A-Part® Gel as Adhesion Prophylaxis After Major Abdominal Surgery Versus a Non-treated Group
NCT ID: NCT00646412
Last Updated: 2015-09-09
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
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1/PHASE2
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2008-07-31
Study Completion Date
2010-08-31
Brief Summary
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The safety of applying A-Part® Gel intra-peritoneally under the incision in order to prevent post-surgical adhesions after median laparotomy.
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Detailed Description
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Primary Objective:
• first assessment of the safety of applying A-Part® Gel as adhesion prophylaxis after major abdominal surgery by specific observation of two major complications of abdominal surgery (wound healing impairment, and/or postoperative peritonitis) in comparison to a control group.
Secondary Objectives:
* To further evaluate the safety of A-Part® Gel by comparing the incidences of adverse events between the treatment groups (with special attention to anastomosis leakage)
* To explore the efficacy of A-Part® Gel in reducing post-surgical adhesions after median laparotomy
• first assessment of the safety of applying A-Part® Gel as adhesion prophylaxis after major abdominal surgery by specific observation of two major complications of abdominal surgery (wound healing impairment, and/or postoperative peritonitis) in comparison to a control group.
Secondary Objectives:
* To further evaluate the safety of A-Part® Gel by comparing the incidences of adverse events between the treatment groups (with special attention to anastomosis leakage)
* To explore the efficacy of A-Part® Gel in reducing post-surgical adhesions after median laparotomy
Conditions
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Adhesions
Abdominal Cavity
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Participants
Study Groups
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A
A-Part® Gel
Group Type
EXPERIMENTAL
A-Part® Gel
Intervention Type
DEVICE
10 - 20 ml of A-Part® Gel will be administered before abdominal wall closure in a standardised fashion
B
untreated control group
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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A-Part® Gel
10 - 20 ml of A-Part® Gel will be administered before abdominal wall closure in a standardised fashion
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Patients of both sexes, who are candidates for a primary and elective median abdominal incision with a length of ≥ 15 cm 2.
* Age ≥ 18 years
* Patients who are legally capable and able to understand the nature, significance and consequences of the study and are willing and able to comply with the study protocol and the follow up
* Written informed consent obtained according to international guidelines and local law. Informed consent will be documented by the volunteer's dated signature, which will be also signed and dated by the investigator
* Patients with an expected survival time \>12 months
* For female adults of reproductive potential: Negative pregnancy test at visit 1 and sufficient contraception from time of written consent up to at least 4 months
* Age ≥ 18 years
* Patients who are legally capable and able to understand the nature, significance and consequences of the study and are willing and able to comply with the study protocol and the follow up
* Written informed consent obtained according to international guidelines and local law. Informed consent will be documented by the volunteer's dated signature, which will be also signed and dated by the investigator
* Patients with an expected survival time \>12 months
* For female adults of reproductive potential: Negative pregnancy test at visit 1 and sufficient contraception from time of written consent up to at least 4 months
Exclusion Criteria
* Patients with a previous median laparotomy and any other abdominal surgery (exceptions: previous laparoscopic appendectomy, cholecystectomy, inguinal hernia repair, gynecological tube sterilisation)
* Patients with a known history of adhesions or a known history of peritonitis
* Patients with a known sensitivity to polyvinylalcohol and/or carboxymethylcellulose
* Simultaneous participation of the patient in another clinical trial or participation in a clinical trial within the last 30 days prior to signing the Informed consent form
* Patients with ASA \> 3 or emergency patients (including severe psychic diesease)
* Patients with ascites \> 200 ml
* Patients with peritoneal carcinosis or peritoneal dialysis
* Patients with a diagnosed peritonitis, intra-abdominal abscess or other intra-abdominal infection
* Patient with renal impairment (Creatinine \> 1.3 mg/dl)
* Patients with systemic immunosuppression (e.g. hydrocortisone \> 50mg daily \[oral/i.v.\] at any day or any equivalent dosage; other immunosuppressants like Azathioprin, Mycophenolatmofetil, Ciclosporin, Everolimus, Methotrexat, ect.), chemotherapy or radiotherapy within the last 2 weeks prior to surgery
* Surgical procedures or patient characteristics which require insertion of more than 2 intra-abdominal drainages
* Women within a pregnancy or breast-feeding mothers or women who wish to get pregnant within the next 4 months after surgery or women without sufficient contraceptive care
* Patients with a known history of adhesions or a known history of peritonitis
* Patients with a known sensitivity to polyvinylalcohol and/or carboxymethylcellulose
* Simultaneous participation of the patient in another clinical trial or participation in a clinical trial within the last 30 days prior to signing the Informed consent form
* Patients with ASA \> 3 or emergency patients (including severe psychic diesease)
* Patients with ascites \> 200 ml
* Patients with peritoneal carcinosis or peritoneal dialysis
* Patients with a diagnosed peritonitis, intra-abdominal abscess or other intra-abdominal infection
* Patient with renal impairment (Creatinine \> 1.3 mg/dl)
* Patients with systemic immunosuppression (e.g. hydrocortisone \> 50mg daily \[oral/i.v.\] at any day or any equivalent dosage; other immunosuppressants like Azathioprin, Mycophenolatmofetil, Ciclosporin, Everolimus, Methotrexat, ect.), chemotherapy or radiotherapy within the last 2 weeks prior to surgery
* Surgical procedures or patient characteristics which require insertion of more than 2 intra-abdominal drainages
* Women within a pregnancy or breast-feeding mothers or women who wish to get pregnant within the next 4 months after surgery or women without sufficient contraceptive care
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Aesculap AG
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Karl-Walter Jauch, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Chirurgische Klinik und Poliklinik - Großhadern, Klinikum der Universität München
Locations
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Chirurgische Klinik und Poliklinik - Großhadern, Klinikum der Universitaet Muenchen
Munich, Bavaria, Germany
Site Status
Countries
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Germany
References
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Lang R, Baumann P, Jauch KW, Schmoor C, Weis C, Odermatt E, Knaebel HP. A prospective, randomised, controlled, double-blind phase I-II clinical trial on the safety of A-Part Gel as adhesion prophylaxis after major abdominal surgery versus non-treated group. BMC Surg. 2010 Jul 6;10:20. doi: 10.1186/1471-2482-10-20.
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BACKGROUND
Lang R, Baumann P, Schmoor C, Odermatt EK, Wente MN, Jauch KW. A-Part Gel, an adhesion prophylaxis for abdominal surgery: a randomized controlled phase I-II safety study [NCT00646412]. Ann Surg Innov Res. 2015 Sep 2;9:5. doi: 10.1186/s13022-015-0014-1. eCollection 2015.
Reference Type
RESULT
Other Identifiers
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AAG-G-H-0602
Identifier Type: -
Identifier Source: org_study_id
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