Trial Outcomes & Findings for D-PLEX 310: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (NCT NCT03633123)
NCT ID: NCT03633123
Last Updated: 2026-03-24
Results Overview
The infection rate and mortality rate were measured by the number and proportion of subjects with either an SSI event (as determined by the blinded and independent adjudication committee, within 30 days post abdominal surgery) or mortality for any reason within 30 days post index surgery
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
202 participants
Primary outcome timeframe
30 days post surgery
Results posted on
2026-03-24
Participant Flow
Subjects who met the eligibility requirements were randomized to either the investigational arm (SOC + D-PLEX) or the control arm (SOC only) in a 1:1 ratio. Subjects were randomized through an interactive web randomization system (IWRS) integrated with the electronic Case Report Form (eCRF), based on the subject's information collected during the screening period and details of the planned surgery.
Participant milestones
| Measure |
Standard of Care (SoC)
SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
D-PLEX + SoC
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
D\_PLEX: D\_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
101
|
|
Overall Study
Number of Subjects in the ITT Population
|
100
|
101
|
|
Overall Study
Actual Number of Subjects Treated in Each Treatment Group (Safety Population)
|
100
|
99
|
|
Overall Study
COMPLETED
|
93
|
100
|
|
Overall Study
NOT COMPLETED
|
8
|
1
|
Reasons for withdrawal
| Measure |
Standard of Care (SoC)
SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
D-PLEX + SoC
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
D\_PLEX: D\_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Death
|
5
|
0
|
|
Overall Study
Not willing to come to the hospital
|
1
|
1
|
|
Overall Study
The index surgery was not performed hence no abdominal incision
|
1
|
0
|
Baseline Characteristics
Demographic data is based on the safety population.
Baseline characteristics by cohort
| Measure |
Standard of Care (SoC)
n=100 Participants
SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: According to each participating center standard practice for this type of procedure
|
D-PLEX + SoC
n=101 Participants
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
D-PLEX: D-PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: According to each participating center standard practice for this type of procedure
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 16.28 • n=100 Participants • Demographic data is based on the safety population.
|
60.8 years
STANDARD_DEVIATION 15.27 • n=99 Participants • Demographic data is based on the safety population.
|
61.0 years
STANDARD_DEVIATION 15.74 • n=199 Participants • Demographic data is based on the safety population.
|
|
Sex: Female, Male
Female
|
39 Participants
n=100 Participants • Subjects demographic and other baseline characteristics were analyzed for the Safety population that includes 100 subjects in the SoC arm and 99 subjects in the D-PLEX + SOC arm
|
39 Participants
n=99 Participants • Subjects demographic and other baseline characteristics were analyzed for the Safety population that includes 100 subjects in the SoC arm and 99 subjects in the D-PLEX + SOC arm
|
78 Participants
n=199 Participants • Subjects demographic and other baseline characteristics were analyzed for the Safety population that includes 100 subjects in the SoC arm and 99 subjects in the D-PLEX + SOC arm
|
|
Sex: Female, Male
Male
|
61 Participants
n=100 Participants • Subjects demographic and other baseline characteristics were analyzed for the Safety population that includes 100 subjects in the SoC arm and 99 subjects in the D-PLEX + SOC arm
|
60 Participants
n=99 Participants • Subjects demographic and other baseline characteristics were analyzed for the Safety population that includes 100 subjects in the SoC arm and 99 subjects in the D-PLEX + SOC arm
|
121 Participants
n=199 Participants • Subjects demographic and other baseline characteristics were analyzed for the Safety population that includes 100 subjects in the SoC arm and 99 subjects in the D-PLEX + SOC arm
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=100 Participants • Demographic data is based on safety population only
|
0 Participants
n=99 Participants • Demographic data is based on safety population only
|
0 Participants
n=199 Participants • Demographic data is based on safety population only
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=100 Participants • Demographic data is based on safety population only
|
0 Participants
n=99 Participants • Demographic data is based on safety population only
|
1 Participants
n=199 Participants • Demographic data is based on safety population only
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=100 Participants • Demographic data is based on safety population only
|
0 Participants
n=99 Participants • Demographic data is based on safety population only
|
0 Participants
n=199 Participants • Demographic data is based on safety population only
