Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524401
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the safety and effectiveness of the Limpet as compared to standard of care ostomy pouches in reducing complications for ostomy and fistula patients Secondary objectives include evaluating dressing leak rates and causes of complications eg edema tissue oxygen saturation and poor stoma eversion The main questions it aims to answer are
Primary Hypothesis 1 Peristomal Skin Complications will decrease
Primary Hypothesis 2 Dressing Leak Rates will decrease
Participants will
Receive either the Limpet device or standard of care adhesive ostomy pouch dressing
Return every 7 days for study visits for 30 days to receive device replacement wound imaging blood tests and quality of life surveys
Primary Hypothesis 1 Peristomal Skin Complications will decrease
Primary Hypothesis 2 Dressing Leak Rates will decrease
Participants will
Receive either the Limpet device or standard of care adhesive ostomy pouch dressing
Return every 7 days for study visits for 30 days to receive device replacement wound imaging blood tests and quality of life surveys
Detailed Description:
The Limpet is a single-use device intended for effluent management and promotion of healing of intact and injured skin surrounding enterocutaneous fistulae and ostomies
Our study focuses on small bowel openings encompassing two important cohorts 1 ileostomy and 2 enterocutaneous fistulas ECFs Our studys success criterion is primarily based on the pooled results from both cohorts
Primary Hypothesis 1 Peristomal Skin Complications PSCs We hypothesize that the Limpet will demonstrate a significant improvement in PSCs compared to standard of care adhesive ostomy pouches Specifically we anticipate a raw difference of 35 in PSCs for the pooled cohorts with a complication rate of 50 in the control group and 15 in the Limpet group
Primary Hypothesis 2 Dressing Leak Rates We hypothesize that the Limpet will demonstrate a significant improvement in dressing leak rates compared to standard of care adhesive ostomy pouches Specifically we anticipate a raw difference of 15 in leak rates for the pooled cohorts with a leak rate of 30 in the control group and 15 in the Limpet group
These hypotheses are grounded in existing literature supplemented by clinical experience We intend to conduct subgroup analyses to assess the treatment effect across the two cohorts ileostomy and ECF and across other relevant subgroups such as gender race etc
Secondary Hypothesis Total Complications PSCs and Stomal Complications We hypothesize that the Limpet will exhibit a raw difference of 35 in total complications comprising PSCs and stomal complications like mucocutaneous separation and stoma retraction for the ileostomy cohort Stoma complication rates vary widely in the literature and we plan to conduct sub analyses to evaluate the Limpets effect on stoma complications independent of PSCs
This will be a 30 day single-site randomized controlled trial RCT for a non-significant risk device Limpet
The study will have a two-arm parallel group design
Limpet Participants in this arm will utilize the subject device as intended to be used
Control Standard treatment with standard of care adhesive ostomy pouches
Ninety-two participants 78 stoma and 14 enterocutaneous fistula participants will be randomized after they have consented to study participation Initial randomization will occur in a 11 ratio Limpet and Control Participants will be randomly stratified with permuted blocks by BMI vs 40 and stoma type loop ileostomy end ileostomy or enterocutaneous fistula to account differences in healing and wound severity
This study will be conducted at HealthPartners Institutes Regions Hospital in St Paul Minnesota Data compiled by the Wound Ostomy and Continence Nursing Department reveals an annual pool of more than 300 eligible patients at Regions Hospital
The study will consist of the following visits
Visit C1 Day -35 to -6 Screening in-person clinic visit
Visit C2 Day 1 Baseline appointment clinic visit
Visit C3 Week 1 Clinic visit
Visit C4 Week 2 Clinic visit
Visit C5 Week 3 Clinic visit
Visit C6 Week 4 Final appointment during treatment period clinic visit
After the Baseline Data Collection Period participants will be randomized by BMI and three stoma types ileostomy with loop stoma ileostomy with end stoma and enterocutaneous fistulas ECFs into 1 of 2 treatment groups
Limpet Participants in this arm will utilize the subject device as intended to be used
Control Standard treatment with standard of care adhesive ostomy pouches
On Day 1 Limpet participants will have their device placed by a clinician Upon discharge a portable vacuum pump will be issued to provide negative pressure eg 3M Prevena or Snap ConvaTec Avelle or Pensar MicroDoc These systems are compact fit in a pocket are simple to operate and commonly used in the outpatient setting to provide multiple weeks of therapy Participants will be furnished with materials to address potential dressing problems while at home extra waste pouches adhesive drape strips for sealing air leaks and standard of care adhesive ostomy pouches and accessories as a backup plan in the event of a Limpet failure
On Day 1 Control participants will receive standard of care adhesive ostomy pouch dressings Participants will be furnished with materials to address potential dressing problems while at home adhesive ostomy pouches and accessories for pouch replacement The Control group will change their pouches at home 2 to 5 times per week or more frequently if needed as per the current standard of care
