Trial Outcomes & Findings for The Effect of Irrisept for Irrigation of Skin and Soft Tissue Infections (Irrisept USF Study) (NCT NCT01076049)

Last Updated: 2021-08-23

Results Overview

The primary endpoint was overall wound progression and signs of infection 48 hours post-treatment. This was measured via a blinded investigator's discretion and recorded as 'improved', 'no change', 'progression of signs or symptoms of infection', or 'immediate treatment required' if an infection had progressed to a certain extent.

Recruitment status

TERMINATED

Study phase

Target enrollment

114 participants

Primary outcome timeframe

48 hours

Results posted on

2021-08-23

Participant Flow

From January 2010 to December 2011, patients with skin and soft tissue infections were recruited from the Tampa General Hospital, University of South Florida emergency department.

A total of 114 subjects consented to the study. Of these, 107 subjects were randomized as six (6) failed screening and one (1) subject had no randomization information available, but still completed the study. In total, 98 subjects completed the study. Of those 98 subjects, 52 subjects were enrolled in the Irrisept arm and 45 subjects were enrolled in the SoC control arm. There are records of an additional subject completing the study, but no randomization information was available.

Participant milestones

Participant milestones
Measure	Standard of Care (SoC) The type of irrigation solution and method used as SoC was determined by the participating emergency department physician. The SoC method was used at the initial and 48-hour follow-up visit.	Irrisept Delivery System Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits. Irrisept is a manual, self-contained irrigation device capable of producing 7-8 psi of pressure for effective wound cleansing and irrigation. Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The bottle design allows users to control the pressure of the solution through manual bottle compression.	Randomization Unknown The randomization group (SoC or Irrisept) is unknown for 1 subject.
Overall Study STARTED	52	55	1
Overall Study COMPLETED	45	52	1
Overall Study NOT COMPLETED	7	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Irrisept for Irrigation of Skin and Soft Tissue Infections (Irrisept USF Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care (SoC) n=45 Participants For subjects randomized to the control group, the preferred irrigation solution was chosen by the site's emergency department physician(s). Standard of Care (SoC): The preferred irrigation solution and method was chosen by the site's emergency department physician(s) and could vary between subjects. The type of SoC was recorded in the source document and the same solution and irrigation method were used during the initial treatment and 48-hour follow-up visits.	Irrisept Device System n=52 Participants For subjects randomized to the investigational group, Irrisept was used. Irrisept Delivery System: Irrisept is a manual, self-contained irrigation device capable of producing 7-8 psi of pressure for effective wound cleansing and irrigation. Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The bottle design allows users to control the pressure of the solution through manual bottle compression. Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits.	Randomization Unknown n=1 Participants	Total n=98 Participants Total of all reporting groups
Race/Ethnicity, Customized Unknown Race/Ethnicity	1 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	3 Participants n=483 Participants
Region of Enrollment United States	45 Participants n=93 Participants	52 Participants n=4 Participants	1 Participants n=27 Participants	98 Participants n=483 Participants
Age, Customized Subject Accounting	45 Participants n=93 Participants	52 Participants n=4 Participants	1 Participants n=27 Participants	98 Participants n=483 Participants
Sex/Gender, Customized Gender · Female	25 Participants n=93 Participants	27 Participants n=4 Participants	0 Participants n=27 Participants	52 Participants n=483 Participants
Sex/Gender, Customized Gender · Male	19 Participants n=93 Participants	25 Participants n=4 Participants	1 Participants n=27 Participants	45 Participants n=483 Participants
Sex/Gender, Customized Gender · Unknown Gender	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race/Ethnicity, Customized Race (Black)	15 Participants n=93 Participants	25 Participants n=4 Participants	0 Participants n=27 Participants	40 Participants n=483 Participants
Race/Ethnicity, Customized Race (White)	23 Participants n=93 Participants	18 Participants n=4 Participants	1 Participants n=27 Participants	42 Participants n=483 Participants
Race/Ethnicity, Customized Ethnicity (Hispanic)	6 Participants n=93 Participants	7 Participants n=4 Participants	0 Participants n=27 Participants	13 Participants n=483 Participants

