GB2232873A - Clothing system - Google Patents

Abstract

A clothing system for use by surgical personnel, comprising one or more garments presenting a substantial barrier to passage of skin particles released by the body, the barrier being effected by virtue of a tight-weave construction of synthetic material having an appropriately small pore size. The clothing system may comprise a long-sleeved theatre suit, Fig. 1 or a short-sleeved theatre suit (Fig. 2), a hood (Fig. 3) and a gown (Figs. 4 & 5) worn over the hood and suit. Gloves and a mask are also worn. <IMAGE>

Description

"Clothina System" This invention relates to a clothing system.

The problem associated with the release of skin particles, particularly those containing bacteria from the human body, is well known in the context of contamination of operating theatre environments. Such skin particles from operating theatre staff can come into contact with the exposed area of a patient being operated on, with consequent danger of infection. This can be particularly serious in orthopaedic surgery in view of the severe effects of bone infection.

It has previously been proposed to clad operating theatre staff in gowns, hoods and masks which cover all of the exposed skin, and to apply to the internal space between the gown and the body an air pump to provide a continuous negative air pressure in the space, thereby withdrawing skin particles to the pump before they can escape into the environment. The gown and hood are generally of cotton which is washed and steam sterilised for re-use.

Modifications of this system have also been proposed in which the hood and mask are dispensed with and the gown is gathered at the neck to form a restricted opening, in order that the wearer may be free to use optical instruments which would be difficult to apply with a mask in place. This results in a slight decrease in the effectiveness of the arrangement.

While such clothing systems do indeed limit the amount of contamination by skin particles they are cumbersome and very uncomfortable to wear, even in the absence of hood and mask.

According to the present invention there is provided a clothing system for use by surgical personnel, comprising one or more garments presenting a substantial barrier to passage of skin particles released by the body, the barrier being effected by virtue of a tight-weave construction of synthetic material having an appropriately small pore size.

The garment will be generally selected based on the task to be performed by the wearer.

Preferably the pore size of the garment, which may be a theatre suit, is less than 40 microns radius, most preferably less than 35 microns.

The clothing system preferably comprises a plurality of garments although a single layer of garment presenting said barrier may suffice. For non-sterile personnel, in order to comply with existing clothing conventions, the system may comprise a theatre suit of trousers and long- or short-sleeved shirt, a hood and a mask. The theatre suit preferably has closures at the neck, arms and lower body portion of the shirt and at the top and ankles of the trousers. The hood preferably overlaps the neck closure of the shirt.

For sterile personnel, in order to comply with existing clothing conventions, the system may comprise a theatre suit as described above, a hood, mask and gown. The gown preferably has closures at the neck and wrist, and preferably wraps around at the back sealing the opening. The hood preferably overlaps the neck closure of the shirt of the theatre suit, and the gown preferably extends over the overlapping portion of the hood.

Gloves may be worn on the hands, preferably overlapping the cuffs of the gown, and a mask may be worn over part or all of the exposed portion of the face.

The sleeves of the gown preferably have stitched seams along the top instead of along the underside in order to reduce the likelihood of fluid penetrating the sleeves through the seam in use.

The sleeves and front of the gown may in some cases be of multiple layer in very wet surgical procedures or where the surgeon is likely to have instruments pressed against the front of the gown, in order to present an effective barrier to fluid penetration.

It is advisable to use for the theatre suit fabric which can withstand many washing cycles without substantial deterioration in its barrier properties.

An effective fabric is that sold under the Trade Mark RANSAL anti-static fabric which is a tight weave of polyester. RANSAL anti-static fabric is comfortable to wear next to the skin and is therefore highly effective for use as a theatre suit in accordance with the invention.

The gown may be of even tighter-weave material such for example as ROTECNO (Trade Mark) Medical Fabric.

An embodiment of the invention will now be described by way of example with reference to the accompanying drawings, in which: Fig. 1 shows a long-sleeved theatre suit of the invention for non-sterile personnel; Fig. 2 shows a short-sleeved theatre suit of the invention for sterile or non-sterile personnel; Fig. 3 shows a hood of the invention worn in conjunction with the suit of Fig. 1 with an insert showing a portion of the rear of the hood; Fig. 4 shows a gown of the invention worn over the hood of Fig. 3 and the theatre suit of Fig. 2; Fig. 5 shows an upper part of the outfit of Fig. 4 from the rear.

