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

September 8, 2015 updated by: Aesculap AG

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • Muenchen, Bayern, Germany, 81377
        • Chirurgische Klinik und Poliklinik - Großhadern, Klinikum der Universitaet Muenchen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of wound healing impairment and/or postoperative peritonitis after surgery
Time Frame: 28 (+10) days
28 (+10) days

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of anastomosis leakage after surgery
Time Frame: within 28 (+10) days
within 28 (+10) days
Occurrence of adverse events (AEs) and serious adverse events (SAEs) after surgery
Time Frame: postoperative hospital stay and up to 3 months
postoperative hospital stay and up to 3 months
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)
14 days (range: day 7-14), 28 days (+10 days), 3 months (± 14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Investigators

  • Principal Investigator: Karl-Walter Jauch, Prof.Dr., Chirurgische Klinik und Poliklinik - Großhadern, Klinikum der Universität München

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

March 25, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (ESTIMATE)

March 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 9, 2015

Last Update Submitted That Met QC Criteria

September 8, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-G-H-0602

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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