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

March 23, 2026 updated by: PolyPid Ltd.

Phase II, Multicentre, Randomized, Controlled, Two Arm, Single Blind Study to Assess Safety and Efficacy of D-PLEX Administered Concomitantly With SOC, Compared to SOC, in Prevention of Post Abdominal Surgery Incisional Infection.

Subjects who are planned to undergo an abdominal (colon) surgery and who will meet the study entry criteria will be randomly divided into 2 groups: for half D-PLEX will be administered concomitantly with the standard of care (SOC). The other half will receive the Standard of Care treatment.

Following the surgery subjects will be followed up for additional 5 visits, at least half are in line with the routine practice of surgery Follow-Ups.

Visits will include patient safety and wound assessments.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

D-PLEX is a new formulation of extended controlled release of Doxycycline in the applied area for about 30 days. This study is aimed to assess the safety and efficacy of D-PLEX in prevention of post abdominal surgery incisional infection.

Eligible and willing subjects will be randomly divided, in a single-blinded manner into 2 study arms D-PLEX with SOC or SOC alone. D-PLEX will be applied during the surgery at the final stage of incision closure. All patients will be followed up for additional 5 visits over 2 months, for safety and incisional wound assessment. This will include blood tests for hematology, chemistry and pharmacokinetics (PK, for some only) as well as physicians assessment of the incisional wound.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
202

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Holon, Israel
        • Wolfson MC
      • Kfar Saba, Israel
        • Meir MC
      • Petah Tikva, Israel
        • Rabin MC, Campus Beilinson
      • Ramat Gan, Israel
        • Sheba MC, Tel-Hashomer
      • Rehovot, Israel
        • Kaplan MC
      • Tel Aviv, Israel
        • Assuta Ramat-HaHayal
      • Tel Aviv, Israel
        • Tel-Aviv Sourasky MC
      • Zrifin, Israel
        • Assaf-Harofeh MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects undergoing elective abdominal colon surgery involving resection and ileocolonic, ileorectal, colocolonic or colorectal anastomosis or with a stoma, who are preoperative stable hemodynamically. In a laparoscopic surgery, an abdominal wall incision ≥ 5 cm should be involved.
  2. Male or non-pregnant female.
  3. Females of childbearing potential should have a negative serum pregnancy test prior to index procedure. All females of childbearing potential must agree to use a highly effective method of contraception (e.g., double barrier, oral or parenteral hormonal, intrauterine device, or spermicide) consistently and correctly for the duration of the study.
  4. Age ≥ 18 years old at screening.
  5. Subjects who signed a written informed consent.
  6. Willing and able to participate and meet all study requirements.
  7. Survival expectancy of at least 60 days post randomization.

Exclusion Criteria:

  1. Subjects scheduled for abdominal surgery which is classified as emergency.
  2. Subjects with any preoperative active infection that is currently being treated with antibiotics.
  3. Subjects receiving any antibiotic therapy in the past 4 weeks prior to enrollment other than prophylaxis or antibiotic for the treatment of the disease for which the surgery is indicated.

  4. Subjects undergoing concomitant additional procedures other than colon resection surgery (e.g., hyper-thermic intraperitoneal chemotherapy, liver resection, etc.).

    Female sterilization surgery (e.g., salpingo-oophorectomy, hysterectomy, etc.), involvement of a small bowel procedure, or cholecystectomy may be allowed, pending an advanced consultation and approval from the sponsor.

  5. Subject received chemotherapy within the past 4 weeks of surgery, or radiation for colorectal cancer to the abdominal area, prior to the planned abdominal surgery (neo-adjuvant treatment).
  6. Subjects that received oral or IV doxycycline during the past 4 weeks prior to screening.
  7. Subjects with known hypersensitivity to doxycycline and/or to the tetracycline family of drugs or to the D-PLEX excipients.
  8. Subjects with known allergies to more than 3 substances (as determined from allergy questionnaire at screening).
  9. Subjects with history of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with intravenous steroids/intramuscular epinephrine or in the opinion of the investigator the subject is at high risk of developing severe allergic/hypersensitivity reactions.
  10. Subjects with uncontrolled asthma (GINA III-IV).
  11. Subjects with End Stage Renal Disease (ESRD/CKD stage 5).
  12. Subjects with chronic urticaria.
  13. Subjects diagnosed with TIA/CVA/ACS within the past 1 year prior to randomization.
  14. Subjects that have undergone any prior abdominal surgery and current planned surgery involves re-opening the scar of the prior abdominal surgery.

