- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02355691
Improvement in Wound Healing With Negative Pressure Wound Therapy for Postoperative Total Hip Arthroplasty
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- UNC Orthopaedics
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adult patients undergoing primary total hip arthroplasty.
Exclusion Criteria:
- age less than 18 y/o
- Total hip arthroplasty for fracture
- Revision or conversion total hip arthroplasty
- inability to personally consent to participation due to cognitive impairment, intoxication or sedation
- multiple surgical procedures
- Patients taking immune modulating medication(prednisone, methotrexate, anakinra, etc.)
- skin hypersensitivity to acrylic adhesive or silver.
- Inability to care for dressing due to physical or mental incapacitation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: PREVENA Group
Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty.
This dressing will be used for a period of seven days.
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The device is a sealed negative pressure wound therapy tool.
The device will be placed on the skin during surgery and left in place until their followup at 7 days.
다른 이름들:
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간섭 없음: Standard group
Patients will be treated with the standard absorptive dressing following total hip arthroplasty.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mean Wound Healing Scores by the ASEPSIS Criteria
기간: (Single point evaluation)-2 weeks post surgery visit
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A method of evaluating wounds for infection risk that incorporates multiple wound healing factors such as erythema, drainage, and dehiscence is the ASEPSIS (Additional treatment, presence of Serous discharge, Erythema, Purulent exudate, Separation of the deep tissue, Isolation of bacteria, and duration of inpatient Stay) wound scoring system.
Originally developed and validated for cardiac surgery sternal wounds, ASEPSIS evaluates the wound for the severity of multiple factors linked with surgical site infection.
This includes dehiscence, exudate/discharge, and erythema.
The higher the score, the more likely a surgical site infection will be present.
This score will give us a more diverse picture of postoperative wound healing and the influence of Negative Pressure Wound Therapy.
Scores can range from 0 to 65, with most scores expected at the lower scale.
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(Single point evaluation)-2 weeks post surgery visit
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Participants With Infection
기간: (Single point evaluation)-6 weeks post surgery visit
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The investigators will continue to monitor the patients for development of an acute postoperative infection. A deep infection refers to an infection below the superficial soft tissue and likely involving the prosthesis. This will be evaluated by the musculoskeletal infection society consensus on total joint infection. Criteria include:(Either one major criteria or four minor criteria) Major criteria Sinus track communicating with the prosthesis Two separate cultures from the joint positive for the same organism Minor criteria Elevated erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) Elevated synovial leukocyte count Elevated synovial neutrophil percentage Purulent drainage from the joint One positive fluid culture from the joint Histological analysis of tissue showing more than 5 neutrophils per high power field in 5 fields |
(Single point evaluation)-6 weeks post surgery visit
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공동 작업자 및 조사자
수사관
- 수석 연구원: Daniel J Del Gaizo, MD, UNC Orthopaedics
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
PREVENA에 대한 임상 시험
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St. James's Hospital, Ireland아직 모집하지 않음
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-
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-
3M빼는슬관절 전치환술 | 고관절 전치환술 | 선형 또는 Emi-linear 절개
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Abbey Hardy-FairbanksKinetic Concepts, Inc.완전한
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University of PennsylvaniaKinetic Concepts, Inc.완전한