Back to resultsD-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
Primary Purpose
Surgical Site Infection, Colon Surgery, Abdominal Surgery
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
D-PLEX
Standard of Care (SoC)
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection focused on measuring Surgical site infection, Abdominal surgery, Colon and small bowl surgery
Eligibility Criteria
INCLUSION CRITERIA:
- 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).
- Subjects are preoperative hemodynamically stable
- Male or non-pregnant female.
- Female of child-bearing potential should have a negative pregnancy test prior to index procedure.
- Subjects' age 18 years old and above at screening.
- Subjects who sign the written Informed Consent Form.
- Subjects who are willing and able to participate and meet all study requirements.
- Survival expectancy of at least 60 days post randomization
EXCLUSION CRITERIA
- 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.)
- Subjects who underwent an intra-abdominal surgery within the last 6 months prior to randomization.
- 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.
- Subjects undergoing concomitant major procedures in addition to the abdominal surgery, including concomitant repair of ventral hernia. Salpingo-oophorectomy and cholecystectomy are allowed.
- Subjects who received any anti-cancer treatment within the last 4 weeks of surgery.
- Subjects who received radiation for colorectal cancer to the abdomen area, prior to the planned abdominal surgery.
- Subjects who received oral or IV Doxycycline or Tetracycline family antibiotics during the past 4 weeks prior to randomization.
- Subjects with known allergy to Doxycycline and/or to the tetracycline family of drugs or to the D-PLEX's excipients.
- Subjects with known allergies to more than 3 substances (an allergy questionnaire will be completed during the screening process).
- 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.
- Subjects with End Stage Renal Disease (ESRD/ CKD stage 5).
- Subjects with severe hepatic impairment.
- Subjects with chronic urticaria.
- Subjects diagnosed with CVA within the past 6 months prior to randomization.
- 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.
- 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.
- Subjects with other concurrent severe and/or uncontrolled medical conditions.
- Psychiatric or any other disorder that compromises ability to provide informed consent for participation in this study.
- Chronic alcoholic or drug abuse subjects.
- 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.
- 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.
- Subjects participating in any other interventional study.
- 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).
Sites / Locations
- Shoals Medical Trials
- Cedars-Sinai Medical Center
- Paradigm Clinical Research Center
- Tufts Medical Center
- Siteman Cancer Center - South County
- Summit Medical Group
- "Multiprofile Hospital for Active Treatment - Blagoevgrad" AD
- "Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski - 2003" OOD
- "Multiprofile Hospital for Active Treatment St. Ivan Rilski Gorna Oryahovitsa" EOOD
- "Multiprofile Hospital for Active Treatment - Haskovo" AD
- "Multiprofile Hospital for Active Treatment - Uni Hospital" OOD
- "MHAT "Rahila Angelova"" AD
- "MHAT Sveta Caridad" EAD
- "Multiprofile hospital for active treatment - Plovdiv" AD
- University First Multiprofile Hospital for Active Treatment - Sofia
- "IV Multiprofile Hospital for Active Treatment - Sofia" EAD
- "University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov" EAD
- "Multiprofile Regional Hospital for Active Treatment "Dr. St. Cherkezov"" AD
- Complex Oncology Center - Vratsa - EOOD
- Multiprofile Hospital for Active Treatment
- "Multiprofile Hospital for Active Treatment "Sveti Panteleymon"-Yambol AD
- KBC Rijeka
- General Hospital Zadar
- KBC Sestre milosrdnice
- University Hospital Centre Zagreb
- Fakultní Nemocnice Brno
- Krajská nemocnice Liberec
- Fakultní Nemocnice Královské Vinohrady
- Nemocnice Na Bulovce
- Ustredni Vojenska Nemocnice Praha
- Bajai Szent Rókus Kórház, Sebészeti Osztály
- Békés-Megyei Központi Kórház, I. Sebészeti Osztály
- Csongrád-Csanád Megyei Egészségügyi Ellátó Központ Hódmezővásárhely - Makó
- Somogy Megyei Kaposi Mór Oktató Kórház, Sebészeti Osztály
- Orosházi Kórház, Invazív Mátrix Sebészet
- Pécsi Tudományegyetem, Klinikai Központ, Sebészeti Klinika
- Fejér Megyei Szent György Egyetemi Oktató Kórház, Sebészeti Osztály
- Sheba Medical Center
- West Galilee medical Center
- Kaplan Medical Center
- Rabin Medical Center
- Assuta Medical center
- Sourasky Medical Center
- Shamir Medical Center
- IMSP Institut of Emmergency Medicine
- IMSP Clinical republican Hospital "Timofei Mosneaga"
- IMSP Intitute of Oncology
- IMSP Municipal Clinical Hospital "Sfanta Treime"
- "Sf. Constantin" Hospital
- Emergency University Hospital Elias, Clinical Department of General Surgery
- Coltea Clinical Hospital
- Clinical County Hospital Cluj Napoca
- "Prof. Dr. Octavian Fodor"
- Medical Center Dr.Ianosi, Department of Surgery
- County Emergency Clinical Hospital Craiova, Department of General Surgery II
- Spitalul Clinic Judetean de Urgentã Craiova
- Spitalul Clinic Judetean de Urgentã Targu-Mures
- Pelican Hospital Oradea
- County Emergency Clinical Hospital Timisoara "Pius Brînzeu"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
D-PLEX+SoC
Standard of care
Arm Description
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
The SoC for prophylactic antibiotic treatment is based on international guidelines
Outcomes
Primary Outcome Measures
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)].
Secondary Outcome Measures
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)].
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04233424
Brief Title
D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 24, 2020 (Actual)
Primary Completion Date
September 2, 2022 (Actual)
Study Completion Date
September 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PolyPid Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection, Colon Surgery, Abdominal Surgery, Post-Op Infection
Keywords
Surgical site infection, Abdominal surgery, Colon and small bowl surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
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.
Masking
ParticipantCare ProviderInvestigator
Masking Description
This is a double-blind clinical trial. The sponsor, the subjects, outcomes assessor and all staff involved in the collection and recording of the clinical and laboratory data, based on which the independent adjudication committee will perform their assessment, will be blind to treatment assignment. In addition, all aspects of data management and clean-up will be done in blinded datasets.
The study site personnel, who perform the index surgery (Operation room staff), will be trained not to disclose the treatment arm to the blinded Investigator, to the subject, his/her family, to other health care providers not present during the surgery or to the study Sponsor representatives. Wound assessment throughout the study follow-up visits will be done by a blinded Investigator, that will not be involved in the surgery. An emergency card containing the Study Name, NIH number, Center Name/number, PI's name and contact details will be provided to the subjects.
Allocation
Randomized
Enrollment
950 (Actual)
8. Arms, Groups, and Interventions
Arm Title
D-PLEX+SoC
Arm Type
Experimental
Arm Description
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
Arm Title
Standard of care
Arm Type
Other
Arm Description
The SoC for prophylactic antibiotic treatment is based on international guidelines
Intervention Type
Drug
Intervention Name(s)
D-PLEX
Intervention Description
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 β Tri-Calcium polymer and a lipid matrix. All formulation components are biodegradable.
Intervention Type
Other
Intervention Name(s)
Standard of Care (SoC)
Intervention Description
prophylactic, pre-operation per institution guidelines
Primary Outcome Measure Information:
Title
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.
Description
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)].
Time Frame
By day 30 post surgery
Secondary Outcome Measure Information:
Title
Assessment of Infection rate in patient undergoing abdominal colon surgery
Description
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)].
Time Frame
At study visits: day 1, day 5, day 14 and day 30 post surgery
Other Pre-specified Outcome Measures:
Title
Assess Safety of D-PLEX in Prevention of Post Abdominal Surgery Incisional
Description
Safety parameters will be evaluated by adverse events
Time Frame
By day 60 post surgery
Title
All-cause mortality and re-interventions in the target incision due to SSI
Description
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.
