AzTrials
AzTrials

Flexor Tendon InjuryNCT07596017

Comparing Two Skin Incisions for Flexor Tendon Repair

A study testing Skin incision for flexor tendon repair in people with Flexor Tendon Injury and Incision, Surgical, run by Sahlgrenska University Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Flexor Tendon Injury, Incision, Surgical
What is being tested?
Skin incision for flexor tendon repair
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
No sites listed yet
Study dates
1 Jun 2026to 1 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • flexor tendon injury in the hand in zone 2

Who cannot join

  • 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
  • active substance abuse

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Katleen Libberecht, MD contact

+46 731471269

katleen.libberecht@vgregion.se

Lena Shafie, MSc contact

lena.shafie@vgregion.se

About this study

Official title: Prospective Randomized Controlled Trial to Compare Bruner Incision With Modified Midlateral Bruner Incision for Flexor Tendon Repair

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:

Read more
  • 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.

Read the detailed description

Background and Purpose Tendon injuries are a common type of hand trauma, with flexor tendon injuries most often occurring in zone II. Careful surgical technique followed by early, intensive mobilization under the supervision of a hand therapist is of utmost importance. The traditional Bruner incision, a zig-zag incision, provides wide exposure. However, it also causes extensive soft tissue trauma, leading to swelling and pain, which in turn may reduce adherence to hand rehabilitation protocols. The modified Bruner incision is an alternative approach in which the incision is placed along the lateral side of the finger and slightly curved volarly toward the midpoint between the flexion creases, without crossing the volar midline. This approach provides adequate exposure of the flexor tendon and the digital neurovascular structures with less dissection. Clinical experience suggests that the modified Bruner incision may result in less swelling and pain, faster wound healing and improved conditions for early mobilization. However, there is currently a lack of studies comparing clinical outcomes between the traditional Bruner incision and the modified Bruner incision.

The aim of this study is to investigate whether there are differences in swelling, pain and functional outcomes between patients undergoing flexor tendon repair using the traditional Bruner incision versus the modified Bruner incision.

Research Questions

In primary repair of zone II flexor tendon injuries:

  1. Do patients treated with a modified Bruner incision experience less postoperative pain during the first three months after surgery?
  2. Do fingers operated on using a modified Bruner incision demonstrate reduced swelling during the first three postoperative months?
  3. Do fingers repaired with a modified Bruner incision show improved range of motion during the first three postoperative months?

Methods A randomized controlled study conducted at the Department of Hand Surgery, Mölndal Hospital.

Eligible patients with acute flexor tendon injuries will be invited to participate. After providing informed consent, participants will be randomised to undergo either a standard Bruner incision or a modified midlateral Bruner incision, with all other operative and perioperative variables standardised between the groups.

All procedures will be performed by either a specialist in hand surgery or a hand surgery resident. Within three days postoperatively, at the first dressing change, patients will be assessed by an occupational therapist.

Follow-up evaluations will be conducted at fixed time points: 2, 4, 6, 8, and 12 weeks after surgery. Wound healing will be monitored weekly by a nurse until complete healing has been achieved.

Outcome Measures

Primary outcome

  • Pain during exercise, measured using the Visual Analogue Scale (VAS) 0-10; assessed on postoperative day 3 and thereafter daily for 3 months postoperatively (REDCap questionnaire) Secondary outcomes
  • Resting pain
  • Daily use of analgesics (REDCap questionnaire)
  • Swelling: circumference of the injured finger / circumference of the contralateral finger (OT)
  • Range of motion: Total Passive Motion (TPM) and Total Active Motion (TAM) of the injured finger / TPM and TAM of the contralateral finger (OT)
  • Fingertip sensibility: Semmes-Weinstein monofilament testing (OT), two-point discrimination (physician)
  • Extension deficit of the proximal and distal interphalangeal joints (PIP and DIP) (OT)
  • Wound healing: Surgical Wound Assessment Tool (SWAT) (nurse)
  • Length of the skin incision (cm); a photograph of the incision pattern is obtained intraoperatively

Independent Variables

  • Sex
  • Age
  • Systemic disease: diabetes mellitus, vascular disease, chronic obstructive pulmonary disease (COPD)
  • Occupation
  • Occupational injury Yes/No
  • Mechanism of injury
  • Number of injured fingers
  • Digital nerve injury
  • Type of anesthesia
  • Type of suture
  • Type of rehabiliation protocol
  • Complications: wound infection, suture rupture, conversion of incision

Data Sources Data will be recorded in eCRF using REDCap. Patients will report daily, at predefined time points, VAS pain scores and number of analgesic tablets taken the same day through mobile-based questionaries.

