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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Singapore General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Novem Healthcare Pte Ltd
Information provided by:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT00977405
First received: September 14, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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 Intervention Phase
Superficial Surgical Site Infection
Device: Collatamp Gentamicin Implant
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Collagen-Gentamicin Implant in the Treatment of Contaminated Surgical Abdominal Wounds - A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Incidence of superficial surgical site infections [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: September 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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).
  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: NCT00977405

Contacts
Contact: Julian KP Ong, FRCSEd 63214677 ong.kian.peng@singhealth.com.sg
Contact: Jit-Fong Lim, FRCS 63214677 lim.jit.fong@sgh.com.sg

Locations
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Principal Investigator: Julian KP Ong, FRCSEd         
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
  More Information

Publications:
Responsible Party: Lynn Teo, Novem Healthcare Pte Ltd
ClinicalTrials.gov Identifier: NCT00977405     History of Changes
Other Study ID Numbers: Collatamp G
Study First Received: September 14, 2009
Last Updated: September 14, 2009
Health Authority: Singapore: Domain Specific Review Boards

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

Additional relevant MeSH terms:
Infection
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014