The brand and model of pumps and adhesive ostomy pouches used by Limpet and Control participants will be recorded for comparison purposes Participants will return for clinic visits approximately every 7 days to have their device replaced Participants will have their final study appointment approximately 30 days post-surgery Clinical support will help the participant troubleshoot dressing problems and if necessary bring the patient into the study site for an immediate dressing change
Our study focuses on small bowel openings encompassing two important cohorts 1 ileostomy and 2 enterocutaneous fistulas ECFs Our studys success criterion is primarily based on the pooled results from both cohorts
Primary Hypothesis 1 Peristomal Skin Complications PSCs We hypothesize that the Limpet will demonstrate a significant improvement in PSCs compared to standard of care adhesive ostomy pouches Specifically we anticipate a raw difference of 35 in PSCs for the pooled cohorts with a complication rate of 50 in the control group and 15 in the Limpet group
Primary Hypothesis 2 Dressing Leak Rates We hypothesize that the Limpet will demonstrate a significant improvement in dressing leak rates compared to standard of care adhesive ostomy pouches Specifically we anticipate a raw difference of 15 in leak rates for the pooled cohorts with a leak rate of 30 in the control group and 15 in the Limpet group
These hypotheses are grounded in existing literature supplemented by clinical experience We intend to conduct subgroup analyses to assess the treatment effect across the two cohorts ileostomy and ECF and across other relevant subgroups such as gender race etc
Secondary Hypothesis Total Complications PSCs and Stomal Complications We hypothesize that the Limpet will exhibit a raw difference of 35 in total complications comprising PSCs and stomal complications like mucocutaneous separation and stoma retraction for the ileostomy cohort Stoma complication rates vary widely in the literature and we plan to conduct sub analyses to evaluate the Limpets effect on stoma complications independent of PSCs
This will be a 30 day single-site randomized controlled trial RCT for a non-significant risk device Limpet
The study will have a two-arm parallel group design
Limpet Participants in this arm will utilize the subject device as intended to be used
Control Standard treatment with standard of care adhesive ostomy pouches
Ninety-two participants 78 stoma and 14 enterocutaneous fistula participants will be randomized after they have consented to study participation Initial randomization will occur in a 11 ratio Limpet and Control Participants will be randomly stratified with permuted blocks by BMI vs 40 and stoma type loop ileostomy end ileostomy or enterocutaneous fistula to account differences in healing and wound severity
This study will be conducted at HealthPartners Institutes Regions Hospital in St Paul Minnesota Data compiled by the Wound Ostomy and Continence Nursing Department reveals an annual pool of more than 300 eligible patients at Regions Hospital
The study will consist of the following visits
Visit C1 Day -35 to -6 Screening in-person clinic visit
Visit C2 Day 1 Baseline appointment clinic visit
Visit C3 Week 1 Clinic visit
Visit C4 Week 2 Clinic visit
Visit C5 Week 3 Clinic visit
Visit C6 Week 4 Final appointment during treatment period clinic visit
After the Baseline Data Collection Period participants will be randomized by BMI and three stoma types ileostomy with loop stoma ileostomy with end stoma and enterocutaneous fistulas ECFs into 1 of 2 treatment groups
Limpet Participants in this arm will utilize the subject device as intended to be used
Control Standard treatment with standard of care adhesive ostomy pouches
On Day 1 Limpet participants will have their device placed by a clinician Upon discharge a portable vacuum pump will be issued to provide negative pressure eg 3M Prevena or Snap ConvaTec Avelle or Pensar MicroDoc These systems are compact fit in a pocket are simple to operate and commonly used in the outpatient setting to provide multiple weeks of therapy Participants will be furnished with materials to address potential dressing problems while at home extra waste pouches adhesive drape strips for sealing air leaks and standard of care adhesive ostomy pouches and accessories as a backup plan in the event of a Limpet failure
On Day 1 Control participants will receive standard of care adhesive ostomy pouch dressings Participants will be furnished with materials to address potential dressing problems while at home adhesive ostomy pouches and accessories for pouch replacement The Control group will change their pouches at home 2 to 5 times per week or more frequently if needed as per the current standard of care
The brand and model of pumps and adhesive ostomy pouches used by Limpet and Control participants will be recorded for comparison purposes Participants will return for clinic visits approximately every 7 days to have their device replaced Participants will have their final study appointment approximately 30 days post-surgery Clinical support will help the participant troubleshoot dressing problems and if necessary bring the patient into the study site for an immediate dressing change
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None