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

NCT03633123 | Completed Phase 2 Results DMC

• 1 other identifier: D-PLEX 310
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Abdominal Surgery; Colon Surgery; Post-Op Infection

Keywords

Surgical site infection; Abdominal surgery; Colon and small bowl surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

  30 days post surgery

• Mortality Rate Within 30 Days Post Abdominal Surgery

  30 days post surgery

Other Outcomes (11)

• Infection Rate

  30 days post-surgery

• Incidence of Superficial Surgical Site Infection (SSSI) During 30 Days Post-surgery

  30 days post surgery

• Incidence of Deep Surgical Site Infection (DSSI) During 30 Days Post-surgery

  30 days post surgery

Study Arms (2)

Standard of Care (SoC)

OTHER

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)

D-PLEX + SoC

EXPERIMENTAL

D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment

Drug: D-PLEX; Other: Standard of Care (SoC)

Interventions

D-PLEX DRUG

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).

D-PLEX + SoC

Standard of Care (SoC) OTHER

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

D-PLEX + SoC; Standard of Care (SoC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Male or non-pregnant female.
• 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.
• Age ≥ 18 years old at screening.
• Subjects who signed a written informed consent.
• Willing and able to participate and meet all study requirements.
• Survival expectancy of at least 60 days post randomization.

You may not qualify if:

• Subjects scheduled for abdominal surgery which is classified as emergency.
• Subjects with any preoperative active infection that is currently being treated with antibiotics.
• 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.
• 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.
• 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).
• Subjects that received oral or IV doxycycline during the past 4 weeks prior to screening.
• Subjects with known hypersensitivity to doxycycline and/or to the tetracycline family of drugs or to the D-PLEX excipients.
• Subjects with known allergies to more than 3 substances (as determined from allergy questionnaire at screening).
• 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.
• Subjects with uncontrolled asthma (GINA III-IV).
• Subjects with End Stage Renal Disease (ESRD/CKD stage 5).
• Subjects with chronic urticaria.
• Subjects diagnosed with TIA/CVA/ACS within the past 1 year prior to randomization.
• Subjects that have undergone any prior abdominal surgery and current planned surgery involves re-opening the scar of the prior abdominal surgery.

Sponsors & Collaborators

• PolyPid Ltd.: lead

Study Sites (8)

Wolfson MC

Holon, Israel

Location

Meir MC

Kfar Saba, Israel

Location

Rabin MC, Campus Beilinson

Petah Tikva, Israel

Location

Sheba MC, Tel-Hashomer

Ramat Gan, Israel

Location

Kaplan MC

Rehovot, Israel

Location

Assuta Ramat-HaHayal

Tel Aviv, Israel

Location

Tel-Aviv Sourasky MC

Tel Aviv, Israel

Location

Assaf-Harofeh MC

Zrifin, Israel

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Eyal Shoshani, VP Clinical Affaies
• Organization: PolyPid

eyal.s@polypid.com

+972-74-719-5700

Study Officials

• Shmuel Sharoni, MD

  Medical Director

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Subject will be blinded to the treatment arm assignment. Physicians which were not part of the team in the surgery room, or from the hospital's infectious diseases dept. will remain blinded to the study arm, and will be those assessing the incisional wound for the study primary endpoint at each follow-up visit post the index surgery. On top, for each suspicion of infection, an external, independent and blinded adjudication committee will be the one making the final decision whether an infection occured or not.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Males and females, \>18 years old, undergoing scheduled abdominal colon surgery involving resection and anastomosis or a stoma, who meet the inclusion criteria and none of the exclusion criteria and provide signed informed consent will be enrolled in the study. Subjects will be randomized to either the investigational arm (SOC + D-PLEX) or to the control arm (SOC only) in a 1:1 ratio. Subjects will be blinded to the study arm.

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: August 16, 2018
• Study Start: October 4, 2018
• Primary Completion: September 6, 2019
• Study Completion: October 6, 2019
• Last Updated: March 24, 2026
• Results First Posted: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (8)