Trial Outcomes & Findings for D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery (NCT NCT03558984)

Results Overview

Sternal infection will be identified by predefined criteria based on modification of the CDC's Criteria for Surgical Site Infection (SSI) \& Surveillance Definition for Specific Types of Infections Chapters, January 2018

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

2 participants

Primary outcome timeframe

within 90 days (3 months) post sternotomy for cardiac surgery

Results posted on

2026-06-30

Participant Flow

The trial was early terminated after enrolment of two patients.

Participant milestones

Participant milestones
Measure	Other : Standard of Care For subjects randomized to the control arm, the surgical treatment will be per the SOC.	Experimental : D-PLEX + SOC For subjects randomized to the investigational treatment arm, D-PLEX treatment will be applied at the end of the index surgery just before closing the chest, as an adjunct to the SOC prophylactic antibiotic treatment.
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Other : Standard of Care n=1 Participants For subjects randomized to the control arm, the surgical treatment will be per SOC.	Experimental : D-PLEX + SOC n=1 Participants For subjects randomized to the investigational treatment arm, D-PLEX treatment will be applied at the end of the index surgery just before closing the chest, as an adjunct to the SOC prophylactic antibiotic treatment.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical >=65 years	1 Participants n=20 Participants	1 Participants n=20 Participants	2 Participants n=40 Participants
Sex/Gender, Customized Sex · Male	1 Participants n=20 Participants	1 Participants n=20 Participants	2 Participants n=40 Participants
Sex/Gender, Customized Sex · Female	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) White	1 Participants n=20 Participants	1 Participants n=20 Participants	2 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Region of Enrollment United States	1 Participants n=20 Participants	1 Participants n=20 Participants	2 Participants n=40 Participants

PRIMARY outcome

Timeframe: within 90 days (3 months) post sternotomy for cardiac surgery

Sternal infection will be identified by predefined criteria based on modification of the CDC's Criteria for Surgical Site Infection (SSI) \& Surveillance Definition for Specific Types of Infections Chapters, January 2018

Outcome measures

Outcome measures
Measure	Experimental : D-PLEX + SOC n=1 Participants For subjects randomized to the investigational treatment arm, D-PLEX treatment will be applied at the end of the index surgery just before closing the chest, as an adjunct to the SOC prophylactic antibiotic treatment.	Other : Standard of Care n=1 Participants For subjects randomized to the control arm, the surgical treatment will be per the SOC.
Number of Participants With a Sternal Wound Infection Event	0 Participants	0 Participants

SECONDARY outcome

Timeframe: within 90 days (3 months) post sternotomy for cardiac surgery

Population: Hospitalization duration per participant (days). Each arm includes one participant.

Number of Hospitalization days post sternotomy due to sternal infection.

Outcome measures

Outcome measures
Measure	Experimental : D-PLEX + SOC n=1 Participants For subjects randomized to the investigational treatment arm, D-PLEX treatment will be applied at the end of the index surgery just before closing the chest, as an adjunct to the SOC prophylactic antibiotic treatment.	Other : Standard of Care n=1 Participants For subjects randomized to the control arm, the surgical treatment will be per the SOC.
Hospitalization Days	5 Days	6 Days

SECONDARY outcome

Timeframe: 90 days (3 months) post sternotomy

Number of Surgical re-interventions due to sternal surgical site infection.

Outcome measures

Outcome measures
Measure	Experimental : D-PLEX + SOC n=1 Participants For subjects randomized to the investigational treatment arm, D-PLEX treatment will be applied at the end of the index surgery just before closing the chest, as an adjunct to the SOC prophylactic antibiotic treatment.	Other : Standard of Care n=1 Participants For subjects randomized to the control arm, the surgical treatment will be per the SOC.
Surgical Re-interventions	0 Number of events	0 Number of events

SECONDARY outcome

Timeframe: 90 days (3 month) post sternotomy

ASEPSIS is acronym of wound assessment and treatment parameters, which provides numerically score during an inspection of the surgical site. The final score is being interpreted to severity of wound appearance and the clinical consequences of the infection. Parameters and Scores: Serous discharge \& Erythema will be marked between 0 - 5. Purulent exudate \& Separation of deep tissue are marked between 0 - 10 - based on the proportion of the wound they affect when 0 is none and either 5 or 10 are for over 80% of the wound. Additional antibiotic treatment, a requirement for pus drainage, isolation of bacteria \& stay duration as an inpatient are scored Yes or No. No equals 0. Yes is calculated as either 5 points (for some parameters) or 10 for others. The final score can be in the range of 0 - 70. 0 - 10 for wound which heals satisfactorily and over 40 for a severe wound infection.

Outcome measures

Outcome measures
Measure	Experimental : D-PLEX + SOC n=1 Participants For subjects randomized to the investigational treatment arm, D-PLEX treatment will be applied at the end of the index surgery just before closing the chest, as an adjunct to the SOC prophylactic antibiotic treatment.	Other : Standard of Care n=1 Participants For subjects randomized to the control arm, the surgical treatment will be per the SOC.
ASEPSIS Assessment Score	0 score on a scale	0 score on a scale

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days (3 months)

Incidence of Superficial Sternal Wound Infections (SSWI) during 90 days post sternotomy will be analyzed using Fisher's Exact test similarly to the primary end point.

