Tara KLamp



Icon Content Advisory: This page includes images of child patients. The TaraKLamp’s ability to do tight circumcisions can only be illustrated with reference to a child patient.



Last updated: 08 March 2014, 20:00 UTC



TaraKLamp advertisement graphic (11,070 bytes)
This is a Malaysian invention, developed by Dr. Gurchran Singh Tara Singh during the 1980s and early 1990s. It was first marketed in 1995. Gurch, as he is known to his friends, should properly be regarded as the father of the modern disposable circumcision clamp. His circumcision device is highly regarded in SE Asia and in Africa it is making inroads into the sub-Saharan market. In June 2009, Dr. Singh’s tireless work promoting safe circumcision earned him the Malaysian Medical Association’s Outstanding Public and Healthcare Services Award, a rare honour equivalent to a Lifetime Achievement Award.

As is so often the case with clever inventions, a host of similar devices soon followed in the wake of the original. Each one differs slightly, in an attempt to skate around the intellectual property rights of their competitors. Elsewhere on this website you will find descriptions of (in alphabetical order) the Ali’sKlamp, Ismail Clamp, KirveKlamp, SmartKlamp and Sunathrone devices.

The principle of operation of the Tara KLamp is illustrated by the following diagrams, based upon the manufacturer’s original publicity material dating from the 1990s:

tarasequence-1 (3065 bytes) tarasequence-2 (2056 bytes) tarasequence-3 (1927 bytes) tarasequence-4 (2886 bytes) tarasequence-5 (2923 bytes)

Once the clamp is closed, the fate of the foreskin is sealed. There’s no going back; the powerful crushing action causes irrecoverable tissue damage. In theory an option exists not to cut with a scalpel, instead leaving the condemned part of the foreskin in place to necrotise - the clamping action having totally cut off the blood supply. However, this approach is not recommended due to the possibility of the considerable quantity of dead tissue harbouring infection during the week or so until the clamp drops off naturally. Normally, a scalpel will be used to sever the foreskin a few minutes after the clamp is applied. The correct position of the cut is 2mm to 3mm clear of the distal face of the clamping ring. When marking out a circumcision using one of these clamps, it is vital to realise that the eventual scar line will form at the position of the proximal face of the clamping ring, not at the position of the scalpel cut.

Unlike the Plastibell device, which uses string to strangulate the condemned tissue, a Tara KLamp can achieve fairly tight styles of circumcision without the inner part digging into retained tissue.

The inventor claims the following benefits viz-a-viz conventional circumcision surgery:

In the years since the Tara KLamp was first marketed, a number of incremental design improvements have been made. Most notable of these is that the material used to mould the clamp has been changed. This has enabled the size of the device to be reduced without compromising on strength. Only clamps made the newer material should now be in circulation, any unused devices moulded using the old material now being past their use-by date in terms of sterility.
Tara KLamp kit as packaged (18269 bytes)
Sterilisation is by the EO process. The current grade of plastic used is not suited to sterilisation by Gamma-Ray irradiation (Cobalt 60 exposure). In common with many plastics, it goes brittle when irradiated. So, despite the environmental concerns that some people attach to the Ethylene Oxide process, the old-fashioned method prevails. Experimentation with sterilisation by ultra-high voltage electrostatic fields is in prospect, but not yet implemented.

Current clamp production is in a range of sizes from newborn to adult. From the outset, the production and marketing company TaraMedic supplied these clamps as part of a kit that also included a scalpel blade and a measuring device. This accords with the company’s original design concept, which envisaged a device useable in remote places by those with only ad-hoc training. Although a greater degree of medical expertise is now recommended, the concept of a "Field Kit" has been retained. No means of anaesthesia is included; users must organise that separately. The recommended form of anaesthesia is a Dorsal Penile Nerve Block (DPNB). For children, this can usefully be preceed by an application of a topical anaesthetic cream to dull the pain of the first injection.

On the subject of pain relief, Dr. Singh himself writes: “On discomfort, I would feel there could be some discomfort as the patient will have the device on him for a minimum of 4-5 days. However, we get feed-back that patients do not mind that, as they realize that the many benefits that they otherwise obtain, have really taken away their fears etc. and are grateful for that.”



Here are some images of adult size Tara KLamps in use:


TaraKLamp circumcision, before and after (30,340 bytes) Tara KLamp being worn (17,536 bytes)



Click on any of these thumbnails to enlarge the image. Having viewed the enlarged version, use the BACK button of your browser to return here.


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Recircumcision with a Tara KLamp


The Mk.1 Tara KLamp shown below is being applied to an adult who was previously circumcised freehand, showing that the Tara KLamp can be used to tighten a circumcision.


Adult recircumcision by Tara KLamp (13393 bytes)




Child circumcision with a Tara KLamp


The following image shows an Indonesian boy being circumcised with the latest model of Tara KLamp. Note especially the more compact size of the clamp compared with the original and the narrow necrotic ring it achieves along with a low and moderately tight style. The latching mechanism remains as secure as before, making this clamp especially suitable for use on disabled, autistic or meddlesome boys.

Tara KLamp - boy (25,009 bytes)

Photo credit : Rumah Sunatan, Jakarta



Known use


Malaysian flag (1204 bytes)       Indonesian flag (433 bytes)       Philippines flag (2293 bytes)       South Africa flag (1204 bytes)       Swaziland flag (433 bytes)       Lesotho flag (2293 bytes)

We are aware of the clamp being used in Malaysia, Indonesia, the Philippines, South Africa, Swaziland and Lesotho. This list may not be complete.



The Great KwaZulu-Natal Rumpus

CIRCLIST’s Archived News Page (2010) notes the vitriolic criticism levelled at Tara KLamp during October and early November of that year. One suggestion being circulated in the South African press was that the Forceps Guided method of adult male circumcision is preferable to the KLamp on all counts. True or false? Below, this issue is examined in detail, starting with a Question-and-Answer format to cover the basics.
Fact:  One advantage of the Tara KLamp over the standard Forceps Guided method is that it has the potential to remove a greater proportion of the inner foreskin.

Q:  Really?  Why is that so?
A:  Forceps-Guided is a "tug-&-chop" method, which inevitably leaves behind all that part of the inner foreskin that is stretched between the sulcus and the distal face of the forceps at the time of the "tug". The KLamp, on the other hand, can be positioned so as to remove almost all of the inner foreskin, far more than is attainable by any tug-&-chop method.

Q:  Why is that significant?
A:  Theory suggests that removal of a greater proportion of inner foreskin (sometimes called the "low" style of male circumcision) may confer a greater degree of protection against infection with HIV. It is, as yet, an untested hypothesis, so the Precautionary Principle should be applied pending final determination of the relationship between style and protective effect. If in doubt, go "low".

Q:  What is this theory?
A:  The primary route by which HIV enters a new host during sexual intercourse is by first binding to the receptors found on “antigen presenting cells” in the genital mucosa. Antigen presenting cells include macrophages, Langerhans cells and dendritic cells. (Szabo and Short, BMJ 2000; 320 : 1592). The densest concentrations of Langerhans cells (especially) are found in the inner foreskin and the frenulum. Therefore the optimum style of circumcision, in terms of HIV protection, is likely to be one that removes the greatest proportion of inner foreskin.

Q:  How come this has been known for ten years but not acted upon?
A:  It was first necessary to establish beyond reasonable doubt that male circumcision has any prophylactic effect. Now that’s been done, it is time to move on and refine the style of circumcisions performed in anti-HIV campaigns.

Q:  Isn’t this unfair to those already circumcised in a high style?
A:  Not entirely. A re-circumcision can convert a high style into a low one, but not the other way around. A low style cannot be made into a high one. If further research validates the style hypothesis, a catch-up can be achieved if the difference is shown to be sufficiently significant to justify it.

Q:  So what’s the overall implication?
A:  Do half of the circumcisions with the Klamp, using a deliberately low style, and half by the standard Forceps Guided method. Some years later, assess both groups for infection rates. If there is a difference that favours the low style (that’s CIRCLIST’s prediction), then commence a more rigorous RCT in order to establish ‘gold standard’ evidence.

[Based on notes of a conversation between Dr. Singh and CIRCLIST’s Editor, 04.November.2010.]

This theory also has the potential to explain why circumcision does not confer 100% protection. There are some musosal cells just inside the urethra, which no form of circumcision can ever remove. What appears to be at work here is the mathematics of probability and the number of antigen presenting cells which remain vulnerable to contact with infected body fluids from the female. In the simplest mathematical terms, the suggestion is that...
Risk = N × P

where N is the number of residual antigen presenting cells and P in the probability of any single one of those cells admitting the genetic code of the virus to the previously-uninfected host.
The chances of one HIV 'bug' attaching to one antigen presenting cell is mercifully small. Make that a million bugs and a million antigen presenting cells and the risk of one copy of the virus’s genetic code getting through (which is all it takes) is hugely greater. Removal of as many antigen presenting cells as possible lowers the total risk of "one getting through" by the greatest extent possible, and thus maximises the prophylactic effect of the circumcision.

