Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04233424
Other study ID # D-PLEX 311
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 24, 2020
Est. completion date September 2, 2022

Study information

Verified date May 2022
Source PolyPid Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), compared to a SoC treated control arm, in prevention of post abdominal surgery incisional infection.


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. The study population includes male and female, 18 years old and above at screening, undergoing an elective colorectal surgery involving resection, with or without a stoma, that includes at least 1 incision that is > 10 cm (target incision). Eligible and willing subjects will be randomly allocated into 2 blinded 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 and chemistry well as physicians assessment of the incisional wound. The final number of subjects will be determined following a comparative interim analysis for an early efficacy or futility stop or unblinded sample size re-estimation: when about 750 subjects will complete their 30 days (1 month) follow-up and evaluated for primary endpoint


Recruitment information / eligibility

Status Completed
Enrollment 950
Est. completion date September 2, 2022
Est. primary completion date September 2, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility INCLUSION CRITERIA: 1. Subjects undergoing an elective colorectal surgery involving resection, with or without a stoma formation, that includes at least 1 abdominal incision that is > 10cm (target incision). 2. Subjects are preoperative hemodynamically stable 3. Male or non-pregnant female. 4. Female of child-bearing potential should have a negative pregnancy test prior to index procedure. 5. Subjects' age 18 years old and above at screening. 6. Subjects who sign the written Informed Consent Form. 7. Subjects who are willing and able to participate and meet all study requirements. 8. Survival expectancy of at least 60 days post randomization EXCLUSION CRITERIA 1. Subjects with suspected/diagnosed intestinal perforation, intra-abdominal abscess, or any emergency/urgent colorectal surgery with acute intestinal obstruction (ex. toxic colitis, ileus/sub-ileus, megacolon, diverticulitis, volvulus, ect.) 2. Subjects who underwent an intra-abdominal surgery within the last 6 months prior to randomization. 3. Subjects with any preoperative active infection or who are receiving any antibiotic therapy in the past 1 week prior to randomization, excluding pre-operative prophylaxis. 4. Subjects undergoing concomitant major procedures in addition to the abdominal surgery, including concomitant repair of ventral hernia. Salpingo-oophorectomy and cholecystectomy are allowed. 5. Subjects who received any anti-cancer treatment within the last 4 weeks of surgery. 6. Subjects who received radiation for colorectal cancer to the abdomen area, prior to the planned abdominal surgery. 7. Subjects who received oral or IV Doxycycline or Tetracycline family antibiotics during the past 4 weeks prior to randomization. 8. Subjects with known allergy to Doxycycline and/or to the tetracycline family of drugs or to the D-PLEX's excipients. 9. Subjects with known allergies to more than 3 substances (an allergy questionnaire will be completed during the screening process). 10. Subjects with history of severe allergic reaction to any substance, having required treatment with intravenous steroids/intramuscular epinephrine, or who in the opinion of the PI is at high risk of developing severe allergic reactions. 11. Subjects with End Stage Renal Disease (ESRD/ CKD stage 5). 12. Subjects with severe hepatic impairment. 13. Subjects with chronic urticaria. 14. Subjects diagnosed with CVA within the past 6 months prior to randomization. 15. Subjects who underwent any abdominal surgery and current planned index surgery involves re-opening the scar of a prior abdominal surgery performed within the last 3 years. 16. Any subject with an active malignancy, other than resectable non-metastatic colorectal cancer, that is the reason for the index surgery, or carcinoma in situ (or other cancer "in situ = Stage 0"), or squamous cell carcinoma of the skin, or basal cell carcinoma of the skin, or a malignancy that has not been in complete clinical remission and without maintenance chemo or immunotherapy for at least 3 years. 17. Subjects with other concurrent severe and/or uncontrolled medical conditions. 18. Psychiatric or any other disorder that compromises ability to provide informed consent for participation in this study. 19. Chronic alcoholic or drug abuse subjects. 20. Pregnant or breast-feeding women or women of child-bearing age who refuse or are prohibited of using an effective contraceptive method of birth control throughout study participation, including the safety follow-up period. 21. Subjects who received any investigational drug within 30 days or 5 half-lives prior to randomization to the study (whichever is longer) and through the study. 22. Subjects participating in any other interventional study. 23. Subjects, who in the opinion of Investigator, are not eligible to participate in the study and/or to comply with the protocol requirements (e.g. due to a cognitive or medical condition).

