in 2PD were detected at least 3 months after surgery.
3 month later
Flap Elasticity
Time Frame: 3 month later
The elasticity of the flap after surgery was assessed by CK-MC960 and the change in elasticity was measured at least 3 months after surgery.
3 month later
Melanin Content
Time Frame: 3 month later
The melanin content of the flap after surgery was evaluated by Antera 3D, and the change of melanin was detected at least 3 months after surgery.
3 month later
Hemoglobin Content
Time Frame: 3 month later
The hemoglobin content of the flap after surgery was evaluated by Antera 3D, and the change of melanin was detected at least 3 months after surgery.
3 month later
Satisfaction questionnaire
Time Frame: 3 month later
At least 3 months after the patient's surgery, use a self-made satisfaction questionnaire to obtain patient satisfaction
3 month later
Scar scaling
Time Frame: 6 month later
The scar around the flap after surgery was evaluated by Patient and Observer Scar Assessment and the scar was assessed at least 6 months after surgery.
6 month later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (Actual)

November 8, 2018

Study Record Updates

Last Update Posted (Actual)

November 8, 2018

Last Update Submitted That Met QC Criteria

November 7, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KY20182035-C-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sensory Defect

Clinical Trials on Expanded Pedicled Deltopectoral Flap

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe