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Surgical FlapsNCT03735641

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

An observational study of Surgical Flaps and Skin Pigmentation, run by Xijing Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 14 to 55 years
Conditions the study is for
Surgical Flaps, Skin Pigmentation, Sensory Defect
What is being tested?
Expanded Pedicled Deltopectoral Flap
Type of treatment
Surgery or procedure
How many people
50 participants
Where
1 siteChina
Study dates
1 Oct 2018to Nov 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 55 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital, the Air Force Medical University

    Xi'an, Shaanxi, 710000

Other trials in China

About this study

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

Read the 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.

Being tested
Expanded Pedicled Deltopectoral Flap
Keywords
Expanded Pedicled Deltopectoral Flap, skin color, Sensory recovery
Medical subject headings
Pigmentation Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Expanded Pedicled Deltopectoral FlapProcedure or surgery

    Expanded Pedicled Deltopectoral Flap is a type of surgical flap

Study groups in NCT03735641
Study groupRoleWhat they receive
postoperativeExpanded 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
Receives: Procedure: Expanded Pedicled Deltopectoral Flap

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 3 month later

Secondary outcomes (8)

  1. Temperature

    Test tubes were equilibrated in water at 0◦C (cold) or 45-50 ◦C (warm) and applied for 5 s.

    Measured: 3 month later

  2. 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.

    Measured: 3 month later

  3. 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.

    Measured: 3 month later

  4. 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.

    Measured: 3 month later

  5. 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.

    Measured: 3 month later

  6. 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.

    Measured: 3 month later

  7. Satisfaction questionnaire

    At least 3 months after the patient's surgery, use a self-made satisfaction questionnaire to obtain patient satisfaction

    Measured: 3 month later

  8. 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.

    Measured: 6 month later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2018
  2. Study start1 Oct 2018
  3. Primary completionOct 2019 (estimated)
  4. Study completionNov 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03735641
Sponsor's protocol ID
KY20182035-C-1
Status last verified
Sep 2018
First submitted
17 Oct 2018
Last updated
8 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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: 10.1055/s-0032-1326734. Epub 2012 Oct 23.

    PubMed 23093467

  • 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. doi: 10.1055/s-2000-7549.

    PubMed 10803620

  • 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.

    PubMed 28749842

  • 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.

    PubMed 28708657

  • 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.

    PubMed 29866245

  • 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.

    PubMed 30093952

  • 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.

    PubMed 29184736

  • Hwang K. The Origins of Deltopectoral Flaps and the Pectoralis Major Myocutaneous Flap. J Craniofac Surg. 2016 Oct;27(7):1845-1848. doi: 10.1097/SCS.0000000000003057.

    PubMed 27763977

  • 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.

    PubMed 26854779

  • 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.

    PubMed 24674898

  • 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.

    PubMed 26595007

  • Moreno-Sanchez M, Gonzalez-Garcia R, Ruiz-Laza L, Manzano Solo de Zaldivar D, Moreno-Garcia 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):204-11. doi: 10.1016/j.joms.2015.08.003. Epub 2015 Aug 7.

    PubMed 26342949

  • 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.

    PubMed 26355025

  • 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.

    PubMed 25522480

  • 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 Sep;70(9):1229-1241. doi: 10.1016/j.bjps.2017.05.001. Epub 2017 May 24.

    PubMed 28687258

Questions about this trial

What is this clinical trial studying?

An observational study of Surgical Flaps and Skin Pigmentation, run by Xijing Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Flap Color（the value of L*a*b*） (time frame: 3 month later). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03735641, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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