Lateral Arm Free Flap for Reconstruction of the Oral Cavity and Head and Neck Soft Tissue Defects.

• Sponsor: hassan harby mohamed (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05296811
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The excision of oral cancers causes extensive impairment of the oral cavity soft tissue. Complete excision of the tumors is vital, and the reconstruction of the resected area influences not only the postoperative recovery period of patients but also physiological functions such as swallowing, phonation function ,daily activities and psychosocial impact.

Oral and maxillofacial surgeons are faced with the task of reconstructing the affected area to reduce these problems as much as possible.

In 1982, Song introduced the lateral arm flap (LAF). Since this time, its used in surgical repairs of oral defects, But the specific subject of publications generally restricted to a small number of cases.

LAF is a thin and pliable flap with consistent anatomy and a high success rate. It is also claimed that there is no risk of vascular compromise to the arm

Condition or Disease	Intervention/Treatment	Phase
Oral Cancer	Procedure: Lateral Arm Free Flap	N/A

Detailed Description

reconstruction of oral , head and neck defects with Lateral Arm Free Flap

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Lateral Arm Free Flap for Reconstruction of the Oral Cavity and Head and Neck Soft Tissue Defects.
• Anticipated Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Outcome Measures

Primary Outcome Measures

1. Early detection of recurrence [3 month]

   reconstruction of defects in head and neck post surgical excision by lateral arm free flap and early detection of recurrence by CT neck.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. All patients post glossectomy.

2. Patients post maxillectomy with malignant maxillary swelling with no distant metastases.

3. All patients which defect after surgery for head and neck neoplasia.

Exclusion Criteria:

• 1. Small defect post excision can be closed directly 2. medically unfit patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University	Assiut		Egypt	71511

Sponsors and Collaborators

• hassan harby mohamed

Investigators

• Principal Investigator: hassan harby, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Nahabedian MY, Deune EG, Manson PN. Utility of the lateral arm flap in head and neck reconstruction. Ann Plast Surg. 2001 May;46(5):501-5.

• Responsible Party: hassan harby mohamed, principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT05296811
• Other Study ID Numbers: Lateral Arm Free Flap
• First Posted: Mar 25, 2022
• Last Update Posted: Mar 25, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Mouth Neoplasms

Study Results

No Results Posted as of Mar 25, 2022