An interventional study of Collagen Nerve Wrap Conduit in Head and Neck Neoplasms and Dysesthesia, sponsored by The University of Texas Health Science Center, Houston. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-22.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
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.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
Browse Head and Neck Neoplasms studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
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Exclusion Criteria:
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.
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
Time frame: baseline
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
Time frame: 3 months
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
Time frame: 6 months
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
Time frame: 12 months
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.
Time frame: baseline
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.
Time frame: 3 months
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.
Time frame: 6 months
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.
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston →