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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-04

Study Completion Date

2019-10-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection

NCT04233424

Surgical Site Infection Colon Surgery Abdominal Surgery +1 more

COMPLETED PHASE3

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

NCT04411199

Surgical Site Infection Colon Surgery Abdominal Surgery +1 more

COMPLETED PHASE3

Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery

NCT04580472

Surgical Site Infection

RECRUITING PHASE4

The Effect of Prophylactic Antibiotics on Surgical Site Infection Lower Limb Skin Excisions

NCT03357419

Skin Lesion

WITHDRAWN NA

Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery

NCT01888367

Surgical Site Infections

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 manor 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 PK (for some only) as well as physicians assessment of the incisional wound.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Abdominal Surgery Colon Surgery Post-Op Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Standard of Care (SoC)

Intervention Type 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

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

Group Type EXPERIMENTAL

D_PLEX

Intervention Type 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).

Standard of Care (SoC)

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DRUG

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subjects undergoing elective abdominal colon surgery involving resection and anastomosis or a stoma.
2. Male or non-pregnant female Female of childbearing potential should have a negative serum pregnancy test prior to index procedure and agree to use a highly effective method of contraception consistently and correctly for the duration of the study.
3. Subjects who sign a written informed consent
4. Subjects who are willing and able to participate and meet all study requirements.
5. 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 enrolment besides prophylaxis or antibiotic for the treatment of the disease that consists the indication for surgery.
4. Patients undergoing concomitant additional procedures besides colon resection surgery, e.g. Hyper-thermic Intraperitoneal Chemotherapy, liver resection etc. Female sterilization surgery (i.e. salpingo-oophorectomy, hysterectomy etc.), or 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 last 4 weeks of surgery, or radiation for colorectal cancer to the abdomen 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 sensitivity to doxycycline and/or to the tetracycline family of drugs or to the D-PLEX's excipients.
8. Subjects with known allergies to more than 3 substances (an allergy questionnaire will be filled in during the screening process).
9. Subjects with a 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 patient 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 \[Chronic Kidney Disease (CKD) stage 5\].
12. Subjects with chronic urticaria.
13. Subjects diagnosed with severe neurological/cardiac events within the past 1 year prior to randomization.
14. Subjects that undergone any abdominal surgery and current planned surgery involves re-opening the scar of prior abdominal surgery.
15. Any subject with active malignancy or with malignancy that has not been in complete remission for at least 5 years.

Excluding:
* subjects with potentially resectable non-metastatic colorectal cancer which consists the indication for surgery. In addition,
* patients Patients who have had carcinoma in situ of the cervix, squamous cell carcinoma of the skin and basal cell carcinoma of the skin
* Non-violent cancer that does not require treatment 4 weeks prior to, and throughout the entire study duration will be eligible.
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 gastrointestinal (GI) tract ulceration).
17. Psychiatric, addictive, or any other disorder that compromises ability to provide informed consent for participation in this study.
18. Chronic alcoholic or drug abuse subjects.
19. Pregnant or breast-feeding women or women of childbearing age who refuse or prohibited of using an effective contraceptive method of birth control (such as double barrier, oral or parenteral hormonal, intrauterine device and spermicide) throughout study participation including safety follow-up period.
20. Subjects that received any investigational drug within 30 days or 5½ half-lives of enrollment to the study (whichever is longer).
21. Subjects participating in any other interventional studies.
22. In the opinion of investigator, subject is not eligible to participate in the study and/or to comply with protocol requirements (e.g. due to a cognitive or medical condition).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No