Surgical Site Infection Clinical Trial
Official title:
D-PLEX 311- Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX In Prevention of Post Abdominal Surgery Incisional Infection(SHIELD I)
Verified date | May 2022 |
Source | PolyPid Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
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 |
Lead Sponsor | Collaborator |
---|---|
PolyPid Ltd. |
United States, Bulgaria, Croatia, Czechia, Hungary, Israel, Moldova, Republic of, Romania,
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 |
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