Trial Outcomes & Findings for The Use of the Prevena Incision Management System (PIMS) on Closed Incisions in Renal Transplant Subjects (NCT NCT01341444)

Last Updated: 2024-10-16

Results Overview

The primary objective to compare short-term surgical incision-related clinical outcomes in Subjects undergoing open renal transplant surgery when treated with Prevena vs. the standard-of-care wound dressing. Clinical outcomes of interest are defined as Surgical Site Complications (SSCs) that include incisional fluid accumulation (i.e. seroma, hematoma, abscess), dehiscence, surgical site infection (SSI). These outcomes will be compared to a control group consisting of subjects screened for the same inclusion/exclusion criteria but treated with standard-of-care incision dressing.

Recruitment status

TERMINATED

Study phase

Target enrollment

63 participants

Primary outcome timeframe

62 Days

Results posted on

2024-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Prevena Incision Management System Negative Pressure Therapy Device Prevena Incision Management System: It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT).	Standard of Care for Surgical Incisions Sterile gauze and a non-penetrable barrier Standard of Care for Surgical Incisions: Sterile 4X4 Non-Penetrable barrier
Overall Study STARTED	31	32
Overall Study COMPLETED	26	29
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Use of the Prevena Incision Management System (PIMS) on Closed Incisions in Renal Transplant Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prevena Incision Management System n=31 Participants Negative Pressure Therapy Device Prevena Incision Management System: It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT).	Standard of Care for Surgical Incisions n=32 Participants Sterile gauze and a non-penetrable barrier Standard of Care for Surgical Incisions: Sterile 4X4 Non-Penetrable barrier	Total n=63 Participants Total of all reporting groups
Age, Continuous	48.71 years STANDARD_DEVIATION 11.29 • n=5 Participants	51.75 years STANDARD_DEVIATION 12.19 • n=7 Participants	50.25 years STANDARD_DEVIATION 11.76 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	27 Participants n=7 Participants	57 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	1 Participants n=5 Participants	2 Participants n=7 Participants	3 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	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	15 Participants n=7 Participants	27 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

PRIMARY outcome

Timeframe: 62 Days

Population: Analysis of this endpoint was based on the Full analysis Set (FAS population). The FAS population consists of participants who met all of the pre- and intra-operative eligibility criteria, were randomized and received treatment. Subjects without SSC must have received 5 days of Prevena or at least 3 days of SOC dressing and completed 30 day visit.

Outcome measures

Outcome measures
Measure	Prevena Incision Management System n=28 Participants Negative Pressure Therapy Device Prevena Incision Management System: It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT).	Standard of Care for Surgical Incisions n=30 Participants Sterile gauze and a non-penetrable barrier Standard of Care for Surgical Incisions: Sterile 4X4 Non-Penetrable barrier
Number of Participants With Surgical Site Complications (SSCs)	6 Participants	8 Participants

Adverse Events

Prevena Incision Management System

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care for Surgical Incisions

Serious events: 13 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Prevena Incision Management System n=31 participants at risk Negative Pressure Therapy Device Prevena Incision Management System: It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT).	Standard of Care for Surgical Incisions n=32 participants at risk Sterile gauze and a non-penetrable barrier Standard of Care for Surgical Incisions: Sterile 4X4 Non-Penetrable barrier
Injury, poisoning and procedural complications Wound Dehiscence	0.00% 0/31	6.2% 2/32
Cardiac disorders Atrial Fibrillation	0.00% 0/31	3.1% 1/32
Cardiac disorders Myocardial Infarction	3.2% 1/31	0.00% 0/32
General disorders Chest Pain	0.00% 0/31	3.1% 1/32
Immune system disorders Kidney Transplant Rejection	6.5% 2/31	0.00% 0/32
Infections and infestations Wound Infection	0.00% 0/31	3.1% 1/32
Injury, poisoning and procedural complications Ankle Fracture	3.2% 1/31	0.00% 0/32
Injury, poisoning and procedural complications Complications of Transplanted Kidney	3.2% 1/31	0.00% 0/32
Injury, poisoning and procedural complications Fall	0.00% 0/31	3.1% 1/32
Injury, poisoning and procedural complications Post Procedural Haemorrhage	3.2% 1/31	3.1% 1/32
Investigations Blood Creatine Increased	3.2% 1/31	3.1% 1/32
Investigations Urine Output Decreased	3.2% 1/31	0.00% 0/32
Metabolism and nutrition disorders Hypercreatininaemia	3.2% 1/31	9.4% 3/32
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/31	3.1% 1/32
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/31	3.1% 1/32
Nervous system disorders Cerebrovascular	0.00% 0/31	3.1% 1/32
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/31	3.1% 1/32
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.2% 1/31	0.00% 0/32
Surgical and medical procedures Incisional Drainage	0.00% 0/31	3.1% 1/32
Vascular disorders Ebolism	3.2% 1/31	0.00% 0/32
Vascular disorders Haematoma	6.5% 2/31	3.1% 1/32
Vascular disorders Haemorrhage	3.2% 1/31	3.1% 1/32

Other adverse events

Adverse event data not reported

Additional Information

Dr. Matthew Cooper

Medstar Georgetown University Hospital

Phone: 202-444-0753

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place