NCT07460323招募中不适用
Study of TRE Seals on Early Post-operative Subjects
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 107
- 试验地点
- 6
- 主要终点
- The Risk of Peristomal Skin Complications (PSCs) as measured using the three PSC-related questions on the Ostomy Complication Severity Index (OCSI)
研究概览
简要总结
This study will evaluate two Ostomy Seals/Rings in a group of post-operative patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Has their ostomy surgery and post-operative care in the United Kingdom (UK)
- •Has a colostomy, ileostomy, or urostomy and no reversal planned during the study evaluation period
- •Able to have first study product applied at first pouch change after surgery (or up to 4 days post-op)
- •Is appropriate to use a barrier seal per the Investigator
- •Able to provide an informed consent for study participation
- •Willing to follow protocol procedures, including participating in study visits, as demonstrated by signing the informed consent
排除标准
- •Is over 85 years of age
- •Has received chemotherapy or radiation in the past 30 days or reports beginning chemotherapy or radiation during the study.
- •A score of 1, 2, or 3 for any of the three OCSI Tool PSC-related domains (i.e., peristomal irritant dermatitis, peristomal bleeding, and hyperplasia) at time of enrollment
- •Has a fistula in the peristomal area at time of enrollment
- •Has an open draining wound (not including mucocutaneous separation) in the peristomal area at time of enrollment
- •Has a suspected infection in the peristomal area at time of enrollment
- •Is pregnant or lactating at time of enrollment (as determined by interview only)
- •Is unable to speak, read, and understand English.
- •Is currently participating in another clinical study using ostomy products
- •Is currently an employee of Hollister Incorporated or any ostomy manufacturer
研究组 & 干预措施
An Ostomy Seal
Experimental
干预措施: An Ostomy Seal (Device)
An Ostomy Ring
Active Comparator
干预措施: An Ostomy Ring (Device)
结局指标
主要结局
The Risk of Peristomal Skin Complications (PSCs) as measured using the three PSC-related questions on the Ostomy Complication Severity Index (OCSI)
时间窗: From enrollment to the end of treatment at 9 weeks
The three PSC-related questions on the Ostomy Complication Severity Index (OCSI) are related to peristomal irritant dermatitis, peristomal bleeding, and hyperplasia. Each of these three items is rated on a scale of 0-3, with 0 indicating absence of the condition, and 3 indicating the condition is severe.
次要结局
- Total Ostomy Complication Severity Index (OCSI) score and six stomal complication (non-PSC) domains of the OCSI and associated severity(From enrollment to the end of treatment at 9 weeks)
- Mediation of peristomal skin complications (PSCs) by leakage absorption measured using the leakage item on the Ostomy Complication Severity Index (OCSI)(From enrollment to the end of treatment at 9 weeks)
- Visible moisture/effluent on peristomal skin under the study seal area (OCSI Supplementary Question)(From enrollment to the end of treatment at 9 weeks)
- Seal absorption of moisture/effluent under the study seal area (OCSI Supplementary Question)(From enrollment to end of treatment at 9 weeks)
- Presence of peristomal skin conditions (OCSI Supplementary Question)(From enrollment to end of treatment at 9 weeks)
- Peristomal skin burning severity (OCSI Supplementary Question)(From enrollment to end of treatment at 9 weeks)
- Peristomal skin itching severity (OCSI Supplementary Question)(From enrollment to end of treatment at 9 weeks)
- Time to resolution of peristomal skin complications (PSCs), assessed by the Ostomy Complication Severity Instrument (OCSI) at visits and adverse event (AE) reports between visits(From first PSC onset to resolution through end of treatment at 9 weeks)
- Time to recurrence of peristomal skin complications (PSCs) after resolution, assessed by the OCSI at visits and AE reports between visits(From PSC resolution to first recurrence through end of treatment at 9 weeks)
- Proportion of participants with PSC occurrence, PSC resolution, and PSC recurrence, assessed by the OCSI at visits and AE reports between visits(From enrollment to end of treatment at 9 weeks)
- Patient satisfaction with the study Seal/Ring assessed using the Study-Specific Patient Satisfaction Questionnaire (Likert scale)(From enrollment to the end of treatment at 9 weeks)
- Clinician Satisfaction with the study Seal/Ring assessed using the Study-Specific Clinician Satisfaction Questionnaire (Likert scale)(From enrollment to the end of treatment at 9 weeks)
- Ability to correctly use the seal/ring with available instructional resources, assessed by the Study-Specific Instructional Resources Question(From enrollment to the end of treatment at 9 weeks)
- Seal swelling/expansion incidence, assessed by Study-Specific Swell/Expand Question(From enrollment to the end of treatment at 9 weeks)
- Effectiveness of seal swelling/expansion for secure fit against leakage, assessed by Study-Specific Swell/Expand Question(From enrollment to end of treatment at 9 weeks)
- Perceived moisture-wicking effect, assessed by the Study-Specific Moisture-Wicking Question (3-point scale)(From enrollment to the end of treatment at 9 weeks)
- Clinician agreement with the study Seal/Ring performance assessed using the Study-Specific Clinician Agreement Questionnaire (Likert scale)(From enrollment to the end of treatment at 9 weeks)
- Quantity of seals/rings, barriers, and accessories used, assessed by Study-Specific Resource Utilization Log(From enrollment to the end of treatment at 9 weeks)
- Wear/use time (longevity) of seals/rings and barriers, assessed by Study-Specific Resource Utilization Log(From enrollment to end of treatment at 9 weeks)
- Peristomal skin-related unplanned healthcare visits, assessed by Study-Specific Healthcare Utilization Question(From enrollment to end of treatment at 9 weeks)
- Total ostomy seal/ring costs, derived from quantities recorded in the Resource and Healthcare Utilization Logs(From enrollment to end of treatment at 9 weeks)
研究者
研究点 (6)
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