Cosmetic Outcome at 4 Months in Hand and Feet Lacerations in Children: Conservative Versus Suture Repair
2020년 9월 16일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
26
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Missouri
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Saint Louis, Missouri, 미국, 63104
- cardinal glennon children's hospital / Division of Emergency Medicine
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
2년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: conservative
patient fulfilling entry criteria will be randomized to the conservative arm - no suturing
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활성 비교기: suture
patient fulfilling entry criteria will be randomized to the suture arm for repair with nylon suture material
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Repair of wound with suture
Repair of wound with suture
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Wound Healing in Hand and Feet Lacerations in Children: Conservative vs Suture Repair
기간: 10-14 days
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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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2014년 4월 13일
기본 완료 (실제)
2019년 5월 1일
연구 완료 (실제)
2019년 5월 1일
연구 등록 날짜
최초 제출
2017년 9월 22일
QC 기준을 충족하는 최초 제출
2017년 10월 25일
처음 게시됨 (실제)
2017년 10월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 10월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 9월 16일
마지막으로 확인됨
2020년 9월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
if other facilities are performing similar studies would be happy to participate
IPD 공유 기간
7/19
IPD 공유 액세스 기준
By Appointment
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .