The Reliability and Versatility of Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of Lip Defects

NCT ID: NCT04974918

Last Updated: 2021-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-30
• Study Completion Date: 2022-12-30

Brief Summary

Nasolabial flaps have limited mobility and may need two stages, mostly for intraoral defects .The facial artery perforator-based flap is the first true perforator flap in the face. It allows one-stage reconstruction and allows freedom in flap design.

The nasolabial perforator flap has certain advantages such as repair using a similar tissue, a wider rotation arc around the pedicle compared to the other regional flaps, and the primary closure of the donor area.

Detailed Description

Recently, perforator flaps have become popular in many areas of reconstructive surgery. They provide design freedom and reduce donor-site morbidity. Many traditional local flaps including nasolabial flaps are based on the use of the axial facial artery with multiple perforators. Flaps based on one perforator of the facial artery have been introduced and are used more frequently because of their advantages over perforator flaps.

According to recent literatures, facial artery provides numerous cutaneous perforators, on which skin flaps can be islanded, with greater mobility and liability for reconstruction of small-to-moderate-sized intraoral and facial defects in one stage. .

Multiple perforators along the facial artery, a mean of 4 on each half of the face (range: 2-8), with a mean diameter of 0.94 mm (range: 0.53-1.36 mm) and maximum perforators between 20 and 60 mm from the origin along the length of the facial artery. This roughly corresponds to an area near the angle of the mouth around the nasolabial fold. A local skin flap based on such perforators can be islanded, with greater freedom in flap designing for reconstruction of small-to-moderate-sized intraoral and facial defects in one stage Ethical consideration This study will be approved by the ethics committee of Faculty of Medicine Sohag University. A written informed consent will be taken from every patient that will be included in this study and all patients will be informed about the nature & the aim of the study and the possibility of any complication.

Surgical technique:

After tumor ablation the facial artery perforator along the nasolabial fold was found and marked with a handheld Doppler probe. A perforator near the defect was selected to accomplish a sufficient arc of rotation without tension. The flap was designed to cover the defect based on one perforator and to hide the donor site in the nasolabial fold. An incision on one side of the flap was made to the subcutaneous tissue. Undermining of the flap until the perforators were identified. After the perforators were identified, the flap was redesigned and an incision was made circumferentially. Dissection of the pedicle was performed until tension-free transposition was done to cover the defect, and the distal perforators were sacrificed to help flap movement. For protection against shear forces, the investigators left a small cuff of subcutaneous fat around the perforator

Conditions

Lip Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of Lip defects

participants will be chosen according to liable age and information will be given about complications

Group Type: EXPERIMENTAL

Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of large Lip defects post traumatic or post tumor resection.

Intervention Type: PROCEDURE

A perforator near the defect was selected to accomplish a sufficient arc of rotation without tension. The flap was designed to cover the defect based on one perforator and to hide the donor site in the nasolabial fold. An incision on one side of the flap was made to the subcutaneous tissue. Undermining of the flap until the perforators were identified. After the perforators were identified, the flap was redesigned and an incision was made circumferentially. Dissection of the pedicle was performed until tension-free transposition was done to cover the defect, and the distal perforators were sacrificed to help flap movement.

Interventions

Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of large Lip defects post traumatic or post tumor resection.

A perforator near the defect was selected to accomplish a sufficient arc of rotation without tension. The flap was designed to cover the defect based on one perforator and to hide the donor site in the nasolabial fold. An incision on one side of the flap was made to the subcutaneous tissue. Undermining of the flap until the perforators were identified. After the perforators were identified, the flap was redesigned and an incision was made circumferentially. Dissection of the pedicle was performed until tension-free transposition was done to cover the defect, and the distal perforators were sacrificed to help flap movement.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Lip defect more than half of lip
• Patients aging 7 to 70 years

Exclusion Criteria

• Lip defect less than half of lip
• Patients with a major uncontrollable medical illness, chronic heavy smokers

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Aya Ahmed Ahmed

resident doctor at plastic surgery sohag university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gamal Yossef Elsayed, MD

Role: STUDY_CHAIR

sohag university , Egypt

Central Contacts

Aya Ahmed Ahmed, resident

Role: CONTACT

aya.abdelmawgod@med.sohag.edu.eg

01125473647

Ahmed Gaber Ahmed, MD

Role: CONTACT

01062580587

References

Ercan A, Ercan LD, Demiroz A. Nasolabial Perforator Flap: A Multi-Tool for Reconstruction of Facial Units. J Craniofac Surg. 2020 Jun;31(4):1042-1045. doi: 10.1097/SCS.0000000000006285.

Reference Type: RESULT

PMID: 32168126 (View on PubMed)

Other Identifiers

Soh-Med-21-07-07

Identifier Type: -

Identifier Source: org_study_id