Referring to Fig. 1, the non-sterile personnel theatre suit of this embodiment of the invention comprises a shirt portion 2 and trousers 4, all being made of RANSAL antistatic fabric of tight-weave polyester construction having a pore radius of from 27 to 32 microns, average 28 microns and an air permeability of 14.4 cc/cm2 sec at 0.98 mbar in accordance with British Standard BS 5636. The shirt 2 has knitted closures 6 at the wrist and 8 at the neck.

The trousers 4 have a waist closed by a tie (not shown) and knitted closures 10 at the ankles.

The sterile personnel theatre suit of Fig. 2 is produced from RANSAL antistatic fabric and the trousers 12 are of generally similar design to those of Fig. 1.

The shirt 14 however is of short-sleeve form with smaller knitted closure areas 16, 18, at the neck and arms. A knitted closure 20 is also provided around the bottom edge of the shirt.

Referring now to Fig. 3, the hood 22 covers all of the head with the exception of an opening 24 revealing only the eyes, nose and mouth of the wearer. The hood is of RANSAL antistatic fabric and is held closed by elasticated knitted fabric at 26. The hood 22 is adjustable in fit by means of an elasticated inner panel 28 at the back of the neck portion (Fig. 3 insert).

The hood 22 in use overlies the upper part of the shirt 2 of the long-sleeved theatre suit, or the upper part of the shirt 14 of the short-sleeved theatre suit.

Figs 4 and 5 illustrate the outer appearance of a complete clothing system of the invention. The gown 30 is a one-piece garment of ROTECNO (Trade Mark) Medical Fabric having a pore size radius of from 15 to 18 microns, average 16 microns, and an air permeability of 1.98 cc/cm2 sec at 0.98 mbar in accordance with British Standard BS 5636. The gown 30 which extends from the wearer's neck, where it encloses the lower part of the hood 22, to below the knees (not shown). The gown 30 is long-sleeved and completely covers the short-sleeved theatre suit, having knitted closures 32 at the wrists.

The neck of the gown 30 is closed by means of a tie 34 at the neck which secures a wrap-around panel (Fig. 5), and a tie 36 at the waist (Fig. 4).

Rubber boots 38 are worn, overlapped by the gown 30, and a face mask 40 covers the nose and mouth of the wearer. Goggles or a full mask may be worn, and gloves (not shown) can be worn on the hands, overlapping and enclosing the knitted closures 32.

The clothing system of this embodiment of the invention is very comfortable to wear and provides an excellent barrier to passage of skin particles (generally of 7 to 20 microns particle size) without the need for any internal air extraction system underneath the gown.

The clothing system of this embodiment was tested in full and in part in comparison with standard cotton gowns and scrub suits, with disposable paper systems and with ordinary day clothes.

Test Apparatus The tests were carried out in a body box, which is essentially a large box big enough for a person to stand upright and do slight exercises. On top of the box is a hepafilter, so that when the box is closed and air is passed through the hepafilter into the box, it becomes a controlled environment (like a mini operating theatre).

On the wall of the box is a bacterial counter sampling connection which draws samples of air from the box.

When the box is empty the bacterial counter gives a very low reading. When a person is in the box with the door closed, the bacterial counter gives a count of the number of bacteria the person is shedding. The bacterial filtration properties of the clothing will vary with different types of clothing.

Results The tests were carried out in a single day using one person so that the rate of bacterial shedding is kept as constant as possible.

The person wore the various test garments in the test in the body box. To stimulate the shedding of bacteria containing particles, a slight exercise was performed which consisted of stepping on to a small box to the beat of a metronome.

The bacterial count was measured and once it settled to a constant level this reading was recorded.

The following types of clothing were tested.

1. "Standard cotton shirt, trousers and disposable cap and mask". This is the standard scrub suit as issued by Shropshire Health Authority Hospitals.

2. "As above and standard cotton gown and gloves".

This is the standard gown (balloon cloth) as issued by Shropshire Health Authority Hospitals.

3. "Day clothes". This is ordinary day clothes of shirt and trousers.

