NCT07596017

Brief 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. 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Jun 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 12, 2026

Last Update Submit

May 19, 2026

Conditions

Flexor Tendon InjuryIncision, Surgical

Keywords

incisionBrunermidlateral incisionflexor tendonmodified Bruner

Outcome Measures

Primary Outcomes (1)

  • pain with exercise

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

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

Secondary Outcomes (9)

  • pain at rest

    from day 3 after surgery until 3 months after surgery

  • pain medication

    from day 3 after surgery until 3 months after surgery

  • swelling

    at 2, 4, 6, 8, 12 weeks

  • range of motion

    at 2, 4, 6, 8, 12 weeks

  • sensation SW

    at 8 weeks

  • +4 more secondary outcomes

Study Arms (2)

Bruner

ACTIVE COMPARATOR

Traditional Bruner skin incision

Procedure: Skin incision for flexor tendon repair

Modified Bruner

ACTIVE COMPARATOR

Modified midlateral Bruner skin incision

Procedure: Skin incision for flexor tendon repair

Interventions

Skin incision for flexor tendon repairPROCEDURE

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

BrunerModified Bruner

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • flexor tendon injury in the hand in zone 2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Anders Björkman, MD, PhD

    Göteborg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katleen Libberecht, MD

CONTACT

+46 731471269katleen.libberecht@vgregion.se

Lena Shafie, MSc

CONTACT

lena.shafie@vgregion.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Hand Surgery

Study Record Dates

First Submitted

May 12, 2026

First Posted

May 19, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

May 22, 2026

Record last verified: 2026-05