Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03875833
Other study ID # HSC-DB-18-0760
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 9, 2020
Est. completion date January 1, 2024

Study information

Verified date May 2023
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether collagen nerve conduits placed on exposed radial and ulnar nerves during radial and ulnar forearm free flap harvests will reduce the occurrence and degree of sensory nerve deficit.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients present with a complex defect after tumor resection - all these cases done with the departments of Oral and Maxillofacial Surgery and Otolaryngology at the University of Texas in multiple locations that include, Memorial Hermann Hospital, Ben Taub General Hospital, Lyndon B. Johnson General Hospital and The Methodist hospital. - patients that have been diagnosed with head and neck tumors and who will undergo a composite resection and reconstruction with radial or ulnar free vascularized flap. Exclusion Criteria: - pre-existing nerve deficits - pregnant women

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Collagen Nerve Wrap Conduit
The collagen nerve wrap conduit will be placed on all exposed radial and ulnar nerves at the time of free flap harvest.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function baseline
Primary Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function 3 months
Primary Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function 6 months
Primary Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function 12 months
Primary Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported. baseline
Primary Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported. 3 months
Primary Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported. 6 months
Primary Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported. 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT05980598 - TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma Phase 2
Completed NCT02548377 - Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial N/A
Active, not recruiting NCT02229656 - Olaparib and Radiotherapy in Head and Neck Cancer Phase 1
Not yet recruiting NCT06347185 - Simultaneous Care in Recurrent and/or Metastatic Head and Neck Cancer: the SupCare Study N/A
Not yet recruiting NCT06289049 - Heavy Strength Training in Head and Neck Cancer Survivors Phase 2
Terminated NCT02975739 - Feasibility of Holmium-166 Micro Brachytherapy in Head and Neck Tumors N/A
Recruiting NCT00982436 - Neoadjuvant Cisplatin/Docetaxel (CDDP/TXT) and Chemoradiation for Head and Neck Cancer Phase 1/Phase 2
Completed NCT01025518 - DAHANCA 25A: Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients N/A
Active, not recruiting NCT00248235 - Resistance Exercise Training for the Shoulder and Neck Following Surgery for Head and Neck Cancer Phase 2/Phase 3
Terminated NCT00073450 - Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530) Phase 2
Completed NCT00135161 - Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer Phase 1
Not yet recruiting NCT06458517 - Evaluation of Two Methods of Administration of Photobiomodulation in the Context of the Prevention and Treatment of Mucositis Induced by Radiotherapy, During the Treatment of Head and Neck Cancers N/A
Completed NCT05269342 - Nurse-led Exercise Improves Shoulder Pain, Shoulder Disability, and Quality of Life in Head and Neck Cancer N/A
Recruiting NCT05544136 - A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer Phase 2
Terminated NCT03286972 - PET/MRI to Enhance Precision Guidance in Head and Neck Radiation Treatment Planning
Recruiting NCT04435938 - A Study of SBRT for Squamous Cell Carcinoma of the Head and Neck Phase 2
Recruiting NCT03678649 - A Prospective Randomized Trial of Capecitabine Treatment in Patients With HNSCC Phase 2
Recruiting NCT03975465 - EMST and Swallowing in Long-Term Survivors of HNCA N/A
Completed NCT03292250 - Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)] Phase 2
Completed NCT06446570 - Phase II Study of Durvalumab(MEDI4736) + Tremelimumab in Pulmonary Sarcomatoid Carcinoma Phase 2