ClinicalTrials.gov
ClinicalTrials.gov Menu

Collagen-Gentamicin Implant in the Treatment of Contaminated Surgical Abdominal Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00977405
Recruitment Status : Terminated
First Posted : September 15, 2009
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
Novem Healthcare Pte Ltd
Information provided by (Responsible Party):
Singapore General Hospital

Brief Summary:
The investigators' hypothesis is that placement of CollatampG in the subcutaneous layer of contaminated abdominal wounds is effective prophylaxis for superficial surgical site infection (SSI). CollatampG is composed of highly purified type 1 collagen obtained from bovine tendon, which acts as a vehicle for the aminoglycoside antibiotic, gentamicin. This implant provides a high concentration of local gentamicin at the surgical wound to decrease the local microorganism load. It has been shown that if a surgical site is contaminated with > 10 to the power of 5 microorganisms per gram of tissue, the risk of infection is markedly increased. When a gastrointestinal organ is the source of pathogens, gram-negative bacilli (e.g., E. coli) are typical isolates, which are susceptible to gentamicin. Therefore, a high local concentration of gentamicin at the contaminated surgical wound provided by the CollatampG implant may prevent the local bacterial load from reaching levels high enough to cause a clinical infection.

Condition or disease Intervention/treatment Phase
Superficial Surgical Site Infection Device: Collatamp Gentamicin Implant Phase 2

Detailed Description:

Aims: To decrease the incidence of superficial surgical site infection (SSI) using a collagen -gentamicin implant (CollatampG) for patients who undergo major abdominal surgery with contaminated surgical wounds.

Hypotheses: Patients undergoing abdominal surgery with wounds classified as contaminated or dirty are at a high risk of SSI. Wounds are classified as contaminated when an operation is performed through an infected area (e.g abscess, perforated viscus or traumatic wound) that has been exposed for over 4 hours. Risk of infection in these wounds has been shown to be as high as 45 %.

Our hypothesis is that placement of CollatampG in the subcutaneous layer of contaminated abdominal wounds is effective prophylaxis for superficial SSI. CollatampG is composed of highly purified type 1 collagen obtained from bovine tendon, which acts as a vehicle for the aminoglycoside antibiotic, gentamicin. This implant provides a high concentration of local gentamicin at the surgical wound to decrease the local microorganism load. It has been shown that if a surgical site is contaminated with >10 to the power of 5 microorganisms per gram of tissue, the risk of infection is markedly increased. When a gastrointestinal organ is the source of pathogens, gram-negative bacilli (e.g., E. coli) are typical isolates, which are susceptible to gentamicin. Therefore, a high local concentration of gentamicin at the contaminated surgical wound provided by the CollatampG implant may prevent the local bacterial load from reaching levels high enough to cause a clinical infection.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Collagen-Gentamicin Implant in the Treatment of Contaminated Surgical Abdominal Wounds - A Randomized Controlled Trial
Study Start Date : September 2009
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Primary closure after standard washing of wound with chlorhexidine solution
Experimental: Collatamp G
Primary closure of wound with collatamp G in subcutaneous layer
Device: Collatamp Gentamicin Implant
Collatamp Gentamicin placed into subcutaneous layer of dirty abdominal wounds
Other Name: CollatampG




Primary Outcome Measures :
  1. Incidence of superficial surgical site infections [ Time Frame: 30 days ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients having a preoperative diagnosis of perforated viscus, perforated gastrointestinal tumour, or intraabdominal abscess (based on clinical and radiological findings), requiring abdominal surgery.
  • Patient with prolonged surgery (operative time charted > 4 hours).
  • Age 21 and above, able to understand the information regarding the study.
  • Agreeable for randomization and signed consent form.

Exclusion Criteria:

  • Patients who have known allergy to products of bovine origin or to the antibiotic, gentamicin.
  • Pregnant women or breast-feeding mothers.
  • No signed consent form.
  • Intra-operative surgical finding inconsistent with inclusion criteria (lack of evidence of intra-peritoneal sepsis or duration of surgery < 4 hours).
  • Patients having urgent abdominal surgery without indication of intra-peritoneal sepsis (such as patients with impending intestinal obstruction).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00977405


Locations
Singapore
Singapore General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
Novem Healthcare Pte Ltd
Investigators
Principal Investigator: Julian KP Ong, FRCSEd Singapore General Hospital
Study Director: Jit-Fong Lim, FRCS Singapore General Hospital

Publications of Results:
Other Publications:
Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT00977405     History of Changes
Other Study ID Numbers: Collatamp G
First Posted: September 15, 2009    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Keywords provided by Singapore General Hospital:
Wound infection
Gentamicin
Contaminated wounds

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action