4. "Barrier 450 shirt, trousers etc". This is single use disposable theatre clothing.

5. "As above and Molnycke gown". This is when all disposable items are used.

6. "As above and disposable 450 yoke". This is use of all disposable items with disposable hood.

7. "Lojigma shirt, trousers and disposable cap and mask". This is the Lojigma short sleeve theatre suit produced from Ransal antistatic fabric.

8. "As above and Lojigma gown". This is the Lojigma gown produced from Rotecno (Trade Mark) medical fabric.

9. "As above and disposable yoke". This is the Lojigma theatre clothing system with a disposable hood.

The results were as follows: Colony Forming Units/ft3 of Air 1. Standard cotton scrub suit and disposable cap and mask 66 2. As 1 and standard cotton gown and gloves 57 3. Day clothes 63 4. Disposable scrub suit and disposable cap and mask 18 5. As 4 plus disposable gown 19 6. As 5 plus disposable neck cover 8 7. Short-sleeved theatre suit of the invention and disposable cap and mask 12 8. As 7 and gown of the invention and gloves 7 9. As 8 and disposable neck cover 5 It can be seen that standard cotton operating room clothes are no more effective in retaining skin-bacteria than ordinary everyday clothes.

Barrier 450 disposable operating room clothes and Lojigma designs reduce air contamination by almost 5-fold and 6-fold respectively.

In further tests the volunteer exercised in a standardised manner in an exercise chamber dressed in various operating room clothes. When the volunteer simulated a scrubbed team member he wore head covering, mask, operating room boots and sterile gloves. A Casella slit sampler extracted air for 2 minutes from the exercise chamber at a rate of 700 litres per minute onto Nutrient agar plates which were then incubated aerobically for 18 hours at 370C and for a further 24 hours at room temperature. Colony Forming Units (CFU's) were counted mechanically and the results expressed in CFU's per ft3 of air.

CFU's/ft3 RANGE MEDIAN Cotton suit, ie 50 22-73 60 shirt & trousers Cotton suit & 69 22-114 80 cotton gown Ransal suit, 10 5-19 7 (Rotecno) Ransal suit & 10 6-15 9 Rotecno gown Ransal suit, shirt 6 5-9 6 & Rotecno gown & BR< Ransal Yoke These results are impressive and match Barrier 450 in effectiveness as a retainer of shed skin particles.

Test results on bacterial sampling in an orthopaedic theatre at different sites and stages of the operation using various clothing systems are now given: (a) Surgeon wearing ROTECNO (Trade Mark) gown, Ransal short sleeved shirt, Ransal hood and Ransal trousers, and a disposable face mask.

Plate Procedure Count Per Count Number 7000L Per m 1 empty theatre:- 49 7 outside canopy 2 incision and removal 2 < 1 of broken bone: wound site 3 incision and removal 1 < 1 of broken bone: trolley 4 fitting prosthesis:- Nil Nil wound site 5 fitting prosthesis:- Nil Nil trolley Clothing:- Rotecno Plate Procedure Count Per Count Number 7000L Per m 1 knife to skin:- 4 < 1 wound 2 knife to skin:- 1 < 1 trolley 3 trimming bone, Nil Nil fitting prosthesis : - wound 4 trimming bone, 2 < 1 fitting prosthesis:- trolley 5 connecting prosthesis 2 < 1 and stitching:- wound Plate Procedure Count Per Count Number 7000L Per m 1 outside canopy 33 5 pre-operation 2 knife to skin:- 1 < 1 wound site 3 fitting prosthesis:- 5 < 1 wound site 4 knife to skin:- 3 < 1 trolley 5 fitting prosthesis 1 < 1 trolley Plate Procedure Count Per Count Number 7000L Per m 1 knife to skin:- 2 < 1 wound site 2 knife to skin:- 1 < 1 trolley 3 trimming bone:- 5 < 1 wound 4 trimming bone:- 6 < 1 trolley 5 background count 122 17 outside canopy Plate Procedure Count Per Count Number 7000L Per m 1 knife to skin:- Nil Nil wound site 2 knife to skin:- 1 < 1 trolley 3 fitting prosthesis:- 2 < 1 wound site 4 fitting prosthesis:- 1 < 1 trolley 5 relocation of joint::- 1 < 1 (b) Surgeon wearing space suit and cotton or polyester/cotton scrub suit.

