봉투: 모소동 수술 후 상처 관리 (ENVELOP)
만성 모낭동 질환 관리를 위한 표준 상처 치료를 통한 절제 및 음압 상처 치료 대 절제 및 열린 채로 두는 방법 - 무작위 대조 시험
This is a single-blinded, multicentre, prospective randomised controlled trial (RCT) comparing post-operative and patient-reported outcomes for patients undergoing application of negative-pressure wound therapy (NPWT) after sinus tract excision as compared to excision and standard open wound care in chronic pilonidal sinus disease (PSD).
연구 개요
상세 설명
Pilonidal sinus disease (PSD) is a chronic inflammatory condition of the skin and subcutaneous tissues arising from hair follicles in the natal cleft. The definitive aetiology of the condition is unknown, however, it is theorised that it is the result of either the obstruction and subsequent inflammation of hair follicles or secondary to hair penetrating through the skin into the subcutaneous tissue. This results in infection, abscess formation, chronic discharge and pain. PSD is a common condition affecting 26 per 10,000 population, with the prevalence reaching 1.1% in young adult males.
PSD causes a significant burden on healthcare services due to high rates of recurrence and readmission following surgery, together with negative impacts on patients' quality of life and self-image. An effective management strategy for the disease is necessary to ensure that post-operative outcomes are optimised and patient-reported outcomes are satisfactory in those whose PSD requires surgery.
The objective of this multicentre, national RCT is to prospectively investigate the effect of negative pressure wound therapy compared to leaving open with standard wound care on time to wound healing following surgical excision of chronic PSD.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Sean T Martin
- 전화번호: (01) 261 4037
- 이메일: seanmartin@rcsi.ie
연구 연락처 백업
- 이름: Eanna Ryan
- 전화번호: (01) 261 4037
- 이메일: eannaryan@rcsi.com
연구 장소
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Castlebar, 아일랜드
- 모병
- Mayo University Hospital
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연락하다:
- Kevin Barry
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Dublin, 아일랜드
- 모병
- Tallaght University Hospital
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연락하다:
- Dara Kavanagh
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Dublin, 아일랜드, D09V2N0
- 모병
- Beaumont Hospital
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연락하다:
- John Burke
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Dublin, 아일랜드
- 모병
- St James's Hospital
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연락하다:
- Michael Kelly
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Dublin, 아일랜드
- 모병
- St Michael's Hospital, Dún Laoghaire
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연락하다:
- Helen Heneghan
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Dublin, 아일랜드
- 모병
- St Vincent's Univeristy Hospital
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연락하다:
- Eanna Ryan
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Kilkenny, 아일랜드
- 모병
- St. Luke's Hospital
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연락하다:
- Cathy Cronin
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Limerick, 아일랜드
- 모병
- University Hospital Limerick
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연락하다:
- Colin Peirce
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Tullamore, 아일랜드
- 모병
- Midlands University Hospital
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연락하다:
- Sean Johnston
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Waterford, 아일랜드
- 모병
- University Hospital Waterford
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연락하다:
- Peter Neary
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
i) They are aged 18 years or older
ii) They are undergoing elective pilonidal sinus excision without primary closure
Exclusion Criteria:
i) They are unable to adhere to protocol requirements e.g. questionnaire completion
ii) They are undergoing emergency drainage for a pilonidal abscess
iii) They are undergoing surgery for pilonidal sinus disease in locations other than the natal cleft
iv) They have underlying osteomyelitis
v) They have underlying fistulating disease e.g. Crohn's
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Negative Pressure Wound Therapy
The wound is dressed using negative pressure wound therapy. |
Following elective excision of chronic pilonidal sinus disease with the wound left open, NPWT is applied in theatre using a polyurethane foam-based system (e.g. VAC, Renasys-GO, Prevena or equivalent) cut to fit the wound cavity, sealed with an adhesive drape and connected to a portable pump at -125 mmHg continuous pressure. Dressings are changed every 48-72 hours in clinic until granulation reaches skin level, followed by standard dressings until epithelialisation. |
|
활성 비교기: Standard wound care (SWC)
Following excision, the wound is left open (no primary closure) and managed with standard dressings according to local protocol, with wound healing by secondary intention. |
Standard wound care |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to complete wound healing
기간: Up to 6 months post surgery
|
Number of days to complete epithelialisation or closure of the wound without any discharge, drainage, scab, and/or the requirement for further dressing. |
Up to 6 months post surgery
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Measure of post operative pain
기간: Day of surgery, 28 days post surgery & 3 months post surgery
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Pain measured by visual analogue pain scale (0 = no pain, 10 = worst pain) at rest, on walking and on sitting |
Day of surgery, 28 days post surgery & 3 months post surgery
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Measure of post operative complications
기간: 6 months post surgery
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Post-operative complications, including surgical site infection (CDC criteria), seroma, abscess, readmission and return to theatre. |
6 months post surgery
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To compare recurrence rates
기간: 6 months post surgery
|
To compare the 6-month recurrence rates (recurrence being defined as the development of a new sinus or abscess within the natal cleft occurring after wound healing had been achieved) between the NPWT and SWC Groups |
6 months post surgery
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Cost-effectiveness
기간: 6 months post surgery
|
Within-trial cost-utility analysis from health-system and patient perspectives, expressed as incremental cost per QALY gained (QALYs from EQ-5D-5L, area under the curve). Resource use includes hospital and community contacts, dressing changes, complications, readmissions and returns to theatre, valued at Irish unit costs; patient costs and productivity losses via CoPaQ. |
6 months post surgery
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Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
기간: Baseline, 1 month, 3 months & 6 months
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The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Index values derived using the EQ-5D-5L value set specified in the Statistical Analysis Plan (Irish value set where available). |
Baseline, 1 month, 3 months & 6 months
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Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
기간: 28 days, 3 months, 6 months
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The POSAS is made up of two scales: the patient and observer scales each comprise six items scored 1 to 10; each scale is summed (6 = normal, 60 = worst) and reported separately. |
28 days, 3 months, 6 months
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Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
기간: 28 days, 3 months, 6 months
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The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition |
28 days, 3 months, 6 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Sean T Martin, St. James's Hospital, Ireland
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RCSI-ENVELOP
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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