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

NCT00977405 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-04-20

No results posted yet for this study

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.

Conditions

  • Superficial Surgical Site Infection

Interventions

DEVICE

Collatamp Gentamicin Implant

Collatamp Gentamicin placed into subcutaneous layer of dirty abdominal wounds

Sponsors & Collaborators

  • Novem Healthcare Pte Ltd

    collaborator UNKNOWN

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Julian KP Ong, FRCSEd · Singapore General Hospital

  • Jit-Fong Lim, FRCS · Singapore General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00977405 on ClinicalTrials.gov