Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01573650 |
| Other study ID # |
Version 2, 01/04/2012 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2015 |
| Est. completion date |
July 7, 2021 |
Study information
| Verified date |
November 2021 |
| Source |
University Hospital, Basel, Switzerland |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
1. To analyse the outcome of different treatment options of peripheral nerve repair with no
gap (group 1) and with a critical sized (>5mm) defect (group 2) in order to optimize
peripheral nerve repair
2. To reduce morbidity with the same outcome
Description:
Patients planned to undergo peripheral nerve repair after traumatic nerve injury with either
no gap (group 1) or with a critical sized defect (>5mm, group 2) of the finger providing
written informed consent to this investigation will be randomised in two groups:.
Group 1: nerve repair with no gap Group 1a (standard): Epineural Suture Group 1b
(experimental): Epineural Suture and Fibrin Wrap Group 2: Nerve repair with a critical sized
(>5mm) defect Group 2a (standard): Epineural suture and autologous nerve transplantation from
lateral antebrachial cutaneous nerve (LACN) Group 2b (experimental): Epineural suture and
Fibrin Conduit
In all groups an epineural suture will be performed (suture enhancement). The outcome of
fibrin enwrapment and fibrin conduit will be compared to the standard treatment option to
date (direct nerve repair and autologous nerve graft, respectively). Randomization will be
performed using a computer-base algorithm (www.randomizer.at). Ambulatory follow up of
patients is carried out by the Department of Plastic, Reconstructive and Aesthetic Surgery,
Handsurgery, University Hospital Basel. The outcome-assessor as well as the patient will be
blinded for analysis and the outcome-assessor will have no access to the surgery report.
The investigator's aim is to analyse 48 patients within 12 months. Since 100 patients undergo
peripheral nerve repair annually in the Department of Plastic, Reconstructive and Aesthetic
Surgery, Handsurgery at the University Hospital Basel, patient accrual appears unproblematic.
After completion, statistical analysis focusing on the comparison of the different types of
surgery concerning the clinical parameters 2-Point Discrimination (PD), Semmes Weinstein
test, and electroneurography will be conducted.
After six months, no difference will be expected between group 1a and 1b or 2a and 2b,
respectively. In the investigator's experience there will be no confounders which may
influence nerve regeneration. A similar patient satisfaction will be expected between the
groups. The investigator expect a higher patient satisfaction in group 2b than in group 2a
due to nerve tissue harvest. Between group 1a and 1b no difference is expected regarding MHQ.
