A-Part® Gel as Adhesion Prophylaxis After Major Abdominal Surgery Versus a Non-treated Group (A-PART)

This study has been completed.
Sponsor:
Information provided by:
Aesculap AG
ClinicalTrials.gov Identifier:
NCT00646412
First received: March 25, 2008
Last updated: June 7, 2011
Last verified: June 2011
  Purpose

The safety of applying A-Part® Gel intra-peritoneally under the incision in order to prevent post-surgical adhesions after median laparotomy.


Condition Intervention Phase
Adhesions
Abdominal Cavity
Device: A-Part® Gel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Prospective, Randomised, Controlled, Single-blind Phase I-II Clinical Trial on the Safety of A-Part® Gel as Adhesion Prophylaxis After Major Abdominal Surgery Versus a Non-treated Group

Resource links provided by NLM:


Further study details as provided by Aesculap AG:

Primary Outcome Measures:
  • Occurrence of wound healing impairment and/or postoperative peritonitis after surgery [ Time Frame: 28 (+10) days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurrence of anastomosis leakage after surgery [ Time Frame: within 28 (+10) days ] [ Designated as safety issue: Yes ]
  • Occurrence of adverse events (AEs) and serious adverse events (SAEs) after surgery [ Time Frame: postoperative hospital stay and up to 3 months ] [ Designated as safety issue: Yes ]
  • Adhesion rates along the scar examined by ultrasound-assessment [ Time Frame: 14 days (range: day 7-14), 28 days (+10 days), 3 months (± 14 days) ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: July 2008
Study Completion Date: August 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
A-Part® Gel
Device: A-Part® Gel
10 - 20 ml of A-Part® Gel will be administered before abdominal wall closure in a standardised fashion
No Intervention: B
untreated control group

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646412

Locations
Germany
Chirurgische Klinik und Poliklinik - Großhadern, Klinikum der Universitaet Muenchen
Muenchen, Bayern, Germany, 81377
Sponsors and Collaborators
Aesculap AG
Investigators
Principal Investigator: Karl-Walter Jauch, Prof.Dr. Chirurgische Klinik und Poliklinik - Großhadern, Klinikum der Universität München
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PD Dr. Hanns-Peter Knaebel, Aesculap AG & Co. KG
ClinicalTrials.gov Identifier: NCT00646412     History of Changes
Other Study ID Numbers: AAG-G-H-0602
Study First Received: March 25, 2008
Last Updated: June 7, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Aesculap AG:
randomized, controlled, single-blind study
Adhesion Prophylaxis
Abdominal Surgery
Laparotomy, median

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014