Comparing Two Skin Incisions for Flexor Tendon Repair
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSahlgrenska University Hospital
About this trial
Flexor tendons injuries in the fingers are common and often require surgery. During surgery, the surgeon needs to make an incision in the skin on the inside of the finger to access the damaged tendon.
A comparison will be done between two types of skin incisions in the fingers:
* Bruner zig-zag incision * modified Bruner midlateral zig-zag incision
Research questions:
* Is there a difference in pain between the types of incisions? * Is there a difference in swelling between the types of incisions? * Does the type of incision affect the final result in term of motion?
Patients who will undergo surgery for a flexor tendon injury in a finger will be asked to participate and be randomized to one type of skin incision. All other parts of the surgery will be carried out as usual.
An occupational therapist and nurse will measure swelling and motion. The participant will report pain on a daily basis.
The results for pain, swelling, motion in the fingers and sensibility in the fingers will be statistically compared between the two types of incisions on a group level.
The results of this study may lead to guidelines for skin incisions in acute flexor tendon repair, allowing patients to experience less pain and swelling. This may facilitate the rehabilitation program and improve the final functional outcome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
flexor tendon injury in the hand in zone 2
Disqualifiers
complex injuries with fracture and/or skin defect
previous injury with functional deficit of the finger or the contralateral control finger
incapable to follow the training protocol for flexor tendon injuries
not proficient in swedish or english language
Trial design
Design model
Parallel
Treatments tested in this trial
Skin incision for flexor tendon repair
Procedure/SurgeryTwo different types of skin incisions will be compared for patients needing flexor tendon repair in the finger.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: BrunerActive comparator 1 intervention
Group B: Modified BrunerActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
pain with exercise
Visual Analogue scale from 0 to 10. 0 = is no pain at all; 10 = the worst pain
Time frame
from day 3 after surgery, daily until 3 months after surgerySecondary outcomes
1
pain at rest
Visual Analogue Scale from 0 to 10. 0 = no pain at all; 10 = the worst pain
Time frame
from day 3 after surgery until 3 months after surgery2
pain medication
use of pain medication, opioids/non-opioids
Time frame
from day 3 after surgery until 3 months after surgery3
swelling
fingers circumferens in mm
Time frame
at 2, 4, 6, 8, 12 weeks4
range of motion
total active motion of the finger
Time frame
at 2, 4, 6, 8, 12 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sahlgrenska University Hospital
Lead sponsor
Västra Götalandsregionen
Collaborator
Göteborg University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: