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

Skin Pigmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03735641
• Other study ID #: KY20182035-C-1
• Status: Enrolling by invitation
• Start date: October 1, 2018
• Est. completion date: November 2019

Study information

• Verified date: September 2018
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: November 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Sensory Defect
• Skin Pigmentation
• Surgical Flaps

Intervention

Procedure:
• Expanded Pedicled Deltopectoral Flap
Expanded Pedicled Deltopectoral Flap is a type of surgical flap

Locations

Country	Name	City	State
China	The First Affiliated Hospital, the Air Force Medical University	Xian	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (21)

Abrar Y, Muntaha ST, Khan K, Hameed U. Successful Use of Deltopectoral Flap in Reconstruction of Defect Caused by Squamous Cell Carcinoma. J Coll Physicians Surg Pak. 2018 Jun;28(6):S125-S127. doi: 10.29271/jcpsp.2018.06.S125. — View Citation

Aldelaimi TN, Khalil AA. Reconstruction of Facial Defect Using Deltopectoral Flap. J Craniofac Surg. 2015 Nov;26(8):e786-8. doi: 10.1097/SCS.0000000000002056. — View Citation

Beugels J, Cornelissen AJM, Spiegel AJ, Heuts EM, Piatkowski A, van der Hulst RRWJ, Tuinder SMH. Sensory recovery of the breast after innervated and non-innervated autologous breast reconstructions: A systematic review. J Plast Reconstr Aesthet Surg. 2017 — View Citation

Cao G, Zheng D, Sun F, Shou K. [RECONSTRUCTION OF AVULSED INJURIES OF HEEL WITH A SENSORY PREFABRICATED FLAP]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2015 Feb;29(2):198-201. Chinese. — View Citation

Ding J, Li Y, Li W, Liu C, Liu H, Cui J, Su Y, Ma X. Use of expanded deltopectoral skin flaps for facial reconstruction after sizeable benign tumor resections. Am J Transl Res. 2018 Jul 15;10(7):2158-2163. eCollection 2018. — View Citation

Ensat F, Greindl M, Skreiner A, Schubert H, Hladik M, Stuflesser A, Spies M, Wechselberger G. Colorimetric examination of typical free flap donor sites and comparison to recipient sites in the extremities. J Reconstr Microsurg. 2013 Jan;29(1):21-6. doi: 1 — View Citation

Germann G, Rudolf KD, Levin SL, Hrabowski M. Fingertip and Thumb Tip Wounds: Changing Algorithms for Sensation, Aesthetics, and Function. J Hand Surg Am. 2017 Apr;42(4):274-284. doi: 10.1016/j.jhsa.2017.01.022. Review. — View Citation

Hwang K. The Origins of Deltopectoral Flaps and the Pectoralis Major Myocutaneous Flap. J Craniofac Surg. 2016 Oct;27(7):1845-1848. Review. — View Citation

Ibrahim A, Atiyeh B, Karami R, Adelman DM, Papazian NJ. The Deltopectoral Flap Revisited: The Internal Mammary Artery Perforator Flap. J Craniofac Surg. 2016 Mar;27(2):e189-92. doi: 10.1097/SCS.0000000000002445. — View Citation

Kesting MR, MacIver C, Wales CJ, Wolff KD, Nobis CP, Rohleder NH. Surface-optimized free flaps for complex facial defects after skin cancer. J Craniomaxillofac Surg. 2015 Nov;43(9):1792-7. doi: 10.1016/j.jcms.2015.08.010. Epub 2015 Aug 20. — View Citation

Lu S, Chai Y. [Clinical application of sural fasciomyocutaneous perforator flap in repair of soft tissue defect in weight-bearing area of foot]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2014 Dec;28(12):1494-7. Chinese. — View Citation

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. — View Citation

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 Craniofa — View Citation

Moreno-Sánchez M, González-García R, Ruiz-Laza L, Manzano Solo de Zaldívar D, Moreno-García C, Monje F. Closure of the Radial Forearm Free Flap Donor Site Using the Combined Local Triangular Full-Thickness Skin Graft. J Oral Maxillofac Surg. 2016 Jan;74(1 — View Citation

Murono S, Ishikawa E, Nakanishi Y, Endo K, Kondo S, Wakisaka N, Yoshizaki T. Closure of tracheoesophageal fistula with prefabricated deltopectoral flap. Asian J Surg. 2016 Oct;39(4):243-6. doi: 10.1016/j.asjsur.2014.01.003. Epub 2014 Mar 25. — View Citation

Netscher D, Armenta AH, Meade RA, Alford EL. Sensory recovery of innervated and non-innervated radial forearm free flaps: functional implications. J Reconstr Microsurg. 2000 Apr;16(3):179-85. — View Citation

Okochi M, Okochi H, Sakaba T, Ueda K. The Reconstruction of the Donor Site of DP Flap Using Thoracodorsal Artery Perforator Flap. Plast Reconstr Surg Glob Open. 2017 Oct 23;5(10):e1521. doi: 10.1097/GOX.0000000000001521. eCollection 2017 Oct. — View Citation

Trevatt AE, Filobbos G, Ul Haq A, Khan U. Long-term sensation in the medial plantar flap: a two-centre study. Foot Ankle Surg. 2014 Sep;20(3):166-9. doi: 10.1016/j.fas.2014.03.001. Epub 2014 Mar 18. — View Citation

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(1 — View Citation

Yangqun L, Yong T, Wen C, Zhe Y, Muxin Z, Lisi X, Chunmei H, Yuanyuan L, Ning M, Jun F, Weixin W. [Reconstruction of facial soft tissue defects with pedicled expanded flaps]. Zhonghua Zheng Xing Wai Ke Za Zhi. 2014 Sep;30(5):326-9. Chinese. — View Citation

Zhao G, Wang B, Zhang W, Tang P, Chen C. Sensory reconstruction in different regions of the digits: A review of 151 cases. Injury. 2016 Oct;47(10):2269-2275. doi: 10.1016/j.injury.2016.07.035. Epub 2016 Jul 27. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

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