NCT00977405

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

3.9 years

First QC Date

September 14, 2009

Last Update Submit

April 19, 2018

Conditions

Superficial Surgical Site Infection

Keywords

Wound infectionGentamicinContaminated wounds

Outcome Measures

Primary Outcomes (1)

  • Incidence of superficial surgical site infections

    30 days

Study Arms (2)

Control

NO INTERVENTION

Primary closure after standard washing of wound with chlorhexidine solution

Collatamp G

EXPERIMENTAL

Primary closure of wound with collatamp G in subcutaneous layer

Device: Collatamp Gentamicin Implant

Interventions

Collatamp Gentamicin ImplantDEVICE

Collatamp Gentamicin placed into subcutaneous layer of dirty abdominal wounds

Also known as: CollatampG
Collatamp G

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (2)

  • 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.

    PMID: 9880419BACKGROUND

  • 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.

    PMID: 7925666RESULT

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Julian KP Ong, FRCSEd

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

  • Jit-Fong Lim, FRCS

    Singapore General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2009

First Posted

September 15, 2009

Study Start

September 1, 2009

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

April 20, 2018

Record last verified: 2018-04

Locations

SG(1)