Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06242925
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-01-29
Brief Title:
Assessment of a Non-invasive Device in the Management of Open Abdomen AbCLO
Sponsor:
Tufts Medical Center
Organization:
Tufts Medical Center
Study Overview
Official Title:
Assessment of a Non-invasive Device in the Management of Open Abdomen AbCLO- Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AbCLO
Brief Summary:
The goal of this multicenter prospective Cohort Interventional study is to perform a pilot study of the AbCLO Abdominal Wall Closure device in patients with Open Abdomen The main question it aims to answer is
Does the Abdominal Wall Closure Device AbCLO increase the likelihood of primary facial closure in cases of open abdomen when compared to historical controls
Participants will be cases of open abdomen who underwent emergency surgery for Trauma or Acute Care Surgery will have the AbCLO device These will be compared to historical controls managed at the same center
Does the Abdominal Wall Closure Device AbCLO increase the likelihood of primary facial closure in cases of open abdomen when compared to historical controls
Participants will be cases of open abdomen who underwent emergency surgery for Trauma or Acute Care Surgery will have the AbCLO device These will be compared to historical controls managed at the same center
Detailed Description:
This is a multi-center matched prospective cohort study It will be performed in collaboration between 2 centers in the USA Tufts Medical Center TMC and Los Angeles County University of Southern California LAC USC Medical Center
The cohort interventional patients will receive the standard of care Lahey bag Ioban and closed suction drains in addition to the study intervention AbCLO Device
The control group is retrospective patients that were previously managed at the same center regardless of the technique or the device used to close the OA
The total sample size is 80 patients 20 in the treatment arm 15 from TMC and 5 from LACUSC and 60 in the control arm 45 from TMC and 15 from LACUSC The treatment arm will be matched to historical control based on the following pre-specified variables
1 Age
2 Diagnosis trauma case vs acute general surgery cases
3 Assessment of severity Injury severity scores ISS for Trauma cases and APACHEII score for acute general surgery cases
Outcome Data
1 Primary Outcome Proportion of patients achieved primary facial closure within 14 days This is defined as approximation of the fascia on either side of the midline to perform suture closure without using any mesh or additional procedures From our experience most open abdomen is usually closed within 7-10 days We decided to put any closure more than 14 days is considered failure of the device
2 Proportion of patients that require component separation andor mesh closure to obtain fascial closure if we need to use mesh or do additional procedure to close the abdomen this is considered failure rate of the ABCLO device
3 Percentage of patients requiring additional device such as Whitmans patch to maintain fascial closure this is also considered failure of the ABCLO device
4 The time from inclusion to complete abdominal wall fascial closure as defined above prior to discharge Duration of patients that require the abdomen to be open
5 Percentage of patients developing pressure ulcers as a possible complication of the device
6 Duration of mechanical ventilation ICU length of stay and hospital length of stay to examine the indirect effects of primary fascial closure on these outcomes
7 Total cost per patient before and after application of the ABCLO from ICU admission to closure of the abdomen
The cohort interventional patients will receive the standard of care Lahey bag Ioban and closed suction drains in addition to the study intervention AbCLO Device
The control group is retrospective patients that were previously managed at the same center regardless of the technique or the device used to close the OA
The total sample size is 80 patients 20 in the treatment arm 15 from TMC and 5 from LACUSC and 60 in the control arm 45 from TMC and 15 from LACUSC The treatment arm will be matched to historical control based on the following pre-specified variables
1 Age
2 Diagnosis trauma case vs acute general surgery cases
3 Assessment of severity Injury severity scores ISS for Trauma cases and APACHEII score for acute general surgery cases
Outcome Data
1 Primary Outcome Proportion of patients achieved primary facial closure within 14 days This is defined as approximation of the fascia on either side of the midline to perform suture closure without using any mesh or additional procedures From our experience most open abdomen is usually closed within 7-10 days We decided to put any closure more than 14 days is considered failure of the device
2 Proportion of patients that require component separation andor mesh closure to obtain fascial closure if we need to use mesh or do additional procedure to close the abdomen this is considered failure rate of the ABCLO device
3 Percentage of patients requiring additional device such as Whitmans patch to maintain fascial closure this is also considered failure of the ABCLO device
4 The time from inclusion to complete abdominal wall fascial closure as defined above prior to discharge Duration of patients that require the abdomen to be open
5 Percentage of patients developing pressure ulcers as a possible complication of the device
6 Duration of mechanical ventilation ICU length of stay and hospital length of stay to examine the indirect effects of primary fascial closure on these outcomes
7 Total cost per patient before and after application of the ABCLO from ICU admission to closure of the abdomen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None