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

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: Completed
• Conditions: Abdominal Surgery; Colon Surgery; Post-Op Infection
• Intervention / Treatment: Other: Standard of Care (SoC); Drug: D-PLEX

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: Interventional
• Enrollment (Actual): 202
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
The Combined Infection and Mortality Rate Within 30 Days Post Index 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

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.	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	Death from any reason within 30 days post abdominal surgery	30 days post surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection Rate	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	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	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	Death from any reason within 60 days post abdominal surgery	During 60 days of study participation
Number of Overall Hospitalization Days Post Surgery	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	The number and proportion of subjects hospitalized due to SSI within 30 days post-surgery	30 days post-surgery
Susceptibility to Doxycycline	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	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	The number of antibiotic treatment days due to SSI.	60 days post surgery
Subjects Receiving Antibiotics Due to SSI	The number and proportion of subjects who received antibiotics due to SSI	60 days post-surgery
Time to Surgical Site Infection	Number of days between surgery and a confirmed incisional surgery infection	30 days post surgery

Collaborators and Investigators

• Sponsor: PolyPid Ltd.
• Investigators: Study Chair: Shmuel Sharoni, MD, Medical director

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2018
• Primary Completion (Actual): September 6, 2019
• Study Completion (Actual): October 6, 2019

Study Registration Dates

• First Submitted: June 21, 2018
• First Submitted That Met QC Criteria: August 12, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Surgical site infection; Abdominal surgery; Colon and small bowl surgery
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Infections; Wound Infection; Pathological Conditions, Signs and Symptoms; Surgical Wound Infection; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID 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