Time Frame
By day 30 post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA:
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).
Subjects are preoperative hemodynamically stable
Male or non-pregnant female.
Female of child-bearing potential should have a negative pregnancy test prior to index procedure.
Subjects' age 18 years old and above at screening.
Subjects who sign the written Informed Consent Form.
Subjects who are willing and able to participate and meet all study requirements.
Survival expectancy of at least 60 days post randomization
EXCLUSION CRITERIA
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.)
Subjects who underwent an intra-abdominal surgery within the last 6 months prior to randomization.
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.
Subjects undergoing concomitant major procedures in addition to the abdominal surgery, including concomitant repair of ventral hernia. Salpingo-oophorectomy and cholecystectomy are allowed.
Subjects who received any anti-cancer treatment within the last 4 weeks of surgery.
Subjects who received radiation for colorectal cancer to the abdomen area, prior to the planned abdominal surgery.
Subjects who received oral or IV Doxycycline or Tetracycline family antibiotics during the past 4 weeks prior to randomization.
Subjects with known allergy to Doxycycline and/or to the tetracycline family of drugs or to the D-PLEX's excipients.
Subjects with known allergies to more than 3 substances (an allergy questionnaire will be completed during the screening process).
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.
Subjects with End Stage Renal Disease (ESRD/ CKD stage 5).
Subjects with severe hepatic impairment.
Subjects with chronic urticaria.
Subjects diagnosed with CVA within the past 6 months prior to randomization.
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.
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.
Subjects with other concurrent severe and/or uncontrolled medical conditions.
Psychiatric or any other disorder that compromises ability to provide informed consent for participation in this study.
Chronic alcoholic or drug abuse subjects.
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.
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.
Subjects participating in any other interventional study.
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).
Facility Information:
Facility Name
Shoals Medical Trials
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Paradigm Clinical Research Center
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Siteman Cancer Center - South County
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Summit Medical Group
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
"Multiprofile Hospital for Active Treatment - Blagoevgrad" AD
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
"Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski - 2003" OOD
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Facility Name
"Multiprofile Hospital for Active Treatment St. Ivan Rilski Gorna Oryahovitsa" EOOD
City
Gorna Oryahovitsa
ZIP/Postal Code
5100
Country
Bulgaria
Facility Name
"Multiprofile Hospital for Active Treatment - Haskovo" AD
City
Haskovo
ZIP/Postal Code
6304
Country
Bulgaria
Facility Name
"Multiprofile Hospital for Active Treatment - Uni Hospital" OOD
City
Panagyurishte
ZIP/Postal Code
4500
Country
Bulgaria
Facility Name
"MHAT "Rahila Angelova"" AD
City
Pernik
ZIP/Postal Code
2300
Country
Bulgaria
Facility Name
"MHAT Sveta Caridad" EAD
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
"Multiprofile hospital for active treatment - Plovdiv" AD
City
Plovdiv
ZIP/Postal Code
4027
Country
Bulgaria
Facility Name
University First Multiprofile Hospital for Active Treatment - Sofia
City
Sofia
ZIP/Postal Code
1154
Country
Bulgaria
Facility Name
"IV Multiprofile Hospital for Active Treatment - Sofia" EAD
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
"University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov" EAD
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
"Multiprofile Regional Hospital for Active Treatment "Dr. St. Cherkezov"" AD
City
