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Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions

Primary Purpose

Intraperitoneal Adhesions

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Anti-Adhesion Product

About this trial

This is an interventional prevention trial for Intraperitoneal Adhesions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent obtained from the subject or the subject's legally authorized representative prior to study entry
Male or female subjects > 18 years of age
Subjects undergoing abdominal surgery with the possibility that a rectal stump would remain due to one or more of the following reasons: inflammatory bowel diseases, neoplasm, colon diverticulitis, colonic obstruction, colon polyposis, peritoneal trauma, fistula, incontinence, or other reasons
Subjects for whom a second abdominal surgery is planned within approximately eight months of the first surgical procedure.

Exclusion Criteria:

Pre operative:

Pregnancy and lactation period
Subjects concurrently participating in another clinical trial with a drug or a device
Subjects who have participated in a clinical trial with a drug or a device within 30 days prior to this study
Subjects who have had abdominal/pelvic surgery within six months prior to this study
Subjects who have received or will receive (approximately within the next eight months) abdominal/pelvic irradiation

Intra operative:

Subjects with peritonitis
Subjects with gastrointestinal metastatic cancer, or cancer growing per continuitatem into surrounding tissues
Subjects treated with hemostatic agents (e.g. fibrin sealant, collagen, oxidized cellulose) during the first surgery
Subjects treated with adhesion prevention agents other than the Anti-Adhesion Product (AAP) (e.g. Intergel® Adhesion Prevention Solution, Seprafilm® Membrane) during the first surgery
Subjects with major fecal contamination needing an abdominal lavage during the first surgery

Sites / Locations

Copenhagen University Hospital, Rigshospitalet Department of Gastroenterologic Surgery
Odense University Hospital, Surgical Gastroenterology Department
Klinika Chirurgii Ogolnej Onkologicznej i Klatiki Piersiowej CSK WAM
Im. Marii Sklodowskiej-Curie, Centrum Onkologii-Instytut
Göteborg University, Department of Surgery, Colorectal Unit
Söder Sjukhuset, Department of Surgery
Uddevalla Sjukhus, Kirurg Kliniken

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Investigational product group

Control group

Arm Description

Anti-Adhesion Product was applied to the rectal stump and the incision line. Like in the control group, surgical measures to prevent adhesions were also taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves.

Only surgical measures to prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. No specific additional treatment was applied.

Outcomes

Primary Outcome Measures

Incidence of adhesions around the rectal stump and/or incision line

Secondary Outcome Measures

Number of subjects with no adhesions

Extent and severity of adhesions around the rectal stump

Extent and severity of adhesions at the incision line

Incidence, extent and severity of adhesions at sites other than the rectal stump and incision line

Time to reach and free the rectal stump

Safety (laboratory evaluation, recording of adverse experiences)

Full Information

NCT ID

NCT00512356

First Posted

August 6, 2007

Last Updated

August 3, 2017

Sponsor

Baxter Healthcare Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00512356

Brief Title

Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions

Official Title

Study to Evaluate the Efficacy and Safety of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

December 2000 (undefined)

Primary Completion Date

February 25, 2003 (Actual)

Study Completion Date

April 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of this study was to evaluate the efficacy of the Anti-Adhesion Product (AAP) in preventing or reducing post-operative adhesion formation and re-formation in a subject population having abdominal surgery and being left with a rectal stump and a temporary stoma from a first procedure and scheduled for a laparoscopy/ laparotomy as a second procedure in the normal treatment of the subjects' disease. In both study groups, surgical measures to prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. In the investigational product group, AAP was applied to the rectal stump and the incision line while no specific additional treatment was applied in the control group. The surgeon assessed preexisting adhesions during the first surgery. Newly developed and re-formed adhesions were evaluated during the second surgery by a surgeon or assistant who did not know the result of randomization. The safety of the study drug was also monitored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intraperitoneal Adhesions

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Investigational product group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Only surgical measures to prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. No specific additional treatment was applied.

Intervention Type

Biological

Intervention Name(s)

Anti-Adhesion Product

Intervention Description

Anti-Adhesion Product (AAP) is a biological two-component product of human origin. The components of AAP are lyophilized Anti-Adhesion Protein Concentrate (AAPC), containing fibrinogen, lyophilized Thrombin Concentrate (TC) and the respective diluents for the reconstitution of the components.

Primary Outcome Measure Information:

Title

Incidence of adhesions around the rectal stump and/or incision line

Secondary Outcome Measure Information:

Title

Number of subjects with no adhesions

Title

Extent and severity of adhesions around the rectal stump

Title

Extent and severity of adhesions at the incision line

Title

Incidence, extent and severity of adhesions at sites other than the rectal stump and incision line

Title

Time to reach and free the rectal stump

Title

Safety (laboratory evaluation, recording of adverse experiences)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent obtained from the subject or the subject's legally authorized representative prior to study entry Male or female subjects > 18 years of age Subjects undergoing abdominal surgery with the possibility that a rectal stump would remain due to one or more of the following reasons: inflammatory bowel diseases, neoplasm, colon diverticulitis, colonic obstruction, colon polyposis, peritoneal trauma, fistula, incontinence, or other reasons Subjects for whom a second abdominal surgery is planned within approximately eight months of the first surgical procedure. Exclusion Criteria: Pre operative: Pregnancy and lactation period Subjects concurrently participating in another clinical trial with a drug or a device Subjects who have participated in a clinical trial with a drug or a device within 30 days prior to this study Subjects who have had abdominal/pelvic surgery within six months prior to this study Subjects who have received or will receive (approximately within the next eight months) abdominal/pelvic irradiation Intra operative: Subjects with peritonitis Subjects with gastrointestinal metastatic cancer, or cancer growing per continuitatem into surrounding tissues Subjects treated with hemostatic agents (e.g. fibrin sealant, collagen, oxidized cellulose) during the first surgery Subjects treated with adhesion prevention agents other than the Anti-Adhesion Product (AAP) (e.g. Intergel® Adhesion Prevention Solution, Seprafilm® Membrane) during the first surgery Subjects with major fecal contamination needing an abdominal lavage during the first surgery

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Baxter BioScience Investigator, MD

Organizational Affiliation

Baxter Healthcare Corporation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Copenhagen University Hospital, Rigshospitalet Department of Gastroenterologic Surgery

City

Copenhagen

ZIP/Postal Code

2120

Country

Denmark

Facility Name

Odense University Hospital, Surgical Gastroenterology Department

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Klinika Chirurgii Ogolnej Onkologicznej i Klatiki Piersiowej CSK WAM

City

Warsaw

ZIP/Postal Code

00 909

Country

Poland

Facility Name

Im. Marii Sklodowskiej-Curie, Centrum Onkologii-Instytut

City

Warsaw

ZIP/Postal Code

02 781

Country

Poland

Facility Name

Göteborg University, Department of Surgery, Colorectal Unit

City

Gothenburg

ZIP/Postal Code

416 85

Country

Sweden

Facility Name

Söder Sjukhuset, Department of Surgery

City

Stockholm

ZIP/Postal Code

118 83

Country

Sweden

Facility Name

Uddevalla Sjukhus, Kirurg Kliniken

City

Uddevalla

ZIP/Postal Code

451 80

Country

Sweden

12. IPD Sharing Statement

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Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions

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