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

• Conditions: Skin Pigmentation; Sensory Defect; Surgical Flaps
• Interventions: Procedure: Expanded Pedicled Deltopectoral Flap

• Registration Number: NCT03735641
• Lead Sponsor: Xijing Hospital

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 Timeline

• Status Verified: 2018-09
• Study Start: 2018-10-01
• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-11-07
• Last Update Submitted: 2018-11-07
• Study First Posted: 2018-11-08
• Last Update Posted: 2018-11-08
• Primary Completion: 2019-10
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
postoperative	Expanded Pedicled Deltopectoral Flap	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

Primary Outcome Measures

Name	Time	Method
Flap Color（the value of L*a*b*）	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 Outcome Measures

Name	Time	Method
Flap Elasticity	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.
Melanin Content	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.
Satisfaction questionnaire	3 month later	At least 3 months after the patient's surgery, use a self-made satisfaction questionnaire to obtain patient satisfaction
Scar scaling	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.
Hemoglobin Content	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.
Temperature	3 month later	Test tubes were equilibrated in water at 0◦C (cold) or 45-50 ◦C (warm) and applied for 5 s.
Two-point Discrimination（2PD）	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.
Light Touch	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.

Trial Locations

Locations (1)

The First Affiliated Hospital, the Air Force Medical University; 🇨🇳 Xian, Shaanxi, China