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Antimicrobial

D-PLEX for Surgical Site Infection (D-PLEX312 Trial)

Phase 3

Recruiting

Research Sponsored by PolyPid Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects are preoperative hemodynamically stable (BP≤180/110 and >90/60 mmHg, and HR≤120 and >60 bpm, and temperature ≤37.50C and >35.50C)

Subjects' age 18 years old and above at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at study visits: day 1, day 5, day 14 and day 30 post surgery

Awards & highlights

D-PLEX312 Trial Summary

This trial will compare the efficacy and safety of D-PLEX to the standard of care in preventing post-operative abdominal infection.

Who is the study for?

Adults over 18, undergoing elective colorectal surgery with a large incision, who are stable before the operation and expected to live at least 60 days after. Women must not be pregnant and agree to birth control. Excludes those with recent abdominal surgeries or infections, severe allergies, liver/kidney issues, or active cancer treatments.Check my eligibility

What is being tested?

This Phase III trial is testing D-PLEX's safety and effectiveness in preventing infection after abdominal surgery compared to standard care alone. Participants will be randomly assigned to receive either D-PLEX plus standard care or just standard care in a double-blind setup.See study design

What are the potential side effects?

Potential side effects of D-PLEX may include reactions related to its components like doxycycline allergy symptoms but specific side effect profiles will be monitored as part of the study's safety assessment.

D-PLEX312 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood pressure, heart rate, and temperature are within safe ranges.

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I am 18 years old or older.

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I am having colorectal surgery with a large cut.

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My blood pressure and heart rate are stable before surgery.

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I am 18 years old or older.

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I am a man or a woman not currently pregnant.

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I am having surgery for my colon or rectum that involves a large cut.

D-PLEX312 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at study visits: day 1, day 5, day 14 and day 30 post surgery

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

Safety of D-PLEX in Prevention of Post Abdominal Surgery

Safety of D-PLEX in Prevention of Post Abdominal Surgery Incisional

Communicable Diseases

Secondary outcome measures

Assessment of Infection rate in patient undergoing abdominal colon surgery

D-PLEX312 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 Treatment2 Interventions

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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

PolyPid Ltd.Lead Sponsor

6 Previous Clinical Trials

1,310 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being accepted into this clinical trial?

"The listed clinical trial is currently recruiting patients. According to the information on clinicaltrials.gov, which was last updated on October 25th, 2022, 900 individuals are needed from 3 different study sites."

Answered by AI

Is D-PLEX a reliable treatment option for patients?

"D-PLEX received a safety score of 3 from our team at Power. This is due to the fact that D-PLEX is in Phase 3 trials, which implies that there is both efficacy and safety data supporting its use."

Answered by AI

Does the age limit for this research project allow for senior citizens?

"This research is looking for participants who are at least 18 and younger than 99."

Answered by AI

How do I sign-up for the clinical study?

"This study is looking for 900 patients, who currently have surgical wound infection and meet the following criteria: Subjects are preoperative hemodynamically stable., Male or non-pregnant female., Female of child-bearing potential should have a negative pregnancy test prior to index procedure., Subjects' age 18 years old and above at screening., Subjects who sign the written Informed Consent Form., Subjects who are willing and able to participate and meet all study requirements., Survival expectancy of at least 60 days post randomization ., Subjects undergoing an elective colorectal surgery involving resection, with or without a stoma formation, that includes at least"

Answered by AI

How many individuals are part of this research initiative?

"Yes, as of right now the trial is still looking for participants. According to the listing on clinicaltrials.gov, recruitment started on December 6th 2020 and will continue until 900 patients have been enrolled from 3 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)

2020. "D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04411199.