Trial Outcomes & Findings for The Management of Closed Surgical Incisions Resulting From Incisional Hernia Repair and/or Functional Panniculectomy Using the Prevena™ Customizable™ Dressing (NCT NCT02302222)

NCT ID: NCT02302222

Last Updated: 2024-10-16

Results Overview

Surgical Site Complications: * Dehiscence * Surgical site infection (SSI)

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 71 participants
• Primary outcome timeframe: Within 30 Days Post-Surgical Procedure
• Results posted on: 2024-10-16

Participant Flow

Participant milestones

Measure	Standard of Care dry sterile dressing/gauze and steristrips	Customizable Customizable Dressing with ActiV.A.C. Therapy Unit
Overall Study STARTED	34	37
Overall Study COMPLETED	33	31
Overall Study NOT COMPLETED	1	6

Reasons for withdrawal

Measure	Standard of Care dry sterile dressing/gauze and steristrips	Customizable Customizable Dressing with ActiV.A.C. Therapy Unit
Overall Study Physician Decision	0	4
Overall Study Lost to Follow-up	1	0
Overall Study Treatment discontinued before day 5	0	1
Overall Study Withdrawn prior to any treatment	0	1

Baseline Characteristics

The Management of Closed Surgical Incisions Resulting From Incisional Hernia Repair and/or Functional Panniculectomy Using the Prevena™ Customizable™ Dressing

Baseline characteristics by cohort

Measure	Standard of Care n=34 Participants dry sterile dressing/gauze and steristrips Standard of Care Dressing	Customizable n=36 Participants Customizable Dressing with ActiV.A.C. Therapy Unit Customizable Dressing with ActiV.A.C. Therapy Unit	Total n=70 Participants Total of all reporting groups
Age, Continuous	43.2 years STANDARD_DEVIATION 7.79 • n=5 Participants	41.8 years STANDARD_DEVIATION 7.83 • n=7 Participants	42.5 years STANDARD_DEVIATION 7.78 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	34 Participants n=7 Participants	68 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	31 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	36 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 30 Days Post-Surgical Procedure

Population: Intent to Treat population

Surgical Site Complications:

• Dehiscence
• Surgical site infection (SSI)

Outcome measures

Measure	Standard of Care n=34 Participants dry sterile dressing/gauze and steristrips Standard of Care Dressing	Customizable n=35 Participants Customizable Dressing with ActiV.A.C. Therapy Unit Customizable Dressing with ActiV.A.C. Therapy Unit
Number of Participants With Surgical Site Complications	1 Participants	5 Participants

Adverse Events

Standard of Care

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Customizable

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard of Care n=34 participants at risk dry sterile dressing/gauze and steristrips Standard of Care Dressing	Customizable n=36 participants at risk Customizable Dressing with ActiV.A.C. Therapy Unit Customizable Dressing with ActiV.A.C. Therapy Unit
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/34 • 30 days Adverse Events were assessed at each protocol scheduled visit. The safety population had one subject less than the ITT population as they were randomized to Standard of Care yet a received Customizable dressing. The Customizable dressing was applied without any negative pressure.	5.6% 2/36 • 30 days Adverse Events were assessed at each protocol scheduled visit. The safety population had one subject less than the ITT population as they were randomized to Standard of Care yet a received Customizable dressing. The Customizable dressing was applied without any negative pressure.
Vascular disorders Shock haemorrhagic	0.00% 0/34 • 30 days Adverse Events were assessed at each protocol scheduled visit. The safety population had one subject less than the ITT population as they were randomized to Standard of Care yet a received Customizable dressing. The Customizable dressing was applied without any negative pressure.	2.8% 1/36 • 30 days Adverse Events were assessed at each protocol scheduled visit. The safety population had one subject less than the ITT population as they were randomized to Standard of Care yet a received Customizable dressing. The Customizable dressing was applied without any negative pressure.

Other adverse events

Measure	Standard of Care n=34 participants at risk dry sterile dressing/gauze and steristrips Standard of Care Dressing	Customizable n=36 participants at risk Customizable Dressing with ActiV.A.C. Therapy Unit Customizable Dressing with ActiV.A.C. Therapy Unit
Gastrointestinal disorders Abdominal discomfort	2.9% 1/34 • 30 days Adverse Events were assessed at each protocol scheduled visit. The safety population had one subject less than the ITT population as they were randomized to Standard of Care yet a received Customizable dressing. The Customizable dressing was applied without any negative pressure.	13.9% 5/36 • 30 days Adverse Events were assessed at each protocol scheduled visit. The safety population had one subject less than the ITT population as they were randomized to Standard of Care yet a received Customizable dressing. The Customizable dressing was applied without any negative pressure.
Gastrointestinal disorders Constipation	5.9% 2/34 • 30 days Adverse Events were assessed at each protocol scheduled visit. The safety population had one subject less than the ITT population as they were randomized to Standard of Care yet a received Customizable dressing. The Customizable dressing was applied without any negative pressure.	0.00% 0/36 • 30 days Adverse Events were assessed at each protocol scheduled visit. The safety population had one subject less than the ITT population as they were randomized to Standard of Care yet a received Customizable dressing. The Customizable dressing was applied without any negative pressure.
Injury, poisoning and procedural complications Wound dehiscence	2.9% 1/34 • 30 days Adverse Events were assessed at each protocol scheduled visit. The safety population had one subject less than the ITT population as they were randomized to Standard of Care yet a received Customizable dressing. The Customizable dressing was applied without any negative pressure.	8.3% 3/36 • 30 days Adverse Events were assessed at each protocol scheduled visit. The safety population had one subject less than the ITT population as they were randomized to Standard of Care yet a received Customizable dressing. The Customizable dressing was applied without any negative pressure.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/34 • 30 days Adverse Events were assessed at each protocol scheduled visit. The safety population had one subject less than the ITT population as they were randomized to Standard of Care yet a received Customizable dressing. The Customizable dressing was applied without any negative pressure.	5.6% 2/36 • 30 days Adverse Events were assessed at each protocol scheduled visit. The safety population had one subject less than the ITT population as they were randomized to Standard of Care yet a received Customizable dressing. The Customizable dressing was applied without any negative pressure.
Injury, poisoning and procedural complications Seroma	0.00% 0/34 • 30 days Adverse Events were assessed at each protocol scheduled visit. The safety population had one subject less than the ITT population as they were randomized to Standard of Care yet a received Customizable dressing. The Customizable dressing was applied without any negative pressure.	5.6% 2/36 • 30 days Adverse Events were assessed at each protocol scheduled visit. The safety population had one subject less than the ITT population as they were randomized to Standard of Care yet a received Customizable dressing. The Customizable dressing was applied without any negative pressure.
Infections and infestations Postoperative wound infection	0.00% 0/34 • 30 days Adverse Events were assessed at each protocol scheduled visit. The safety population had one subject less than the ITT population as they were randomized to Standard of Care yet a received Customizable dressing. The Customizable dressing was applied without any negative pressure.	13.9% 5/36 • 30 days Adverse Events were assessed at each protocol scheduled visit. The safety population had one subject less than the ITT population as they were randomized to Standard of Care yet a received Customizable dressing. The Customizable dressing was applied without any negative pressure.

Additional Information

Sr Director, Global Clinical Development

Acelity

Phone: 2102555595

Email: jane.hart@acelity.com

Results disclosure agreements

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

Restriction type: GT60