Status:
TERMINATED
Collagen-Gentamicin Implant in the Treatment of Contaminated Surgical Abdominal Wounds
Lead Sponsor:
Singapore General Hospital
Collaborating Sponsors:
Novem Healthcare Pte Ltd
Conditions:
Superficial Surgical Site Infection
Eligibility:
All Genders
21+ years
Phase:
PHASE2
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). Collata...
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 surgic...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00977405
Start Date
September 1 2009
End Date
August 1 2013
Last Update
April 20 2018
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, 169608