Recipient Vessels for Free Tissue Flaps in Advanced Oncologic Defects of the Midface and Scalp

NCT05749120 | Completed DMC

• 1 other identifier: 89042418.7.0000.5274
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the postoperative outcomes based on superficial temporal versus cervical recipient vessels for midface and scalp advanced oncologic defects using free tissue flap for reconstruction. The main question it aims to answer is: • Which recipient vessel is most suitable for performing microanastomosis using free flaps for advanced midface and scalp oncologic defect. Participants will be undergo resection of advanced malignant tumors of the midface and scalp with subsequent oncological reconstruction using free tissue flap. Researchers will compare two groups where those in whom superficial temporal vessels will be used as the recipient vessels (group A) and those in whom cervical vessels will be used as the recipient vessels (group B) to see if there is a recipient vessel who is most suitable for performing microanastomosis using free flaps for advanced midface and scalp oncologic defect.

Conditions

Head Neck Neoplasms

Keywords

microanastomosis; free tissue flaps; cervical vessels; superficial temporal vessels; advanced reconstruction

Outcome Measures

Primary Outcomes (1)

• To compare the overall flap survival rate after the microanastomosis

  Adequate perfusion of the free tissue flap was assessed using Doppler flowmetry, flap bleeding time after puncture, color, texture and turgor. Both venous and arterial thrombosis were evaluated by these methods in order to detect whether there was any evidence of low or absence of vascular perfusion of the flap.

  Participants were assessed twice a day for the first 10 days after the intervention and then weekly for 4 weeks.

Study Arms (2)

Superficial temporal recipient vessels (group A)

EXPERIMENTAL

Participants in whom superficial temporal vessels were used as the recipient vessels.

Procedure: Recipient vessel selected for microanastomosis

Cervical recipient vessels (group B)

ACTIVE COMPARATOR

Participants in whom cervical vessels were used as the recipient vessels.

Procedure: Recipient vessel selected for microanastomosis

Interventions

Recipient vessel selected for microanastomosis PROCEDURE

Free tissue flaps harvesting and microanastomosis were performed by the same surgeon and in a similar way in both group. Postoperative course, and complications were recorded and analyzed.

Cervical recipient vessels (group B); Superficial temporal recipient vessels (group A)

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients submitted to subtotal, total, or extensive radical oncologic maxillectomy, or advanced scalp oncologic defect
• Complete medical records for at least 30 days after the intervention
• Patients eligible for microanastomosis in both cervical and superficial temporal recipient vessels

You may not qualify if:

• Pregnancy or breastfeeding;
• Serious diseases (sepsis, renal and hepatic failure, severe cardiovascular diseases, chronic obstructive pulmonary disease);
• Patients with HIV (human immunodeficiency virus) with or without AIDS (acquired immunodeficiency syndrome);
• Patients with synchronous malignant neoplasms of the upper airway-digestive tract;
• Patients who died within a period of less than 30 days or who were lost to follow-up for the same period

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

Study Sites (1)

Brazilian National Cancer Institute

Rio de Janeiro, 20230130, Brazil

Location

Related Publications (4)

• Awwad L, Obed D, Vogt PM, Kaltenborn A, Koenneker S. Superficial Temporal Recipient Vessels for Craniofacial Microvascular Free-Flaps. J Craniofac Surg. 2022 Sep 1;33(6):e652-e657. doi: 10.1097/SCS.0000000000008768. Epub 2022 Jul 22.

  PMID: 35864586 RESULT

• Mata Ribeiro L, Tsao CK, Hung YL, Chu CH, Lin LC, Lin MH, Peng C, Cheong DC, Hung SY, Liao CT. Venous Size Discrepancy Is a Critical Factor When Using Superficial Temporal Vessels as Recipient Vessels for Free Flaps. J Reconstr Microsurg. 2022 Oct;38(8):654-663. doi: 10.1055/s-0042-1743165. Epub 2022 Feb 25.

  PMID: 35213928 RESULT

• Sudirman SR, Shih HS, Chen JC, Feng KM, Jeng SF. Superficial temporal vessels, both anterograde and retrograde limbs, are viable recipient vessels for recurrent head and neck reconstruction in patients with frozen neck. Head Neck. 2019 Oct;41(10):3618-3623. doi: 10.1002/hed.25886. Epub 2019 Jul 26.

  PMID: 31347733 RESULT

• Mattine S, Payne KFB. The evolving role of the superficial temporal vessels as anastomotic recipients in challenging microvascular reconstruction of the upper two-thirds of the face. J Plast Reconstr Aesthet Surg. 2022 Sep;75(9):3330-3339. doi: 10.1016/j.bjps.2022.04.089. Epub 2022 May 2.

  PMID: 35710778 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Bruno A Sousa, MD

  Brazilian National Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The care provider knows the surgical intervention and the randomized participant doesn´t know the recipient vessel performed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Parallel group trial design with allocation ratio of 1:1 and permuted block randomization

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: March 1, 2023
• Study Start: April 1, 2018
• Primary Completion: April 30, 2022
• Study Completion: June 30, 2022
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)