Superficial Surgical Site Infection Clinical Trial
Official title:
Collagen-Gentamicin Implant in the Treatment of Contaminated Surgical Abdominal Wounds - A Randomized Controlled Trial
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00975377 -
Clipping Versus No Hair Removal and the Risk of Surgical Site Infections
|
N/A |