Cosmetic Outcome at 4 Months in Hand and Feet Lacerations in Children: Conservative Versus Suture Repair
2020年9月16日 更新者：Trevor Tredway, MD、St. Louis University
Conservative Versus Suture Repair of Hand and Feet Lacerations in Children
Hand and feet lacerations are common in children with repair often requiring conscious sedation and needle sticks for repair.
Growing evidence in adults reveal that many of these small lacerations do quite well cosmetically without intervention.
This randomized controlled trial will evaluated the cosmetic outcome at 4 months in two groups of children with hand or feet lacerations <2 cm comparing suturing vs conservative wound management.
調査の概要
詳細な説明
The purpose of this study is to compare outcomes of 2 repair methods in simple (<2cm) hand and feet lacerations in the pediatric population (2-17 yrs).
Our hypothesis is that there is no statistical difference in cosmetic outcomes between suture repair and non-repair of these injuries.
This study has been performed in the adult population, but has not yet been done in children.
The researchers would like to be the first to show that conservative repair can be done in our pediatric population.
The suture group will have their injuries repaired with non-absorbable sutures (nylon) which remain the gold standard in cosmetic repair of hands and feet.
The conservative group will have identical cleaning and preparation of the wound, but the laceration will be covered with antibiotic ointment and sterile gauze without repair.
Secondary outcome measure include patient satisfaction, infection rates, pain during repair, time of initial ED visit stay, and cost of supplies used in repair.
Our patients will return in 10 -14 days for follow up and in 4 months for evaluation of the wound and for digital pictures to be taken of the wound.
Wounds and scars will be evaluated at both 10 -14 days and 4 months by both the researchers and the parents or care givers.
A satisfaction survey will be administered to the parent or guardian.
At 3-4 months, digital photographs of the healing lacerations will be graded for appearance by clinicians blinded to the repair method.
The initial visit will be billed to their insurance and the follow-up visits will be free.
研究の種類
介入
入学 (実際)
26
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。
研究場所
-
-
Missouri
-
Saint Louis、Missouri、アメリカ、63104
- cardinal glennon children's hospital / Division of Emergency Medicine
-
-
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
2年～17年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Any English-speaking child, 2 to 17 years of age that presents to the emergency department at Cardinal Glennon Children's Medical Center with a hand or foot laceration less than or equal to 2 cm is eligible for the study.
Exclusion Criteria:
- Patients will be excluded if their laceration is greater than 2 cm, have irregular borders or are, deeper than 0.5 cm.
- Wounds that are the result of a mammalian bite,
- Wounds more than minimally contaminated on visual inspection or are more than 8 hours old.
- Wounds associated with an open fracture, involve a partial amputation or involve a puncture wound.
- Wounds that involve the nailbed or a fingernail avulsion will be excluded.
- Patients with confirmed or suspected retained foreign bodies in the wound would also be excluded.
- Patients will also be excluded if hemostasis could not be attained after 15 minutes of pressure.
- Patients with complex lacerations who need plastic surgery or other sub-specialty repair will be excluded.
- Complex lacerations include: associated or suspected neurovascular, tendon, ligament, or bone injury, need for deep/multi-layer sutures will be excluded.
- Patients with known or suspected immunodeficiency, bleeding or clotting disorders, pregnancy, diabetes, renal dysfunction, or allergic reaction to local anesthesia are also excluded.
- Patients with a history of anticoagulant or chronic steroid use in the last year. Chronic steroid use is defined by use of steroids (PO, IV, IM, or topical) for more than 14 consecutive days, for more than 3 separate courses per year will be excluded.
- Foster children will also be excluded, due to complications regarding custody, consent, and follow-up issues.
- Patients with allergies to topical anesthetics solution will be excluded from the study.
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：conservative
patient fulfilling entry criteria will be randomized to the conservative arm - no suturing
|
|
|
アクティブコンパレータ：suture
patient fulfilling entry criteria will be randomized to the suture arm for repair with nylon suture material
|
Repair of wound with suture
Repair of wound with suture
|
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 |
|---|---|---|
|
Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair
時間枠：4 months
|
Randomized, parallel group study will compare cosmetic outcome by digital picture by blinded evaluators at 4 months post enrollment. The digital pictures of the laceration repairs were scored using a previously validated Visual Analogue Scale (VAS). The VAS scale is a 100-mm continuous line that is marked at the right end with "best appearance/scar"(score 100), and on the left end with "worst appearance/scar" (score 0). |
4 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Wound Healing in Hand and Feet Lacerations in Children: Conservative vs Suture Repair
時間枠：10-14 days
|
Wound healing by visual inspection at the first follow up visit. The wounds will be evaluated for complications that were defined a priori as follows: "wound infection" was one that required systemic antibiotics as determined by the treating attending physician; and "wound dehiscence" as a wound that required the placement of additional sutures or tissue adhesives. The outcome measure data is reported as the number of participants without the presence of "wound infection" or "wound dehiscence". |
10-14 days
|
|
Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair
時間枠：10-14 days
|
Infection rate by visual inspection.
The wounds will be evaluated for complications that were defined a priori as follows: "wound infection" was one that required systemic antibiotics as determined by the treating attending physician; and "wound dehiscence" as a wound that required the placement of additional sutures or tissue adhesives.
|
10-14 days
|
|
Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair
時間枠：10-14 days
|
Rate of wound dehiscence by visual inspection.
The wounds will be evaluated for complications that were defined a priori as follows: "wound infection" was one that required systemic antibiotics as determined by the treating attending physician; and "wound dehiscence" as a wound that required the placement of additional sutures or tissue adhesives.
|
10-14 days
|
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。
スポンサー
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 (実際)
2014年4月13日
一次修了 (実際)
2019年5月1日
研究の完了 (実際)
2019年5月1日
試験登録日
最初に提出
2017年9月22日
QC基準を満たした最初の提出物
2017年10月25日
最初の投稿 (実際)
2017年10月26日
学習記録の更新
投稿された最後の更新 (実際)
2020年10月9日
QC基準を満たした最後の更新が送信されました
2020年9月16日
最終確認日
2020年9月1日
詳しくは
本研究に関する用語
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?
はい
IPD プランの説明
if other facilities are performing similar studies would be happy to participate
IPD 共有時間枠
7/19
IPD 共有アクセス基準
By Appointment
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
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
はい
米国で製造され、米国から輸出された製品。
いいえ
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