  15. Any subject with an active malignancy or malignancy that has not been in complete remission for at least 5 years. Excluding:

    • Subjects with potentially resectable non-metastatic colorectal cancer for which the surgery is indicated.
    • Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma of the skin, and basal cell carcinoma of the skin.
    • Subjects with non-violent cancer that does not require treatment 4 weeks prior to, and throughout the entire study duration.
  16. Subjects with other concurrent severe and/or uncontrolled medical condition that could compromise participation in the study (e.g., non-GI active infection, uncontrolled diabetes, uncontrolled hypertension, congestive heart failure, unstable angina, ventricular arrhythmias, active ischemic heart disease, uncompensated cirrhosis, active upper GI tract ulceration).
  17. Psychiatric, addictive, or any other disorder that compromises ability to provide informed consent for participation in this study.
  18. Chronic alcohol or drug abuse.
  19. Pregnant or breast-feeding women or women of childbearing age who refuse or are prohibited from using an effective contraceptive method of birth control (e.g., double barrier, oral or parenteral hormonal, intrauterine device, or spermicide) throughout study participation including the safety follow-up period.
  20. Subjects that received any investigational drug within 30 days or 5½ half-lives of enrollment in the study (whichever is longer).
  21. Subjects participating in any other interventional studies.
  22. Any subject who, in the opinion of the investigator, is not eligible to participate in the study and/or comply with protocol requirements (e.g., due to a cognitive or medical condition).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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.
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
Experimental: D-PLEX + SoC
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
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

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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Combined Infection and Mortality Rate Within 30 Days Post Index Surgery
Time Frame: 30 days post surgery
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
30 days post surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 30 days post surgery

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.
30 days post surgery
Mortality Rate Within 30 Days Post Abdominal Surgery
Time Frame: 30 days post surgery
Death from any reason within 30 days post abdominal surgery
30 days post surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Infection Rate
Time Frame: 30 days post-surgery
The number and proportion of subjects who experienced Surgical site infection (SSI) within 30 days
30 days post-surgery
Incidence of Superficial Surgical Site Infection (SSSI) During 30 Days Post-surgery
Time Frame: 30 days post surgery
The number and proportion of subjects who experienced at least one SSSI within 30 days post abdominal surgery were presented by treatment.
30 days post surgery
Incidence of Deep Surgical Site Infection (DSSI) During 30 Days Post-surgery
Time Frame: 30 days post surgery
The number and proportion of subjects who experienced at least one DSSI within 30 days post abdominal surgery were presented by treatment.
30 days post surgery
Mortality Rate Within 60 Days Post Abdominal Surgery
Time Frame: During 60 days of study participation
Death from any reason within 60 days post abdominal surgery
During 60 days of study participation
Number of Overall Hospitalization Days Post Surgery
Time Frame: During 60 days of study participation
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
During 60 days of study participation
Subject Hospitalization Due to SSI
Time Frame: 30 days post-surgery
The number and proportion of subjects hospitalized due to SSI within 30 days post-surgery
30 days post-surgery
Susceptibility to Doxycycline
Time Frame: 30 days post surgery

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.
30 days post surgery
Number of Re-admissions Due to Surgical Site Infection
Time Frame: During 30 days of study participation
The number and proportion of subjects with hospital re-admission due to SSI.
During 30 days of study participation
Number of Antibiotic Treatment Days Post Surgery
Time Frame: 60 days post surgery
The number of antibiotic treatment days due to SSI.
60 days post surgery
Subjects Receiving Antibiotics Due to SSI
Time Frame: 60 days post-surgery
The number and proportion of subjects who received antibiotics due to SSI
60 days post-surgery
Time to Surgical Site Infection
Time Frame: 30 days post surgery
Number of days between surgery and a confirmed incisional surgery infection
30 days post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PolyPid Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Shmuel Sharoni, MD, Medical director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 4, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 6, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 6, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D-PLEX 310

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Abdominal Surgery

Clinical Trials on Standard of Care (SoC)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings