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Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
not reported
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Brief summary of experimental data, performed to non-standard methods.

Data source

Reference
Reference Type:
publication
Title:
Tissue reactions to tantalum gauza and stainless steel gauze an experimental comparison
Author:
Koontz AR, Kimberly RC
Year:
1953
Bibliographic source:
Annals of Surgery, Volume 137, Number 6, June 1953, p833-842

Materials and methods

Type of study / information:
Paper detailing experimental results from a study in which dogs were implanted with tantalum and stainless steel gauzes to determine their suitability for use in the surgical cure of hernias in humans.
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Approximately two inches of the rectus sheath and muscle on each side were resected through separate right and left rectus incisions in each of 76 dogs. The defect on the right was repaired by suturing in a piece of tantalum gauze, using one black silk suture in each corner of the gauze. On the left side the defect was repaired by similarly suturing in a piece of stainless steel gauze. On each side the subcutaneous tissue was closed with fine black silk, interrupted, and the skin with fine black silk, continuous. These animals were sacrificed at periods of time after operation varying from one week to 33 weeks. When animals were sacrificed, the site of each implantation was carefully observed and findings recorded.

In a follow-up study 27 dogs were treated in the same way only this time, all of the experiments were conducted in an entirely non-sterile fashion. Instruments were not sterilised and instruments, gowns and gloves were purposely contaminated. Cat gut was used to suture the materials in place. In this experiment, the average time between operation and autopsy was approximately 2 months.
GLP compliance:
not specified
Remarks:
(not reported)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): tantalum gauze

Results and discussion

Any other information on results incl. tables

Sterile experiment

In almost every instance, it was impossible to pull the tantalum gauze away from the surrounding tissues. Furthermore, there was a large amount of fibrosis visible around the tantalum gauze. Infection was seen to occur in 5 instances.

Non-sterile experiment

While all the wounds were infected and suppurated to start with, the infection cleared up in varying lengths of time and good healing took place without sinus formation. There were two cases in which infection persisted beyond time of sacrifice. Inspite of the fact that wounds were infected, excellent infiltration of fibrous tissue took place and the wounds healed nicely.

Applicant's summary and conclusion

Conclusions:
It was concluded that the experiments outlined that tantalum gauze had at least some advantages over stainless steel gauzes in hernia repair. More fibrosis was observed through and around the tantalum gauzes than around the stainless steel gauzes. It was found to be impossible to pull tissues away from tantalum gauze, so firmly were they intermingled with it and so tightly did they cling to it.
Executive summary:

In an experiment in which dogs were implanted with tantalum and stainless steel gauzes to determine their suitability for use in the surgical cure of hernias in humans it was found that tantalum gauze had at least some advantages over stainless steel gauzes in hernia repair.

During the study approximately two inches of the rectus sheath and muscle on each side were resected through separate right and left rectus incisions in each of 76 dogs. The defect on the right was repaired by suturing in a piece of tantalum gauze, using one black silk suture in each corner of the gauze. On the left side the defect was repaired by similarly suturing in a piece of stainless steel gauze. On each side the subcutaneous tissue was closed with fine black silk, interrupted, and the skin with fine black silk, continuous. These animals were sacrificed at periods of time after operation varying from one week to 33 weeks. When animals were sacrificed, the site of each implantation was carefully observed and findings recorded.

In a follow-up study 27 dogs were treated in the same way only this time, all of the experiments were conducted in an entirely non-sterile fashion. Instruments were not sterilised and instruments, gowns and gloves were purposely contaminated. Cat gut was used to suture the materials in place. In this experiment, the average time between operation and autopsy was approximately 2 months.

Under the conditions of the study, it was impossible to pull the tantalum gauze away from the surrounding tissues. Furthermore, there was a large amount of fibrosis visible around the tantalum gauze. Tantalum was also seen to exhbit a healing effect in the non-sterile experiment as, in most cases, the infection cleared up in varying lengths of time and good healing took place without sinus formation. There were two cases in which infection persisted beyond time of sacrifice. Inspite of the fact that wounds were infected, excellent infiltration of fibrous tissue took place and the wounds healed nicely.