D-PLEX 310: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection

PHASE2CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

October 4, 2018

Primary Completion Date

September 6, 2019

Study Completion Date

October 6, 2019

Conditions
Abdominal SurgeryColon SurgeryPost-Op Infection
Interventions
DRUG

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).

OTHER

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"

Trial Locations (8)

Unknown

Wolfson MC, Holon

Meir MC, Kfar Saba

Rabin MC, Campus Beilinson, Petah Tikva

Sheba MC, Tel-Hashomer, Ramat Gan

Kaplan MC, Rehovot

Assuta Ramat-HaHayal, Tel Aviv

Tel-Aviv Sourasky MC, Tel Aviv

Assaf-Harofeh MC, Zrifin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PolyPid Ltd.

INDUSTRY