Clinical trial NCT03735641: Evaluation of the Postoperative Effect of Expanded Pedicled Deltopectoral Flap to Repair the Facial-Cervical Scars
Official title: Evaluation of the Postoperative Effect of Expanded Pedicled Deltopectoral Flap to Repair the Facial-Cervical Scars
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgical Flaps
Skin Pigmentation
Sensory Defect
Keywords: Expanded Pedicled Deltopectoral Flap
skin color
Sensory recovery
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent Expanded Pedicled Deltopectoral Flap to repair facial-cervical scars in 2006 -2018

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.

Eligibility criteria: 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

Primary outcomes:
measure: Flap Color（the value of L*a*b*）
timeFrame: 3 month later
Secondary outcomes:
measure: Temperature
timeFrame: 3 month later
measure: Light Touch
timeFrame: 3 month later
measure: Two-point Discrimination（2PD）
timeFrame: 3 month later
measure: Flap Elasticity
timeFrame: 3 month later
measure: Melanin Content
timeFrame: 3 month later
measure: Hemoglobin Content
timeFrame: 3 month later
measure: Satisfaction questionnaire
timeFrame: 3 month later
measure: Scar scaling
timeFrame: 6 month later
Other outcomes:
Locations:
city: Xian
country: China
facility: The First Affiliated Hospital, the Air Force Medical University
state: Shaanxi
Study officials:
References:
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