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=100 Participants • Demographic data is based on safety population only
|
0 Participants
n=99 Participants • Demographic data is based on safety population only
|
0 Participants
n=199 Participants • Demographic data is based on safety population only
|
|
Race (NIH/OMB)
White
|
99 Participants
n=100 Participants • Demographic data is based on safety population only
|
99 Participants
n=99 Participants • Demographic data is based on safety population only
|
198 Participants
n=199 Participants • Demographic data is based on safety population only
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=100 Participants • Demographic data is based on safety population only
|
0 Participants
n=99 Participants • Demographic data is based on safety population only
|
0 Participants
n=199 Participants • Demographic data is based on safety population only
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=100 Participants • Demographic data is based on safety population only
|
0 Participants
n=99 Participants • Demographic data is based on safety population only
|
0 Participants
n=199 Participants • Demographic data is based on safety population only
|
|
BMI
|
27.47 kg/m^2
STANDARD_DEVIATION 5.27 • n=100 Participants • Subjects demographics and other baseline characteristics were analyzed for the Safety population that includes 100 subjects in the SoC arm and 99 subjects in the D-PLEX + SOC arm
|
26.72 kg/m^2
STANDARD_DEVIATION 5.16 • n=99 Participants • Subjects demographics and other baseline characteristics were analyzed for the Safety population that includes 100 subjects in the SoC arm and 99 subjects in the D-PLEX + SOC arm
|
27.09 kg/m^2
STANDARD_DEVIATION 5.22 • n=199 Participants • Subjects demographics and other baseline characteristics were analyzed for the Safety population that includes 100 subjects in the SoC arm and 99 subjects in the D-PLEX + SOC arm
|
|
Height
|
170.24 cm
STANDARD_DEVIATION 9.12 • n=100 Participants • Subjects demographic and other baseline characteristics were analyzed for the Safety population that includes 100 subjects in the SoC arm and 99 subjects in the D-PLEX + SOC arm
|
168.33 cm
STANDARD_DEVIATION 9.93 • n=99 Participants • Subjects demographic and other baseline characteristics were analyzed for the Safety population that includes 100 subjects in the SoC arm and 99 subjects in the D-PLEX + SOC arm
|
169.29 cm
STANDARD_DEVIATION 9.55 • n=199 Participants • Subjects demographic and other baseline characteristics were analyzed for the Safety population that includes 100 subjects in the SoC arm and 99 subjects in the D-PLEX + SOC arm
|
|
Weight
|
80.2 kg
STANDARD_DEVIATION 18.66 • n=100 Participants • Subjects demographic other baseline characteristics were analysed for the Safety population that includes 100 subjects in the SoC arm and 99 subjects in the D-PLEX + SOC arm
|
75.78 kg
STANDARD_DEVIATION 16.07 • n=99 Participants • Subjects demographic other baseline characteristics were analysed for the Safety population that includes 100 subjects in the SoC arm and 99 subjects in the D-PLEX + SOC arm
|
77.91 kg
STANDARD_DEVIATION 17.51 • n=199 Participants • Subjects demographic other baseline characteristics were analysed for the Safety population that includes 100 subjects in the SoC arm and 99 subjects in the D-PLEX + SOC arm
|
PRIMARY outcome
Timeframe: 30 days post surgeryPopulation: Intent to Treat (ITT) population.
The infection rate and mortality rate were measured by the number and proportion of subjects with either an SSI event (as determined by the blinded and independent adjudication committee, within 30 days post abdominal surgery) or mortality for any reason within 30 days post index surgery
Outcome measures
| Measure |
Standard of Care (SoC)
n=100 Participants
SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
D-PLEX + SoC
n=101 Participants
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
D\_PLEX: D\_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
|---|---|---|
|
The Combined Infection and Mortality Rate Within 30 Days Post Index Surgery
|
24 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 30 days post surgeryPopulation: ITT population
ASEPSIS is acronym of wound assessment and treatment parameters (described in the title), 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. Each parameter will be evaluated and numerically scored. Some (Serous discharge \& Erythema) will be marked between 0 - 5 and others (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. Other parameters (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
| Measure |
Standard of Care (SoC)
n=100 Participants
SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
D-PLEX + SoC
n=101 Participants
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
D\_PLEX: D\_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
|---|---|---|
|
Average ASEPSIS Assessment Score (for Parameters Additional Treatment, Serous Discharge, Erythema, Purulent Exudate, Separation of Deep Tissue, Isolation of Bacteria, Stay Duration as Inpatient) During 30 Days Post-surgery.