Maybe, in the light of the above, those who suggest that the Klamp is less satisfactory than Forceps Guided on all counts might care to reconsider? It has one clear advantage: less residual inner foreskin. This in turn opens up a way of exploring whether the public health benefits of circumcision could be further enhanced by paying greater attention to the issue of style.



Criticism by the Treatment Action Campaign

In 2012, further criticism was levelled against Tara KLamp by the same South African pressure group, the Treatment Action Campaign. This related to infection rates and other adverse outcomes supposedly arising as a result of use of Tara KLamps, especially on adults. Again, the claim was made that a forceps-guided circumcision is preferable. No Circlist representative was present in Kwa-Zulu Natal to gather data on this issue first-hand, but by way of evidence that the forceps-guided approach isn’t perfect here are some photographs of adverse outcomes arising from forceps-guided guided procedures done in the same comparative trial. The makers of the Tara KLamp claim that all these problems would have been avoided had their device been used. Image captions are the comments made by Dr.Singh of Tara Medic. Use the magnifier of your browser to enlarge the images:

Sam-0025
Problems:
-
Most of the inner prepuce remains, as does a significant portion of the frenulum.
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This is an incomplete circumcision with very poor outcome. The prime objective of circumcision done as a form of HIV prophylaxis (the removal of as many Langerhans cells as possible) has not been achieved.
 
 
Sam-0222
Problems:
-
Again, most of the inner prepuce remains, as does a significant portion of the frenulum, so the prime objective has not been met.
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Additionally, the suturing technique is very poor.
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The residue of inner foreskin stretches over time; some patients thus circumcised report significant pain during sexual contact.
Sam-0567
Problems:
-
In this case only the tip of the prepuce was excised and sutured, causing painful iatrogenic phimosis.
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Again the result does not meet the prime objective of a Public Health campaign targetting the spread of HIV.
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The patient required re-circumcision including hospitalization for IV antibiotics.
Sam-0223
Problems:
-
Too great a residue of inner foreskin.
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Diathermy burn on the glans.
 
 
Sam-0570
Problems:
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Wound dehiscence.
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Too great a residue of inner foreskin.
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Excessive removal of shaft skin.
2012-03-28-088
Problems:
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Too much inner prepuce left in-situ, with oedematous swelling.
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Diathermy burn of the glans, with possibility of long-term scarring.
 
 



Tara KLamp in South Africa - The government’s viewpoint as at 29.August.2012

In late August 2012, a position statement regarding Tara KLamp was issued by the KwaZulu-Natal Health Authority and published on the central government website. It dismisses the Treatment Action Campaign’s criticisms of Dr.Singh’s device and clears the way for a ramping-up of use of this clamp throughout South Africa. Governments of other sub-Saharan countries are in consequence sending representatives to observe circumcisions done in KZN with the Tara KLamp. You can read the statement here:
http://www.info.gov.za/speech/DynamicAction?pageid=461&sid=30216&tid=81638.



Editor’s note concerning comparisons between methods of circumcision:

When comparing any of the clip-&-wear plastic circumcision devices with full surgical techniques, it must be remembered that the plastic clips significantly simplify and de-skill the procedure. Not only are training requirements greatly reduced, implying greater availability of personnel to carry out campaigns of mass circumcision, but also the requirement for an aseptic environment is largely eliminated because no open wound is created. The forceps-guided technique (particularly) involves the creation of a significant open wound, requiring sterile surroundings. The logistics of providing that environment, especially in a rural setting, cannot be overlooked by those planning large-scale provision of circumcision facilities.



Sources of further information about Tara KLamp

The manufacturer does not maintain a website at its Malaysian headquarters, but some information is available on the internet from users. Below are the contact details for supply enquiries. Note that TaraMedic will only make clamps available to qualified medical practitioners or properly constituted medical supplies wholesalers. Despite its original design concept as a device for use by "Barefoot Doctors", the Tara KLamp is not suitable for "DIY" circumcision.
TaraMedic Corporation Sdn Bhd
Technology Park Malaysia
Pusat Inkubator 3, Building 6,
1-3a Lebuhraya Puchong-Sg. Besi,
Bukit Jalil,
57000 KUALA LUMPUR
Malaysia

Tel: +603 89963667 and +603 89963668
Fax: +603 89963669




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