Veliko Tarnovo
ZIP/Postal Code
5002
Country
Bulgaria
Facility Name
Complex Oncology Center - Vratsa - EOOD
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment
City
Vratsa
ZIP/Postal Code
3001
Country
Bulgaria
Facility Name
"Multiprofile Hospital for Active Treatment "Sveti Panteleymon"-Yambol AD
City
Yambol
ZIP/Postal Code
8600
Country
Bulgaria
Facility Name
KBC Rijeka
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
General Hospital Zadar
City
Zadar
ZIP/Postal Code
23000
Country
Croatia
Facility Name
KBC Sestre milosrdnice
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Fakultní Nemocnice Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Krajská nemocnice Liberec
City
Liberec
ZIP/Postal Code
46001
Country
Czechia
Facility Name
Fakultní Nemocnice Královské Vinohrady
City
Prague
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Nemocnice Na Bulovce
City
Prague
ZIP/Postal Code
18081
Country
Czechia
Facility Name
Ustredni Vojenska Nemocnice Praha
City
Praha
ZIP/Postal Code
169 02
Country
Czechia
Facility Name
Bajai Szent Rókus Kórház, Sebészeti Osztály
City
Baja
State/Province
Bács-Kiskun Megye
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Békés-Megyei Központi Kórház, I. Sebészeti Osztály
City
Gyula
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Csongrád-Csanád Megyei Egészségügyi Ellátó Központ Hódmezővásárhely - Makó
City
Hódmezővásárhely
ZIP/Postal Code
6800
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház, Sebészeti Osztály
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Orosházi Kórház, Invazív Mátrix Sebészet
City
Orosháza
ZIP/Postal Code
5900
Country
Hungary
Facility Name
Pécsi Tudományegyetem, Klinikai Központ, Sebészeti Klinika
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Fejér Megyei Szent György Egyetemi Oktató Kórház, Sebészeti Osztály
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Sheba Medical Center
City
Ramat Gan
State/Province
Derech Sheba 2
Country
Israel
Facility Name
West Galilee medical Center
City
Nahariya
State/Province
Nahariya-Cabri
ZIP/Postal Code
22100
Country
Israel
Facility Name
Kaplan Medical Center
City
Reẖovot
State/Province
Pasternak Saint
ZIP/Postal Code
76100
Country
Israel
Facility Name
Rabin Medical Center
City
Pethah Tiqvā
Country
Israel
Facility Name
Assuta Medical center
City
Tel Aviv
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Shamir Medical Center
City
Zrifin
Country
Israel
Facility Name
IMSP Institut of Emmergency Medicine
City
Chisinau
ZIP/Postal Code
2004
Country
Moldova, Republic of
Facility Name
IMSP Clinical republican Hospital "Timofei Mosneaga"
City
Chisinau
ZIP/Postal Code
2025
Country
Moldova, Republic of
Facility Name
IMSP Intitute of Oncology
City
Chisinau
ZIP/Postal Code
2025
Country
Moldova, Republic of
Facility Name
IMSP Municipal Clinical Hospital "Sfanta Treime"
City
Chisinau
ZIP/Postal Code
2068
Country
Moldova, Republic of
Facility Name
"Sf. Constantin" Hospital
City
Brasov
ZIP/Postal Code
500388
Country
Romania
Facility Name
Emergency University Hospital Elias, Clinical Department of General Surgery
City
Bucharest
ZIP/Postal Code
11461
Country
Romania
Facility Name
Coltea Clinical Hospital
City
Bucharest
ZIP/Postal Code
30171
Country
Romania
Facility Name
Clinical County Hospital Cluj Napoca
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
"Prof. Dr. Octavian Fodor"
City
Cluj-Napoca
ZIP/Postal Code
400162
Country
Romania
Facility Name
Medical Center Dr.Ianosi, Department of Surgery
City
Craiova
ZIP/Postal Code
200061
Country
Romania
Facility Name
County Emergency Clinical Hospital Craiova, Department of General Surgery II
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgentã Craiova
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgentã Targu-Mures
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Pelican Hospital Oradea
City
Oradea
ZIP/Postal Code
410469
Country
Romania
Facility Name
County Emergency Clinical Hospital Timisoara "Pius Brînzeu"
City
Timisoara
ZIP/Postal Code
300723
Country
Romania
12. IPD Sharing Statement
Learn more about this trial
D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
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