Statistical Analysis The primary outcome measure is pain during exercise, where a between-group difference of 2 points is considered clinically relevant. Assuming a significance level of p < 0.05 and an estimated standard deviation of 2.5 points, the required sample size is calculated to be 26 patients per group to achieve 80% power. To compensate for potential dropouts, a total of 70 patients will be included (35 in each group). Differences in pain, swelling and range of motion at different time points will be compared using bivariate analyses.

Ethics Participation in the study does not involve any change in standard care, except for the surgical incision, which differs between two established methods, the Bruner incision and the modified Bruner incision. Both incision types are standard treatments and have been in clinical use for many years. All patients will receive oral and written information and provide informed consent before inclusion. Participation is voluntary and may be discontinued at any time without affecting the patient's care. Collected data will be pseudonymized and stored securely in locked storage.

Clinical Benefit The results of this study may lead to evidence-based guidelines for skin incisions in acute flexor tendon repair, allowing patients to experience less pain and swelling. This may facilitate the postoperative rehabilitation program and improve the final functional outcome.

Being tested
Skin incision for flexor tendon repair
Keywords
incision, Bruner, midlateral incision, flexor tendon, modified Bruner
Medical subject headings
Surgical Wound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Skin incision for flexor tendon repairProcedure or surgery

    Two different types of skin incisions will be compared for patients needing flexor tendon repair in the finger.

Study groups in NCT07596017
Study groupRoleWhat they receive
BrunerActive comparatorTraditional Bruner skin incision
Receives: Procedure: Skin incision for flexor tendon repair
Modified BrunerActive comparatorModified midlateral Bruner skin incision
Receives: Procedure: Skin incision for flexor tendon repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain with exercise

    Visual Analogue scale from 0 to 10. 0 = is no pain at all; 10 = the worst pain

    Measured: from day 3 after surgery, daily until 3 months after surgery

Secondary outcomes (9)
  1. pain at rest

    Visual Analogue Scale from 0 to 10. 0 = no pain at all; 10 = the worst pain

    Measured: from day 3 after surgery until 3 months after surgery

  2. pain medication

    use of pain medication, opioids/non-opioids

    Measured: from day 3 after surgery until 3 months after surgery

  3. swelling

    fingers circumferens in mm

    Measured: at 2, 4, 6, 8, 12 weeks

  4. range of motion

    total active motion of the finger

    Measured: at 2, 4, 6, 8, 12 weeks

  5. sensation SW

    Semmes-Weinstein in the fingertip

    Measured: at 8 weeks

  6. sensation 2PD

    two-point discrimination in the fingertip

    Measured: at 8 weeks

  7. extension lag

    extension lag in the PIP and DIP

    Measured: at 2, 4, 6, 8, 12 weeks

  8. skin healing

    Healing scored according to the Surgical Wound Assessment Tool leading to a score between 0 and 39. 0 = the best score and 39 the worst.

    Measured: at 2, 3, 4, weeks

  9. length of incision

    length of incision in cm

    Measured: at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07596017
Sponsor's protocol ID
Dnr 2026-00708-01
Status last verified
May 2026
First submitted
12 May 2026
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: I don't see why this would be necessary and it is probably not allowed by my ethical authority.

Questions about this trial

What is this clinical trial studying?

A study testing Skin incision for flexor tendon repair in people with Flexor Tendon Injury and Incision, Surgical, run by Sahlgrenska University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Katleen Libberecht, MD (+46 731471269, katleen.libberecht@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain with exercise (time frame: from day 3 after surgery, daily until 3 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in