Outcome measures

Outcome measures
Measure	Experimental : D-PLEX + SOC n=1 Participants For subjects randomized to the investigational treatment arm, D-PLEX treatment will be applied at the end of the index surgery just before closing the chest, as an adjunct to the SOC prophylactic antibiotic treatment.	Other : Standard of Care n=1 Participants For subjects randomized to the control arm, the surgical treatment will be per the SOC.
Incidence of Superficial Sternal Wound Infections (SSWI)	0 Number of SSW infections	0 Number of SSW infections

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days (3 months) post sternotomy

Incidence of Deep Sternal Wound Infections (DSWI) during 90 days post sternotomy will be analyzed using Fisher's Exact test similarly to the primary end point.

Outcome measures

Outcome measures
Measure	Experimental : D-PLEX + SOC n=1 Participants For subjects randomized to the investigational treatment arm, D-PLEX treatment will be applied at the end of the index surgery just before closing the chest, as an adjunct to the SOC prophylactic antibiotic treatment.	Other : Standard of Care n=1 Participants For subjects randomized to the control arm, the surgical treatment will be per the SOC.
Incidence of Deep Sternal Wound Infection (DSWI)	0 Number of DSW infections	0 Number of DSW infections

OTHER_PRE_SPECIFIED outcome

Timeframe: within 90 days (3 month) post sternotomy

The analysis of Mortality rate associated with Sternal Wound Infection (SWI) within 90 days (3 months) post sternotomy will be analyzed using Fisher's Exact test similarly to the primary end point.

Outcome measures

Outcome measures
Measure	Experimental : D-PLEX + SOC n=1 Participants For subjects randomized to the investigational treatment arm, D-PLEX treatment will be applied at the end of the index surgery just before closing the chest, as an adjunct to the SOC prophylactic antibiotic treatment.	Other : Standard of Care n=1 Participants For subjects randomized to the control arm, the surgical treatment will be per the SOC.
Mortality Rate Associated With Sternal Wound Infection (SWI)	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 90 days post surgery

Determination of susceptibility to Doxycycline of any organism recovered from a Sternal Surgical Site Infection. The number of participants who have bacterial growth analyzed (if any).

Outcome measures

Outcome measures
Measure	Experimental : D-PLEX + SOC n=1 Participants For subjects randomized to the investigational treatment arm, D-PLEX treatment will be applied at the end of the index surgery just before closing the chest, as an adjunct to the SOC prophylactic antibiotic treatment.	Other : Standard of Care n=1 Participants For subjects randomized to the control arm, the surgical treatment will be per the SOC.
Susceptibility to Doxycycline	0 Participants	0 Participants

Adverse Events

D-PLEX + SOC

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	D-PLEX + SOC n=1 participants at risk For subjects randomized to the investigational treatment arm, D-PLEX treatment will be applied at the end of the index surgery just before closing the chest, as an adjunct to the SOC prophylactic antibiotic treatment.	Standard of Care n=1 participants at risk For subjects randomized to the control arm, the surgical treatment will be per SOC.
Metabolism and nutrition disorders HYPOKALEMIA	100.0% 1/1 • 6 months- from enrollment until last study visit	0.00% 0/1 • 6 months- from enrollment until last study visit

Other adverse events

Other adverse events
Measure	D-PLEX + SOC n=1 participants at risk For subjects randomized to the investigational treatment arm, D-PLEX treatment will be applied at the end of the index surgery just before closing the chest, as an adjunct to the SOC prophylactic antibiotic treatment.	Standard of Care n=1 participants at risk For subjects randomized to the control arm, the surgical treatment will be per SOC.
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/1 • 6 months- from enrollment until last study visit	100.0% 1/1 • 6 months- from enrollment until last study visit
Cardiac disorders Pericarditis	0.00% 0/1 • 6 months- from enrollment until last study visit	100.0% 1/1 • 6 months- from enrollment until last study visit
Blood and lymphatic system disorders Acute blood loss anemia	0.00% 0/1 • 6 months- from enrollment until last study visit	100.0% 1/1 • 6 months- from enrollment until last study visit
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/1 • 6 months- from enrollment until last study visit	100.0% 1/1 • 6 months- from enrollment until last study visit
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1 • 6 months- from enrollment until last study visit	100.0% 1/1 • 6 months- from enrollment until last study visit
Investigations Elevated ALT	0.00% 0/1 • 6 months- from enrollment until last study visit	100.0% 1/1 • 6 months- from enrollment until last study visit
Investigations Elevated AST	0.00% 0/1 • 6 months- from enrollment until last study visit	100.0% 1/1 • 6 months- from enrollment until last study visit
Psychiatric disorders Insomnia	0.00% 0/1 • 6 months- from enrollment until last study visit	100.0% 1/1 • 6 months- from enrollment until last study visit
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/1 • 6 months- from enrollment until last study visit	100.0% 1/1 • 6 months- from enrollment until last study visit
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/1 • 6 months- from enrollment until last study visit	100.0% 1/1 • 6 months- from enrollment until last study visit

Additional Information

Eyal Shoshani, VP Clinical Affairs

PolyPid

Phone: +972-74-7195700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place