Plate Procedure Count Per Count Number 7000L Per m 1 knife to skin 4 < 1.0 2 reaming 7 1.0 3 fitting cup/ 2 < 1.0 reaming femur 4 cementing/ 0 0 stitching 5 outside canopy 49 7 Machine (2) Trolley Plate Procedure Count Per Count Number 7000L Per m 1 knife to skin 1 < 1.0 2 reaming 2 < 1.0 3 fitting cup/ 0 0 reaming femur 4 cementing/stitching 26 3.7 Machine (1) wound site Plate Procedure Count Per Count Number 7000L Per m 1 knife to skin:- 1 < 1 wound site 2 Reaming:- 3 < 1 wound site 3 knife to skin:- 3 < 1 trolley 4 Reaming trolley 4 < 1 Plate Procedure Count Per Count Number 7000L Per m 1 outside air 207 31 canopy, pre-operation 2 knife to skin:- 2 < 1 wound site 3 sawing and fitting:- 2 < 1 wound site 4 cementing and suturing:- 1 < 1 wound site 5 knife to skin:- 8 1 trolley 6 sawing and fitting: :- 7 1 trolley 7 cementing and suturing:- Nil Nil trolley (c) Surgeon wearing disposable gown and cotton or polyester cotton scrub suit Plate Procedure Count Per Count Number 7000L Per m 1 knife to skin:- 3 < 1 wound site 2 knife to skin:- Nil Nil trolley 3 fitting prosthesis:- 3 < 1 wound site 4 fitting prosthesis:- 2 < 1 trolley Modifications and improvements may be incorporated without departing from the scope of the invention.

Claims (17)

1. A clothing system for use by surgical personnel, comprising one or more garments presenting a substantial barrier to passage of skin particles released by the body, the barrier being effected by virtue of a tight-weave construction of synthetic material having an appropriately small pore size.

2. A clothing system as claimed in Claim 1, wherein the pore size of the garment is less than 40 microns radius.

3. A clothing system as claimed in Claim 1, wherein the pore size of the garment is less than 35 microns radius.

4. A clothing system as claimed in any of the preceding Claims, wherein a plurality of garments is provided.

5. A clothing system as claimed in any of Claims 1 to 3, wherein a single layer of garment is provided.

6. A clothing system as claimed in Claim 4, wherein the clothing system comprises a theatre suit of trousers and long- or short-sleeved shirt, a hood and a mask.

7. A clothing system as claimed in Claim 6, wherein the theatre suit has closures at the neck, arms and lower body portion of the shirt and at the top and ankles of the trousers.

8. A clothing system as claimed in Claim 6 or Claim 7, wherein the hood overlaps the neck closure of the shirt.

9. A clothing system as claimed in any of Claims 6 to 8, wherein the clothing system comprises a gown.

10. A clothing system as claimed in Claim 9, wherein the gown has closures at the neck and wrist, and wraps around at the back sealing the opening.

11. A clothing system as claimed in Claim 9 or Claim 10, wherein the hood overlaps the neck closure of the shirt of the theatre suit, and the gown extends over the overlapping portion of the hood.

12. A clothing system as claimed in any of Claims 9 to 11, wherein gloves are worn on the hands overlapping the cuffs of the gown, and a mask is worn over part or all of the exposed portion of the face.

13. A clothing system as claimed in any of Claims 9 to 12, wherein the sleeves of the gown have stitched seams along the top instead of along the underside in order to reduce the likelihood of fluid penetrating the sleeves through the seam in use.

14. A clothing system as claimed in any of Claims 9 to 13, wherein the sleeves and front of the gown are of multiple layer.

15. A clothing system as claimed in any of the preceding Claims, wherein fabric which can withstand many washing cycles without substantial deterioration in its barrier properties is used.

16. A clothing system as claimed in any of the preceding Claims, wherein the tight-weave material used is ROTECNO (Trade Mark) Medical Fabric or RANSAL (Trade Mark) antistatic fabric.

17. A clothing system substantially as hereinbefore described with reference to the accompanying drawings.