Collagen-Gentamicin Implant in the Treatment of Contaminated Surgical Abdominal Wounds
Recruitment status was Recruiting
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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 |
- 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 |
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| Contact: Julian KP Ong, FRCSEd | 63214677 | ong.kian.peng@singhealth.com.sg |
| Contact: Jit-Fong Lim, FRCS | 63214677 | lim.jit.fong@sgh.com.sg |
| Singapore | |
| Singapore General Hospital | Recruiting |
| Singapore, Singapore, 169608 | |
| Principal Investigator: Julian KP Ong, FRCSEd | |
| 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:
|
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 May 22, 2013