|
1.37 score on a scale
Standard Deviation 4.72
|
0.77 score on a scale
Standard Deviation 3.32
|
SECONDARY outcome
Timeframe: 30 days post surgeryPopulation: ITT population
Death from any reason within 30 days post abdominal surgery
Outcome measures
| Measure |
Standard of Care (SoC)
n=100 Participants
SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
D-PLEX + SoC
n=101 Participants
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
D\_PLEX: D\_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
|---|---|---|
|
Mortality Rate Within 30 Days Post Abdominal Surgery
|
3 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days post-surgeryPopulation: ITT population
The number and proportion of subjects who experienced Surgical site infection (SSI) within 30 days
Outcome measures
| Measure |
Standard of Care (SoC)
n=100 Participants
SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
D-PLEX + SoC
n=101 Participants
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
D\_PLEX: D\_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
|---|---|---|
|
Infection Rate
|
21 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days post surgeryPopulation: ITT population
The number and proportion of subjects who experienced at least one SSSI within 30 days post abdominal surgery were presented by treatment.
Outcome measures
| Measure |
Standard of Care (SoC)
n=100 Participants
SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
D-PLEX + SoC
n=101 Participants
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
D\_PLEX: D\_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
|---|---|---|
|
Incidence of Superficial Surgical Site Infection (SSSI) During 30 Days Post-surgery
|
19 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days post surgeryPopulation: ITT population
The number and proportion of subjects who experienced at least one DSSI within 30 days post abdominal surgery were presented by treatment.
Outcome measures
| Measure |
Standard of Care (SoC)
n=100 Participants
SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
D-PLEX + SoC
n=101 Participants
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
D\_PLEX: D\_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
|---|---|---|
|
Incidence of Deep Surgical Site Infection (DSSI) During 30 Days Post-surgery
|
2 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During 60 days of study participationPopulation: ITT population
Death from any reason within 60 days post abdominal surgery
Outcome measures
| Measure |
Standard of Care (SoC)
n=100 Participants
SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
D-PLEX + SoC
n=101 Participants
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
D\_PLEX: D\_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
|---|---|---|
|
Mortality Rate Within 60 Days Post Abdominal Surgery
|
5 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During 60 days of study participationPopulation: ITT population
Number of hospitalization days after surgery and until discharge. Will include prolongation of primary hospitalization compared to the average of the rest of the recruited patients and re-admission due to infection
Outcome measures
| Measure |
Standard of Care (SoC)
n=100 Participants
SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
D-PLEX + SoC
n=101 Participants
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
D\_PLEX: D\_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
|---|---|---|
|
Number of Overall Hospitalization Days Post Surgery
|
9.39 Days
Standard Deviation 5.46
|
10.02 Days
Standard Deviation 6.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days post-surgeryPopulation: ITT population
The number and proportion of subjects hospitalized due to SSI within 30 days post-surgery
Outcome measures
| Measure |
Standard of Care (SoC)
n=100 Participants
SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
D-PLEX + SoC
n=101 Participants
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
D\_PLEX: D\_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
|---|---|---|
|
Subject Hospitalization Due to SSI
|
2 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days post surgeryPopulation: ITT population
Resistance to Doxycycline for any organisms recovered from an abdominal surgery incisional Infection site will be done using a central lab. Any organism which will grow (if), will be further tested for Doxycycline susceptibility. The number of participants who have bacterial growth analyzed was summarized by treatment group.
Outcome measures
| Measure |
Standard of Care (SoC)
n=100 Participants
SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
D-PLEX + SoC
n=101 Participants
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
D\_PLEX: D\_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
|---|---|---|
|
Susceptibility to Doxycycline
|
6 participants
|
8 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During 30 days of study participationPopulation: ITT population
The number and proportion of subjects with hospital re-admission due to SSI.
