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Comparing Two Skin Incisions for Flexor Tendon Repair

2026年5月19日 更新者:Anders Bjorkman、Sahlgrenska University Hospital

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:

  • 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.

調査の概要

状態

まだ募集していません

詳細な説明

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.

研究の種類

介入

入学 (推定)

70

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • flexor tendon injury in the hand in zone 2

Exclusion Criteria:

  • 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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:Bruner
Traditional Bruner skin incision
Two different types of skin incisions will be compared for patients needing flexor tendon repair in the finger.
アクティブコンパレータ:Modified Bruner
Modified midlateral Bruner skin incision
Two different types of skin incisions will be compared for patients needing flexor tendon repair in the finger.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
pain with exercise
時間枠:from day 3 after surgery, daily until 3 months after surgery
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

二次結果の測定

結果測定
メジャーの説明
時間枠
pain medication
時間枠:from day 3 after surgery until 3 months after surgery
use of pain medication, opioids/non-opioids
from day 3 after surgery until 3 months after surgery
swelling
時間枠:at 2, 4, 6, 8, 12 weeks
fingers circumferens in mm
at 2, 4, 6, 8, 12 weeks
range of motion
時間枠:at 2, 4, 6, 8, 12 weeks
total active motion of the finger
at 2, 4, 6, 8, 12 weeks
sensation SW
時間枠:at 8 weeks
Semmes-Weinstein in the fingertip
at 8 weeks
sensation 2PD
時間枠:at 8 weeks
two-point discrimination in the fingertip
at 8 weeks
extension lag
時間枠:at 2, 4, 6, 8, 12 weeks
extension lag in the PIP and DIP
at 2, 4, 6, 8, 12 weeks
length of incision
時間枠:at 3 months
length of incision in cm
at 3 months
pain at rest
時間枠:from day 3 after surgery until 3 months after surgery
Visual Analogue Scale from 0 to 10. 0 = no pain at all; 10 = the worst pain
from day 3 after surgery until 3 months after surgery
skin healing
時間枠:at 2, 3, 4, weeks
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.
at 2, 3, 4, weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Anders Björkman, MD, PhD、Göteborg University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2028年6月1日

研究の完了 (推定)

2028年6月1日

試験登録日

最初に提出

2026年5月12日

QC基準を満たした最初の提出物

2026年5月12日

最初の投稿 (実際)

2026年5月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月22日

QC基準を満たした最後の更新が送信されました

2026年5月19日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • Dnr 2026-00708-01

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

I don't see why this would be necessary and it is probably not allowed by my ethical authority.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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