Study Design


Intervention

Drug:
D-PLEX
D-PLEX is a new formulation of extended release of Doxycycline. Each 5g D-PLEX vial contains 54.6mg Doxycycline free base (1.09%), which is equivalent to 63mg Doxycycline hyclate (1.26%). D-PLEX is supplied as a sterile powder to be reconstituted to paste in the operating room, using standard aseptic techniques and is intended for single administration. The non-active components of the extended release antibiotic formulation are ß Tri-Calcium polymer and a lipid matrix. All formulation components are biodegradable.
Other:
Standard of Care (SoC)
prophylactic, pre-operation per institution guidelines

Locations

Country Name City State
Bulgaria "Multiprofile Hospital for Active Treatment - Blagoevgrad" AD Blagoevgrad
Bulgaria "Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski - 2003" OOD Dupnitsa
Bulgaria "Multiprofile Hospital for Active Treatment St. Ivan Rilski Gorna Oryahovitsa" EOOD Gorna Oryahovitsa
Bulgaria "Multiprofile Hospital for Active Treatment - Haskovo" AD Haskovo
Bulgaria "Multiprofile Hospital for Active Treatment - Uni Hospital" OOD Panagyurishte
Bulgaria "MHAT "Rahila Angelova"" AD Pernik
Bulgaria "MHAT Sveta Caridad" EAD Plovdiv
Bulgaria "Multiprofile hospital for active treatment - Plovdiv" AD Plovdiv
Bulgaria "IV Multiprofile Hospital for Active Treatment - Sofia" EAD Sofia
Bulgaria "University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov" EAD Sofia
Bulgaria University First Multiprofile Hospital for Active Treatment - Sofia Sofia
Bulgaria "Multiprofile Regional Hospital for Active Treatment "Dr. St. Cherkezov"" AD Veliko Tarnovo
Bulgaria Complex Oncology Center - Vratsa - EOOD Vratsa
Bulgaria Multiprofile Hospital for Active Treatment Vratsa
Bulgaria "Multiprofile Hospital for Active Treatment "Sveti Panteleymon"-Yambol AD Yambol
Croatia KBC Rijeka Rijeka
Croatia General Hospital Zadar Zadar
Croatia KBC Sestre milosrdnice Zagreb
Croatia University Hospital Centre Zagreb Zagreb
Czechia Fakultní Nemocnice Brno Brno
Czechia Krajská nemocnice Liberec Liberec
Czechia Fakultní Nemocnice Královské Vinohrady Prague
Czechia Nemocnice Na Bulovce Prague
Czechia Ustredni Vojenska Nemocnice Praha Praha
Hungary Bajai Szent Rókus Kórház, Sebészeti Osztály Baja Bács-Kiskun Megye
Hungary Békés-Megyei Központi Kórház, I. Sebészeti Osztály Gyula
Hungary Csongrád-Csanád Megyei Egészségügyi Ellátó Központ Hódmezovásárhely - Makó Hódmezovásárhely
Hungary Somogy Megyei Kaposi Mór Oktató Kórház, Sebészeti Osztály Kaposvár
Hungary Orosházi Kórház, Invazív Mátrix Sebészet Orosháza
Hungary Pécsi Tudományegyetem, Klinikai Központ, Sebészeti Klinika Pécs
Hungary Fejér Megyei Szent György Egyetemi Oktató Kórház, Sebészeti Osztály Székesfehérvár
Israel West Galilee medical Center Nahariya Nahariya-Cabri
Israel Rabin Medical Center Pethah Tiqva
Israel Sheba Medical Center Ramat Gan Derech Sheba 2
Israel Kaplan Medical Center Re?ovot Pasternak Saint
Israel Assuta Medical center Tel Aviv
Israel Sourasky Medical Center Tel Aviv
Israel Shamir Medical Center Zrifin
Moldova, Republic of IMSP Clinical republican Hospital "Timofei Mosneaga" Chisinau
Moldova, Republic of IMSP Institut of Emmergency Medicine Chisinau
Moldova, Republic of IMSP Intitute of Oncology Chisinau
Moldova, Republic of IMSP Municipal Clinical Hospital "Sfanta Treime" Chisinau
Romania "Sf. Constantin" Hospital Brasov
Romania Coltea Clinical Hospital Bucharest
Romania Emergency University Hospital Elias, Clinical Department of General Surgery Bucharest
Romania "Prof. Dr. Octavian Fodor" Cluj-Napoca
Romania Clinical County Hospital Cluj Napoca Cluj-Napoca
Romania County Emergency Clinical Hospital Craiova, Department of General Surgery II Craiova
Romania Medical Center Dr.Ianosi, Department of Surgery Craiova
Romania Spitalul Clinic Judetean de Urgentã Craiova Craiova
Romania Spitalul Clinic Judetean de Urgentã Targu-Mures Craiova
Romania Pelican Hospital Oradea Oradea
Romania County Emergency Clinical Hospital Timisoara "Pius Brînzeu" Timisoara
United States Summit Medical Group Bend Oregon
United States Tufts Medical Center Boston Massachusetts
United States Cedars-Sinai Medical Center Los Angeles California
United States Paradigm Clinical Research Center Redding California
United States Siteman Cancer Center - South County Saint Louis Missouri
United States Shoals Medical Trials Sheffield Alabama

