Collagen-Gentamicin Implant in the Treatment of Contaminated Surgical Abdominal Wounds
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|ClinicalTrials.gov Identifier: NCT00977405|
Recruitment Status : Terminated
First Posted : September 15, 2009
Last Update Posted : April 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Superficial Surgical Site Infection||Device: Collatamp Gentamicin Implant||Phase 2|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
- Incidence of superficial surgical site infections [ Time Frame: 30 days ]
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
|Singapore General Hospital|
|Singapore, Singapore, 169608|
|Principal Investigator:||Julian KP Ong, FRCSEd||Singapore General Hospital|
|Study Director:||Jit-Fong Lim, FRCS||Singapore General Hospital|