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Completed

NCT Number: NCT00512356

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

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.

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Key information

Conditions

Intraperitoneal Adhesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Copenhagen University Hospital, Rigshospitalet Department of Gastroenterologic Surgery, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anti-Adhesion Product

Biological

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 outcomes

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

Secondary outcomes

  1. Number of subjects with no adhesions

  2. Extent and severity of adhesions around the rectal stump

  3. Extent and severity of adhesions at the incision line

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

  5. Time to reach and free the rectal stump

  6. Safety (laboratory evaluation, recording of adverse experiences)

Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2003
Study completion
2003
First posted
Aug 7, 2007
Registry last updated
Aug 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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