Trial Outcomes & Findings for Open Abdomen Study Comparing ABThera™ Open Abdomen Negative Pressure Therapy System and Barker's Vacuum Packing Technique (NCT NCT01016353)

NCT ID: NCT01016353

Last Updated: 2024-12-02

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 283 participants
• Primary outcome timeframe: Up to 30 days
• Results posted on: 2024-12-02

Participant Flow

Participant milestones

Measure	NPWT ABThera Open Abdomen Negative Pressure Therapy System	BVPT Barker's vacuum-packing technique (BVPT)
Overall Study STARTED	180	103
Overall Study COMPLETED	178	102
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open Abdomen Study Comparing ABThera™ Open Abdomen Negative Pressure Therapy System and Barker's Vacuum Packing Technique

Baseline characteristics by cohort

Measure	NPWT n=178 Participants ABThera Open Abdomen Negative Pressure Therapy System	BVPT n=102 Participants Barker's vacuum-packing technique (BVPT)	Total n=280 Participants Total of all reporting groups
Age, Continuous	40 years STANDARD_DEVIATION 17 • n=5 Participants	39 years STANDARD_DEVIATION 16 • n=7 Participants	40 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	28 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	142 Participants n=5 Participants	74 Participants n=7 Participants	216 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · American Indian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black or African American	54 Participants n=5 Participants	40 Participants n=7 Participants	94 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic or Latino	37 Participants n=5 Participants	10 Participants n=7 Participants	47 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Native Hawaiian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	81 Participants n=5 Participants	47 Participants n=7 Participants	128 Participants n=5 Participants
Region of Enrollment United States	178 Participants n=5 Participants	102 Participants n=7 Participants	280 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 30 days

Outcome measures

Measure	NPWT n=178 Participants ABThera Open Abdomen Negative Pressure Therapy System	BVPT n=102 Participants Barker's vacuum-packing technique (BVPT)
Number of Participants With Primary Fascial Closure	139 Participants	69 Participants

Adverse Events

NPWT

Serious events: 3 serious events

Other events: 65 other events

Deaths: 21 deaths

BVPT

Serious events: 0 serious events

Other events: 36 other events

Deaths: 20 deaths

Serious adverse events

Measure	NPWT n=180 participants at risk ABThera Open Abdomen Negative Pressure Therapy System	BVPT n=103 participants at risk Barker's vacuum-packing technique (BVPT)
Gastrointestinal disorders Abdominal Compartment Syndrome	1.7% 3/180 • 30 day All-cause mortality was an endpoint for the study, therefore it was reported based on the mITT population rather than the safety population. mITT population included subjects who received any study-related TAC, regardless of its duration, had a valid baseline, and at least 1 post baseline assessment for any of the study efficacy parameters.	0.00% 0/103 • 30 day All-cause mortality was an endpoint for the study, therefore it was reported based on the mITT population rather than the safety population. mITT population included subjects who received any study-related TAC, regardless of its duration, had a valid baseline, and at least 1 post baseline assessment for any of the study efficacy parameters.