PRIMARY outcome

Timeframe: 48 hours

Outcome measures

Outcome measures
Measure	Standard of Care (SoC) n=45 Participants For subjects randomized to the control group, the preferred irrigation solution was chosen by the site's emergency department physician(s). Standard of Care (SoC): The preferred irrigation solution and method was chosen by the site's emergency department physician(s) and could vary between subjects. The type of SoC was recorded in the source document and the same solution and irrigation method were used during the initial treatment and 48-hour follow-up visits.	Irrisept Device System n=52 Participants For subjects randomized to the investigational group, Irrisept was used. Irrisept Delivery System: Irrisept is a manual, self-contained irrigation device capable of producing 7-8 psi of pressure for effective wound cleansing and irrigation. Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The bottle design allows users to control the pressure of the solution through manual bottle compression. Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits.	Randomization Unknown n=1 Participants
Wound State at 48-Hour Follow-up Visit Improved Wound State at 48-Hour Follow-up	40 Participants	47 Participants	0 Participants
Wound State at 48-Hour Follow-up Visit No Change Wound State at 48-Hour Follow-up	1 Participants	1 Participants	0 Participants
Wound State at 48-Hour Follow-up Visit Progression Wound State at 48-Hour Follow-up	3 Participants	2 Participants	0 Participants
Wound State at 48-Hour Follow-up Visit Immediate Treatment Required Wound State at 48-Hour Follow-up	1 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 48 hours

Population: There were 45 SoC \& 52 Irrisept subjects that completed the trial. Of these, 20 SoC \& 16 Irrisept subjects showed clinical signs of infection worsening; 25 SoC \& 36 Irrisept subjects did not show infection worsening signs. Worsening signs include changes in length, width, erythema, area, induration tenderness, warmth, pain, cellulitis and other. The total number of worsening signs for SoC subjects was 32. The total number of worsening signs for Irrisept subjects was 28.

The study tracked any instance of a subject's conditions worsening compared to their baseline measurements. This included a worsening in the size (length and width) and clinical signs (erythema, area, induration, tenderness, warm, pain, cellulitis and other) of the infection. While the protocol states the overall prevalence of Methicillin-resistant Staphylococcus Aureus (MRSA) colonization is the secondary objective, this information was not collected by the site. Therefore, worsening of clinical outcomes is considered the secondary objective.

Outcome measures

Outcome measures
Measure	Standard of Care (SoC) n=32 Total Number of Worsening Outcomes For subjects randomized to the control group, the preferred irrigation solution was chosen by the site's emergency department physician(s). Standard of Care (SoC): The preferred irrigation solution and method was chosen by the site's emergency department physician(s) and could vary between subjects. The type of SoC was recorded in the source document and the same solution and irrigation method were used during the initial treatment and 48-hour follow-up visits.	Irrisept Device System n=28 Total Number of Worsening Outcomes For subjects randomized to the investigational group, Irrisept was used. Irrisept Delivery System: Irrisept is a manual, self-contained irrigation device capable of producing 7-8 psi of pressure for effective wound cleansing and irrigation. Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The bottle design allows users to control the pressure of the solution through manual bottle compression. Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits.	Randomization Unknown n=1 Total Number of Worsening Outcomes
Clinical Performance of Irrisept to the Current SoC Increased Length (cm)	5 Total Number of Worsening Outcomes	9 Total Number of Worsening Outcomes	0 Total Number of Worsening Outcomes
Clinical Performance of Irrisept to the Current SoC Increased Width (cm)	3 Total Number of Worsening Outcomes	5 Total Number of Worsening Outcomes	1 Total Number of Worsening Outcomes
Clinical Performance of Irrisept to the Current SoC Erythema	4 Total Number of Worsening Outcomes	0 Total Number of Worsening Outcomes	0 Total Number of Worsening Outcomes
Clinical Performance of Irrisept to the Current SoC Area (cm2)	1 Total Number of Worsening Outcomes	3 Total Number of Worsening Outcomes	0 Total Number of Worsening Outcomes
Clinical Performance of Irrisept to the Current SoC Induration	6 Total Number of Worsening Outcomes	2 Total Number of Worsening Outcomes	0 Total Number of Worsening Outcomes
Clinical Performance of Irrisept to the Current SoC Tenderness	2 Total Number of Worsening Outcomes	2 Total Number of Worsening Outcomes	0 Total Number of Worsening Outcomes
Clinical Performance of Irrisept to the Current SoC Warmth	6 Total Number of Worsening Outcomes	3 Total Number of Worsening Outcomes	0 Total Number of Worsening Outcomes
Clinical Performance of Irrisept to the Current SoC Pain	3 Total Number of Worsening Outcomes	3 Total Number of Worsening Outcomes	0 Total Number of Worsening Outcomes
Clinical Performance of Irrisept to the Current SoC Cellulitis	0 Total Number of Worsening Outcomes	0 Total Number of Worsening Outcomes	0 Total Number of Worsening Outcomes
Clinical Performance of Irrisept to the Current SoC Other	2 Total Number of Worsening Outcomes	1 Total Number of Worsening Outcomes	0 Total Number of Worsening Outcomes
Clinical Performance of Irrisept to the Current SoC No Signs of Infection Worsening	25 Total Number of Worsening Outcomes	36 Total Number of Worsening Outcomes	0 Total Number of Worsening Outcomes

POST_HOC outcome

Timeframe: 48 Hours

Population: Causality assessment categories for each worsening sign were related, possibly related, unlikely related, or unrelated. 45 SoC and 52 Irrisept subjects completed the trial. Of these, 20 SoC \& 16 Irrisept subjects showed clinical signs of worsening; causality assessments were made for each worsening sign (ex: length, erythema, etc.). There were 32 and 28 total worsening signs for SoC \& Irrisept subjects, respectively.