Sponsors (1)

Lead Sponsor Collaborator
PolyPid Ltd.

Countries where clinical trial is conducted

United States,  Bulgaria,  Croatia,  Czechia,  Hungary,  Israel,  Moldova, Republic of,  Romania, 

Outcome

Type Measure Description Time frame Safety issue
Other Assess Safety of D-PLEX in Prevention of Post Abdominal Surgery Incisional Safety parameters will be evaluated by adverse events By day 60 post surgery
Other All-cause mortality and re-interventions in the target incision due to SSI All-cause mortality and re-intervention at the primary incision site (target) due to suspected SSI or due to poor wound healing, including wound dehiscence (as verified by the blinded adjudication committee), within 30 days post index surgery will be analysed as treatment failure. By day 30 post surgery
Primary To assess the anti-infective efficacy of D-PLEX over a period of 30 days post operation, by preventing surgical site infection (SSI), defined as superficial and deep infection, in the target incision(s), compared to the SoC treated control. Infection rate as measured by the proportion of subjects with at least one abdominal incisional infection event, as determined by a blinded and independent adjudication committee, within 30 days post abdominal surgery. [abdominal incisional infection is composed of Deep Incisional Surgical Site Infection (DSSI) and Superficial Incisional Surgical Site Infection (SSSI)]. By day 30 post surgery
Secondary Assessment of Infection rate in patient undergoing abdominal colon surgery infection rate as measured by the proportion of subjects with at least one abdominal incisional infection event, as determined by a blinded and independent adjudication committee, within 30 days post abdominal surgery.
[abdominal incisional infection is composed of Deep Incisional Surgical Site Infection (DSSI) and Superficial Incisional Surgical Site Infection (SSSI)].
At study visits: day 1, day 5, day 14 and day 30 post surgery
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04096885 - The Inselspital Surgical Cohort Study
Terminated NCT03820648 - Wound Protector Dual-ring Alexis® in Pancreaticoduodenectomy N/A
Completed NCT04067843 - Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study N/A
Terminated NCT04042077 - Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections Phase 3
Completed NCT05841576 - Anaesthetic Management Guided by COMET Measurements N/A
Withdrawn NCT05338281 - NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT N/A
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Completed NCT01697748 - Prospective Study on Cesarean Wound Outcomes N/A
Terminated NCT01789697 - Text Message Study N/A
Recruiting NCT05966961 - Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Recruiting NCT05077592 - Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections Phase 4
Recruiting NCT05502380 - Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery Phase 3
Recruiting NCT05763602 - PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study) Phase 4
Recruiting NCT03221023 - Intrawound Vancomycin Prophylaxis for Neural Stimulator Phase 2/Phase 3
Completed NCT03257202 - Topical Treatment and Prevalence of P. Acnes Phase 2
Completed NCT06154720 - Surgical Site Infection After Episiotomy Repair Related to Routine Use of Antibiotic Prophylaxis in Low-Risk Population
Not yet recruiting NCT06465901 - A Stratified, Multi-ARm, muLti-site Randomised Platform Trial Aiming to Reduce the INcidence of Post-operative SSI N/A
Not yet recruiting NCT04820075 - Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery N/A
Recruiting NCT03561376 - Zinc Oxide Versus Petrolatum Following Skin Surgery Early Phase 1
Not yet recruiting NCT04496180 - Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy N/A