Other adverse events

Measure	NPWT n=180 participants at risk ABThera Open Abdomen Negative Pressure Therapy System	BVPT n=103 participants at risk Barker's vacuum-packing technique (BVPT)
Gastrointestinal disorders Abdominal Adhesions	5.0% 9/180 • 30 day All-cause mortality was an endpoint for the study, therefore it was reported based on the mITT population rather than the safety population. mITT population included subjects who received any study-related TAC, regardless of its duration, had a valid baseline, and at least 1 post baseline assessment for any of the study efficacy parameters.	5.8% 6/103 • 30 day All-cause mortality was an endpoint for the study, therefore it was reported based on the mITT population rather than the safety population. mITT population included subjects who received any study-related TAC, regardless of its duration, had a valid baseline, and at least 1 post baseline assessment for any of the study efficacy parameters.
Infections and infestations Abdominal Infection	5.6% 10/180 • 30 day All-cause mortality was an endpoint for the study, therefore it was reported based on the mITT population rather than the safety population. mITT population included subjects who received any study-related TAC, regardless of its duration, had a valid baseline, and at least 1 post baseline assessment for any of the study efficacy parameters.	9.7% 10/103 • 30 day All-cause mortality was an endpoint for the study, therefore it was reported based on the mITT population rather than the safety population. mITT population included subjects who received any study-related TAC, regardless of its duration, had a valid baseline, and at least 1 post baseline assessment for any of the study efficacy parameters.
Gastrointestinal disorders Gastrointestinal Necrosis	6.7% 12/180 • 30 day All-cause mortality was an endpoint for the study, therefore it was reported based on the mITT population rather than the safety population. mITT population included subjects who received any study-related TAC, regardless of its duration, had a valid baseline, and at least 1 post baseline assessment for any of the study efficacy parameters.	1.9% 2/103 • 30 day All-cause mortality was an endpoint for the study, therefore it was reported based on the mITT population rather than the safety population. mITT population included subjects who received any study-related TAC, regardless of its duration, had a valid baseline, and at least 1 post baseline assessment for any of the study efficacy parameters.
Gastrointestinal disorders Intra-Abdominal Hypertension	12.2% 22/180 • 30 day All-cause mortality was an endpoint for the study, therefore it was reported based on the mITT population rather than the safety population. mITT population included subjects who received any study-related TAC, regardless of its duration, had a valid baseline, and at least 1 post baseline assessment for any of the study efficacy parameters.	8.7% 9/103 • 30 day All-cause mortality was an endpoint for the study, therefore it was reported based on the mITT population rather than the safety population. mITT population included subjects who received any study-related TAC, regardless of its duration, had a valid baseline, and at least 1 post baseline assessment for any of the study efficacy parameters.
Gastrointestinal disorders Intraloop Adhesions	8.3% 15/180 • 30 day All-cause mortality was an endpoint for the study, therefore it was reported based on the mITT population rather than the safety population. mITT population included subjects who received any study-related TAC, regardless of its duration, had a valid baseline, and at least 1 post baseline assessment for any of the study efficacy parameters.	0.97% 1/103 • 30 day All-cause mortality was an endpoint for the study, therefore it was reported based on the mITT population rather than the safety population. mITT population included subjects who received any study-related TAC, regardless of its duration, had a valid baseline, and at least 1 post baseline assessment for any of the study efficacy parameters.
Musculoskeletal and connective tissue disorders Loss of Fascial Domain	7.8% 14/180 • 30 day All-cause mortality was an endpoint for the study, therefore it was reported based on the mITT population rather than the safety population. mITT population included subjects who received any study-related TAC, regardless of its duration, had a valid baseline, and at least 1 post baseline assessment for any of the study efficacy parameters.	8.7% 9/103 • 30 day All-cause mortality was an endpoint for the study, therefore it was reported based on the mITT population rather than the safety population. mITT population included subjects who received any study-related TAC, regardless of its duration, had a valid baseline, and at least 1 post baseline assessment for any of the study efficacy parameters.
General disorders Mulitple Organ Dysfunction Syndrome	6.7% 12/180 • 30 day All-cause mortality was an endpoint for the study, therefore it was reported based on the mITT population rather than the safety population. mITT population included subjects who received any study-related TAC, regardless of its duration, had a valid baseline, and at least 1 post baseline assessment for any of the study efficacy parameters.	11.7% 12/103 • 30 day All-cause mortality was an endpoint for the study, therefore it was reported based on the mITT population rather than the safety population. mITT population included subjects who received any study-related TAC, regardless of its duration, had a valid baseline, and at least 1 post baseline assessment for any of the study efficacy parameters.
Infections and infestations Sepsis	8.9% 16/180 • 30 day All-cause mortality was an endpoint for the study, therefore it was reported based on the mITT population rather than the safety population. mITT population included subjects who received any study-related TAC, regardless of its duration, had a valid baseline, and at least 1 post baseline assessment for any of the study efficacy parameters.	10.7% 11/103 • 30 day All-cause mortality was an endpoint for the study, therefore it was reported based on the mITT population rather than the safety population. mITT population included subjects who received any study-related TAC, regardless of its duration, had a valid baseline, and at least 1 post baseline assessment for any of the study efficacy parameters.

Additional Information

Senior Director, Global Clinical Development

KCI

Phone: (210) 255-5595

Email: jane.hart@kci1.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60