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

March 3, 2023 updated by: Bruno Albuquerque, MD, Instituto Nacional de Cancer, Brazil

Recipient Vessels for Free Tissue Flaps in Advanced Oncologic Defects of the Midface and Scalp: Prospective Randomized Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio De Janeiro, Brazil, 20230130
        • Brazilian National Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Superficial temporal recipient vessels (group A)
Participants in whom superficial temporal vessels were used as the recipient vessels.
Procedure: Recipient vessel selected for microanastomosis
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.
Active Comparator: Cervical recipient vessels (group B)
Participants in whom cervical vessels were used as the recipient vessels.
Procedure: Recipient vessel selected for microanastomosis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the overall flap survival rate after the microanastomosis
Time Frame: Participants were assessed twice a day for the first 10 days after the intervention and then weekly for 4 weeks.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancer, Brazil

Investigators

  • Principal Investigator: Bruno A Sousa, MD, Brazilian National Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

February 18, 2023

First Submitted That Met QC Criteria

February 18, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 89042418.7.0000.5274

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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