Outcome measures
| Measure |
Standard of Care (SoC)
n=100 Participants
SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
D-PLEX + SoC
n=101 Participants
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
D\_PLEX: D\_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
|---|---|---|
|
Number of Re-admissions Due to Surgical Site Infection
|
2 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 60 days post surgeryPopulation: ITT population
The number of antibiotic treatment days due to SSI.
Outcome measures
| Measure |
Standard of Care (SoC)
n=100 Participants
SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
D-PLEX + SoC
n=101 Participants
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
D\_PLEX: D\_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
|---|---|---|
|
Number of Antibiotic Treatment Days Post Surgery
|
5.81 Days
Standard Deviation 5.61
|
4.33 Days
Standard Deviation 3.50
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 60 days post-surgeryPopulation: The number of ITT population subjects who experienced at least one adjudicated SSI
The number and proportion of subjects who received antibiotics due to SSI
Outcome measures
| Measure |
Standard of Care (SoC)
n=21 Participants
SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
D-PLEX + SoC
n=10 Participants
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
D\_PLEX: D\_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
|---|---|---|
|
Subjects Receiving Antibiotics Due to SSI
|
7 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days post surgeryPopulation: The number of ITT population subjects who experienced at least one adjudicated SSI
Number of days between surgery and a confirmed incisional surgery infection
Outcome measures
| Measure |
Standard of Care (SoC)
n=21 Participants
SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
D-PLEX + SoC
n=10 Participants
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
D\_PLEX: D\_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
|---|---|---|
|
Time to Surgical Site Infection
|
9.1 Days
Standard Deviation 0.91
|
16.3 Days
Standard Deviation 3.59
|
Adverse Events
Standard of Care (SoC)
Serious events: 20 serious events
Other events: 52 other events
Deaths: 5 deaths
D-PLEX + SoC
Serious events: 16 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard of Care (SoC)
n=100 participants at risk
SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
D-PLEX + SoC
n=99 participants at risk
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
D-PLEX: D-PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Duodenal perforation
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Haematochezia
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Ileus
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
2.0%
2/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Internal hernia
|
0.00%
0/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
1.0%
1/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
1.0%
1/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
2.0%
2/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
General disorders
Asthenia
|
0.00%
0/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
1.0%
1/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
General disorders
Death
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
General disorders
General physical health deterioration
|
0.00%
0/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
1.0%
1/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Infections and infestations
Abdominal abscess
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Infections and infestations
Peritoneal abscess
|
0.00%
0/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
1.0%
1/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Infections and infestations
Peritonitis
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Infections and infestations
Pneumonia
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Infections and infestations
Postoperative wound infection
|
2.0%
2/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
1.0%
1/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Infections and infestations
Sepsis
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Infections and infestations
Septic shock
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Injury, poisoning and procedural complications
Anastomotic haemorrhage
|
0.00%
0/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
1.0%
1/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
3.0%
3/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
2.0%
2/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Injury, poisoning and procedural complications
Injury
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
1.0%
1/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
1.0%
1/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Injury, poisoning and procedural complications
Ureteric injury
|
0.00%
0/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
1.0%
1/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Renal and urinary disorders
Renal failure
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
1.0%
1/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Renal and urinary disorders
Urinary retention
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
1.0%
1/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Renal and urinary disorders
Vesicocutaneous fistula
|
0.00%
0/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
1.0%
1/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
1.0%
1/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
1.0%
1/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
Other adverse events
| Measure |
Standard of Care (SoC)
n=100 participants at risk
SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
D-PLEX + SoC
n=99 participants at risk
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
D-PLEX: D-PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).
Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
Post-operation: this is each participating center standard practice for this type of procedure
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
3/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
3.0%
3/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Ileus
|
6.0%
6/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
8.1%
8/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
General disorders
Impaired healing
|
4.0%
4/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
4.0%
4/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Infections and infestations
Postoperative wound infection
|
23.0%
23/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
15.2%
15/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Infections and infestations
Urinary tract infection
|
3.0%
3/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
7.1%
7/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
5.0%
5/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
3.0%
3/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
2.0%
2/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
2/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
0.00%
0/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
2.0%
2/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
2/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
1.0%
1/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
General disorders
Pyrexia
|
2.0%
2/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
1.0%
1/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
2.0%
2/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.00%
0/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
2.0%
2/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/100 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
2.0%
2/99 • 2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place