Collagen-Gentamicin Implant in the Treatment of Contaminated Surgical Abdominal Wounds
Primary Purpose
Superficial Surgical Site Infection
Status
Terminated
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Collatamp Gentamicin Implant
Sponsored by
About this trial
This is an interventional prevention trial for Superficial Surgical Site Infection focused on measuring Wound infection, Gentamicin, Contaminated wounds
Eligibility Criteria
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).
Sites / Locations
- Singapore General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Collatamp G
Arm Description
Primary closure after standard washing of wound with chlorhexidine solution
Primary closure of wound with collatamp G in subcutaneous layer
Outcomes
Primary Outcome Measures
Incidence of superficial surgical site infections
Secondary Outcome Measures
Full Information
NCT ID
NCT00977405
First Posted
September 14, 2009
Last Updated
April 19, 2018
Sponsor
Singapore General Hospital
Collaborators
Novem Healthcare Pte Ltd
1. Study Identification
Unique Protocol Identification Number
NCT00977405
Brief Title
Collagen-Gentamicin Implant in the Treatment of Contaminated Surgical Abdominal Wounds
Official Title
Collagen-Gentamicin Implant in the Treatment of Contaminated Surgical Abdominal Wounds - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
Novem Healthcare Pte Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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). 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superficial Surgical Site Infection
Keywords
Wound infection, Gentamicin, Contaminated wounds
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Primary closure after standard washing of wound with chlorhexidine solution
Arm Title
Collatamp G
Arm Type
Experimental
Arm Description
Primary closure of wound with collatamp G in subcutaneous layer
Intervention Type
Device
Intervention Name(s)
Collatamp Gentamicin Implant
Other Intervention Name(s)
CollatampG
Intervention Description
Collatamp Gentamicin placed into subcutaneous layer of dirty abdominal wounds
Primary Outcome Measure Information:
Title
Incidence of superficial surgical site infections
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian KP Ong, FRCSEd
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jit-Fong Lim, FRCS
Organizational Affiliation
Singapore General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
9880419
Citation
Guzman Valdivia Gomez G, Guerrero TS, Lluck MC, Delgado FJ. Effectiveness of collagen-gentamicin implant for treatment of "dirty" abdominal wounds. World J Surg. 1999 Feb;23(2):123-6; discussion 126-7. doi: 10.1007/pl00013171.
Results Reference
background
PubMed Identifier
7925666
Citation
Poulsen KB, Bremmelgaard A, Sorensen AI, Raahave D, Petersen JV. Estimated costs of postoperative wound infections. A case-control study of marginal hospital and social security costs. Epidemiol Infect. 1994 Oct;113(2):283-95. doi: 10.1017/s0950268800051712.
Results Reference
result
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Collagen-Gentamicin Implant in the Treatment of Contaminated Surgical Abdominal Wounds
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