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

Sponsor

Instituto Nacional de Cancer, Brazil (Other)

Overall Status

Completed

CT.gov ID

NCT05749120

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Head Neck Neoplasms	Procedure: Recipient vessel selected for microanastomosis	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Participant)

Masking Description:

The care provider knows the surgical intervention and the randomized participant doesn´t know the recipient vessel performed

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2018

Actual Primary Completion Date :

Apr 30, 2022

Actual Study Completion Date :

Jun 30, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

To compare the overall flap survival rate after the microanastomosis [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts 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