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

NCT ID: NCT00977405

Last Updated: 2018-04-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-08-31

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.

Conditions

Superficial Surgical Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control

Primary closure after standard washing of wound with chlorhexidine solution

Group Type: NO_INTERVENTION

No interventions assigned to this group

Collatamp G

Primary closure of wound with collatamp G in subcutaneous layer

Group Type: EXPERIMENTAL

Collatamp Gentamicin Implant

Intervention Type: DEVICE

Collatamp Gentamicin placed into subcutaneous layer of dirty abdominal wounds

Interventions

Collatamp Gentamicin Implant

Collatamp Gentamicin placed into subcutaneous layer of dirty abdominal wounds

Intervention Type: DEVICE

Other Intervention Names

CollatampG

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.

• Patients having urgent abdominal surgery without indication of intra-peritoneal sepsis (such as patients with impending intestinal obstruction).

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novem Healthcare Pte Ltd

UNKNOWN

Sponsor Role: collaborator

Singapore General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julian KP Ong, FRCSEd

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Jit-Fong Lim, FRCS

Role: STUDY_DIRECTOR

Singapore General Hospital

Locations

Singapore General Hospital

Singapore, , Singapore

Countries

Singapore

References

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.

Reference Type: BACKGROUND

PMID: 9880419 (View on PubMed)

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.

Reference Type: RESULT

PMID: 7925666 (View on PubMed)

Other Identifiers

Collatamp G

Identifier Type: -

Identifier Source: org_study_id