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

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.

Study Overview

• Status: Terminated
• Conditions: Superficial Surgical Site Infection
• Intervention / Treatment: Device: Collatamp Gentamicin Implant

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: CollatampG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of superficial surgical site infections	30 days

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Collaborators: Novem Healthcare Pte Ltd
• Investigators: Principal Investigator: Julian KP Ong, FRCSEd, Singapore General Hospital; Study Director: Jit-Fong Lim, FRCS, Singapore General Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: September 14, 2009
• First Submitted That Met QC Criteria: September 14, 2009
• First Posted (Estimate): September 15, 2009

Study Record Updates

• Last Update Posted (Actual): April 20, 2018
• Last Update Submitted That Met QC Criteria: April 19, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Wound infection; Gentamicin; Contaminated wounds
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Surgical Wound Infection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Gentamicins
• Other Study ID Numbers: Collatamp G