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Antimicrobial

D-PLEX+SoC for Surgical Site Infection

Phase 3
Waitlist Available
Research Sponsored by PolyPid Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at study visits: day 1, day 5, day 14 and day 30 post surgery
Awards & highlights

Study Summary

This trial will compare the efficacy and safety of a new treatment (D-PLEX) to the current standard of care (SoC) in preventing post-abdominal surgery incisional infections.

Eligible Conditions
  • Surgical Site Infection
  • Colon Surgery
  • Abdominal Surgery
  • Infections

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study visits: day 1, day 5, day 14 and day 30 post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and at study visits: day 1, day 5, day 14 and day 30 post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To assess the anti-infective efficacy of D-PLEX over a period of 30 days post operation, by preventing surgical site infection (SSI), defined as superficial and deep infection, in the target incision(s), compared to the SoC treated control.
Secondary outcome measures
Assessment of Infection rate in patient undergoing abdominal colon surgery
Other outcome measures
All-cause mortality and re-interventions in the target incision due to SSI
Assess Safety of D-PLEX in Prevention of Post Abdominal Surgery Incisional

Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard of careExperimental Treatment1 Intervention
The SoC for prophylactic antibiotic treatment is based on international guidelines
Group II: D-PLEX+SoCExperimental Treatment1 Intervention
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
D-PLEX
2016
Completed Phase 3
~1030

Find a Location

Who is running the clinical trial?

PolyPid Ltd.Lead Sponsor
6 Previous Clinical Trials
984 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
2020. "D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04233424.
~197 spots leftby Apr 2025
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