Causality for each worsening event was determined by using the following categories: 'related', 'possibly related', 'unlikely related', or 'unrelated'.

Outcome measures

Outcome measures
Measure	Standard of Care (SoC) n=32 Total Number of Worsening Outcomes For subjects randomized to the control group, the preferred irrigation solution was chosen by the site's emergency department physician(s). Standard of Care (SoC): The preferred irrigation solution and method was chosen by the site's emergency department physician(s) and could vary between subjects. The type of SoC was recorded in the source document and the same solution and irrigation method were used during the initial treatment and 48-hour follow-up visits.	Irrisept Device System n=28 Total Number of Worsening Outcomes For subjects randomized to the investigational group, Irrisept was used. Irrisept Delivery System: Irrisept is a manual, self-contained irrigation device capable of producing 7-8 psi of pressure for effective wound cleansing and irrigation. Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The bottle design allows users to control the pressure of the solution through manual bottle compression. Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits.	Randomization Unknown n=1 Total Number of Worsening Outcomes
Worsening Events Causality Related Worsening Event	0 Total Number of Worsening Outcomes	0 Total Number of Worsening Outcomes	0 Total Number of Worsening Outcomes
Worsening Events Causality Possibly Related Worsening Event	0 Total Number of Worsening Outcomes	0 Total Number of Worsening Outcomes	0 Total Number of Worsening Outcomes
Worsening Events Causality Unlikely Related Worsening Event	28 Total Number of Worsening Outcomes	26 Total Number of Worsening Outcomes	0 Total Number of Worsening Outcomes
Worsening Events Causality Unrelated Worsening Event	4 Total Number of Worsening Outcomes	2 Total Number of Worsening Outcomes	1 Total Number of Worsening Outcomes

Adverse Events

Standard of Care (SoC)

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Irrisept Delivery System

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Randomization Unknown

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Standard of Care (SoC) n=45 participants at risk The type of irrigation solution and method used as SoC was determined by the participating emergency department physician. The SoC method was used at the initial and 48-hour follow-up visit.	Irrisept Delivery System n=52 participants at risk Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits. Irrisept is a manual, self-contained irrigation device capable of producing 7-8 psi of pressure for effective wound cleansing and irrigation. Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The bottle design allows users to control the pressure of the solution through manual bottle compression.	Randomization Unknown n=1 participants at risk There are records of an additional subject completing the study, but no randomization information was available.
Infections and infestations Increased Length	11.1% 5/45 • Number of events 5 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.	17.3% 9/52 • Number of events 9 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.	0.00% 0/1 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.
Infections and infestations Increased Width	6.7% 3/45 • Number of events 3 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.	9.6% 5/52 • Number of events 5 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.	100.0% 1/1 • Number of events 1 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.
Infections and infestations Erythema	8.9% 4/45 • Number of events 4 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.	0.00% 0/52 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.	0.00% 0/1 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.
Infections and infestations Area	2.2% 1/45 • Number of events 1 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.	5.8% 3/52 • Number of events 3 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.	0.00% 0/1 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.
Infections and infestations Induration	13.3% 6/45 • Number of events 6 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.	3.8% 2/52 • Number of events 2 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.	0.00% 0/1 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.
Infections and infestations Tenderness	4.4% 2/45 • Number of events 2 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.	3.8% 2/52 • Number of events 2 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.	0.00% 0/1 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.
Infections and infestations Warmth	13.3% 6/45 • Number of events 6 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.	5.8% 3/52 • Number of events 3 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.	0.00% 0/1 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.
Infections and infestations Pain	6.7% 3/45 • Number of events 3 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.	5.8% 3/52 • Number of events 3 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.	0.00% 0/1 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.
Infections and infestations Cellulitis	0.00% 0/45 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.	0.00% 0/52 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.	0.00% 0/1 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.
Infections and infestations Other	4.4% 2/45 • Number of events 2 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.	1.9% 1/52 • Number of events 1 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.	0.00% 0/1 • The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit). Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.

Additional Information

Chevy Brown, Clinical Trials Manager

Irrimax Corporation

Phone: 770-807-3355

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place