search
Back to results

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

Primary Purpose

Head Neck Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Recipient vessel selected for microanastomosis
Sponsored by
Instituto Nacional de Cancer, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head Neck Neoplasms focused on measuring microanastomosis, free tissue flaps, cervical vessels, superficial temporal vessels, advanced reconstruction

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Brazilian National Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Superficial temporal recipient vessels (group A)

Cervical recipient vessels (group B)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 18, 2023
Last Updated
March 3, 2023
Sponsor
Instituto Nacional de Cancer, Brazil
search

1. Study Identification

Unique Protocol Identification Number
NCT05749120
Brief Title
Recipient Vessels for Free Tissue Flaps in Advanced Oncologic Defects of the Midface and Scalp
Official Title
Recipient Vessels for Free Tissue Flaps in Advanced Oncologic Defects of the Midface and Scalp: Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cancer, Brazil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Advanced oncologic defects of the midface and scalp are a significant challenge to the reconstructive head neck surgeon, who must consider the need for midfacial projection, rehabilitation, and function restoration. Free flaps reconstruction in the midface and scalp region are the gold standard for advanced cases. There is no consensus in the literature on which recipient vessel is most suitable for performing microanastomosis using free flaps for advanced midface and scalp oncologic defect. The aim of this clinical trial is prospectively compare the results of microvascular flap reconstruction of midface and scalp advanced oncologic defects using superficial temporal versus cervical as recipient vessels. This is a parallel trial with permuted block randomization of patients who will be undergone a midface and scalp oncologic reconstruction with free tissue flap. Two groups will be analyzed: 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). Allocation ratio will de 1:1 participants. Patient gender and age, cause and localization of the defect, flap choice for reconstruction, recipient vessels, intraoperative outcome, postoperative course, and complications were recorded and analyzed. Considering that this is a disease with rare staging, the calculated sample size was 26, but it will be increased by 30% (total of 34 participants who will be selected) since the death rate of these patients ranges from 8-25% A Fisher's exact test will be used to compare outcomes between the 2 groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Neck Neoplasms
Keywords
microanastomosis, free tissue flaps, cervical vessels, superficial temporal vessels, advanced reconstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel group trial design with allocation ratio of 1:1 and permuted block randomization
Masking
Participant
Masking Description
The care provider knows the surgical intervention and the randomized participant doesn´t know the recipient vessel performed
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Superficial temporal recipient vessels (group A)
Arm Type
Experimental
Arm Description
Participants in whom superficial temporal vessels were used as the recipient vessels.
Arm Title
Cervical recipient vessels (group B)
Arm Type
Active Comparator
Arm Description
Participants in whom cervical vessels were used as the recipient vessels.
Intervention Type
Procedure
Intervention Name(s)
Recipient vessel selected for microanastomosis
Intervention Description
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.
Primary Outcome Measure Information:
Title
To compare the overall flap survival rate after the microanastomosis
Description
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.
Time Frame
Participants were assessed twice a day for the first 10 days after the intervention and then weekly for 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno A Sousa, MD
Organizational Affiliation
Brazilian National Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brazilian National Cancer Institute
City
Rio De Janeiro
ZIP/Postal Code
20230130
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35864586
Citation
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.
Results Reference
result
PubMed Identifier
35213928
Citation
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.
Results Reference
result
PubMed Identifier
31347733
Citation
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.
Results Reference
result
PubMed Identifier
35710778
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs