TissuePAtchDS--P ™ PArotidectomy 시험. (TAPAS)
TissuePAtchDS-P를 사용하면 주간 PArotid 수술이 가능합니까? 양성 표재 귀밑샘 절제술에서 TissuePatchDS-P 대 외과적 배액술을 비교하는 무작위 대조 우월성 시험.
The parotid (salivary) gland can develop growths (tumours), most of which are not cancerous but may develop into a cancer if left untreated. Tumours located near the surface of the gland are surgically removed in a procedure called a superficial parotidectomy. Post-surgery, fluid accumulates in the space left behind by the gland and currently, this is managed via insertion of a surgical drain (tube attached to a vacuumed bottle). Patients are then routinely admitted to hospital for 24-48 hours until it is safe for the drain to be removed.
As well as the need for a prolonged hospital stay, there are known risks associated with drains e.g. infection, fluid collection under the skin (seroma) and communication between parotid tissue and the skin (fistula). This study aims to evaluate the effectiveness of applying an adhesive sealant (TissuePatchDS-P) between the parotid gland and the skin after removal of a non-cancerous parotid tumour. This would be instead of a surgical drain, as the sealant closes the space and should prevent fluid build-up. This may allow for same-day discharge and reduce complications.
연구 개요
상세 설명
The parotid (salivary) gland can develop growths (tumours), most of which are not cancerous but may develop into a cancer if left untreated. Tumours located near the surface of the gland are surgically removed in a procedure called a superficial parotidectomy. Post-surgery, fluid accumulates in the space left behind by the gland and currently, this is managed via insertion of a surgical drain (tube attached to a vacuumed bottle). Patients are then routinely admitted to hospital for 24-48 hours until it is safe for the drain to be removed.
As well as the need for a prolonged hospital stay, there are known risks associated with drains e.g. infection, fluid collection under the skin (seroma) and communication between parotid tissue and the skin (fistula). This study aims to evaluate the effectiveness of applying an adhesive sealant (TissuePatchDS-P) between the parotid gland and the skin after removal of a non-cancerous parotid tumour. This would be instead of a surgical drain, as the sealant closes the space and should prevent fluid build-up. This may allow for same-day discharge and reduce complications.
As no trials to date have used TissuePatchDS-P without a surgical drain, this study will run in two phases - an assessment/pilot phase with 5 participants using TissuePatchDS-P only. This will include compulsory overnight stay and ultrasound scan within 24 hours to ensure safety before progressing to the randomised controlled trial phase. In this phase, 50 participants will be randomised to receive either: surgical drain (standard care) or TissuePatchDS-P. After surgery, patients in both groups will be reviewed by their care team and discharged when appropriate.
Participants will be followed up at their routine 6-week post-surgical visit and then a trial doctor will conduct a study-related telephone consultation at 3 months post-surgery for long-term assessment of safety, clinical outcomes and quality of life.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Dorset
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Poole, Dorset, 영국, BH15 2JB
- Poole Hospital NHSFT
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- All patients undergoing superficial parotidectomy for benign parotid disease.
- Patients 18 years of age or above.
Exclusion Criteria:
- American Society of Anesthesiologists (ASA) classification >2 and/or Body Mass Index (BMI) >35.
- Any patient with malignant, infected/inflamed or recurrent parotid disease.
- Patients taking immunosuppressants.
- Patients with a history of allergic reaction to the composites of the patch
- Previous parotid surgery to the same side.
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 |
|---|---|
|
실험적: Intervention
Placement of TissuePatchDS-P™ at time of operation. No surgical drain is used. |
The therapy to be used in the intervention arm is TissuePatchDS-P™. This is a preformed, standard-sized artificial adhesive that will be used between the parotid tissue and subcutaneous tissue. It can be cut to an appropriate size for the defect. The intention of this installation is to seal and close the potential space that is created with removal of superficial parotid tissue |
|
활성 비교기: Control
No use of TissuePatchDS-P™. Wound is closed with a surgical drain (Surgeon's choice) in situ. |
A surgical drain used in superficial parotid surgery is a thin polyvinylchloride (PVC) tube, with perforations at the end, which is placed at the end of the procedure before the surgical wound is closed in the cavity created following removal of parotid tissue. The tube is connected to a closed vacuum system attached to a plastic bottle outside of the patient's body which acts to remove the fluid that collects after an operation. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of Participants Discharged at Day 0 Following Superficial Parotidectomy
기간: Day one
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Proportion of participants discharged at day 0 following superficial parotidectomy. |
Day one
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Complications
기간: Three months
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Number of complications (e.g. haematoma, seroma, salivary fistula and symptomatic Frey's syndrome) |
Three months
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European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN35)
기간: Three months
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN35): Disease-specific measure to assess quality of life among patients with advanced head and neck cancer. Data are unavailable for this outcome measure - not analysed due to termination of trial & records have now reached the end of their archiving retention period. |
Three months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
기타 연구 ID 번호
- SP170310A
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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