Protocol Trial Chemspunge® and Verihesive Sorbsan.

Protocol Evaluation of Chemspunge® Wound Dressing in the treatment of open wounds.
A JOHNSON
District Infection Control Officer
Darling Health Authority

PRINCIPAL INVESTIGATER.
N.N.

SPONSOR:- BRITCAIR LIMITED
Gordon House, Gordon Road
Aldershot, Hants Go 11 1LD.
AND SORBSAN (STERISEAL LTD)

Comparative Trail between Chemspunge® Wound Dressings AND VERIHESIVE SORBSAN
Comparative trials have been held for hydro gels,  hydrocolloids,  polyurethane foams and semi-permeable adhesive films.
Thirty-two patients were recruited to the trial.  Wound healing of venous leg ulcers.

Dr.
Pharma-Consulting
Grunwalderweg 28g
8024 Oberhaching

Susan Jay
Clinical Research Manager
Gordon Road
Aldershot, Hants GU 11 11d
Tel: 0044-282-343210

1. INTRODUCTION
Chemspunge® Wound Dressings are presented in the form of a white non-woven adsorbent pad,  or in the form of "rope";  the latter is designed specifically for packing wound cavities.
Chemspunge® Wound Dressings consists of a hydro-phallic formula,  silica gel or anhydrous calcium chloride and PVD Medical Sodium Chloride a preferred wound treatment composition and various forms of wound dressing structured to prevent it from sticking to wounds.
To control wound temperature.
This provides an effective healing environment and allows easy pain free removal.

The white felt is manufactured from cotton fluff a natural organic tissue of the highest quality derived from natural cotton approved by APPTEC LABORATORIES - U.S.A. of Medical Devices for:
                Irritation and delayed-type hyper sensitivity.
                Cytotixicity in Vitro methods.
                Systemic toxicity, pp 267 - 273.
                Irritation and delayed-type Hypersensitivity.
                Part 10 tests for irritation and delayed-type hypersensitivity pp. 15 - 18 for testing Guinea Pyp. Ref. 10 993-5 : 1999.
                Biological Evaluation test for Cytotoxicity in vitro methods.
                This both provides an effective healing environment and allows easy pain free removal.
                The present study is designed to confirm the already available data on efficacy and safety in comparison with varihesive.

2. OBJECTIVES AND BENEFITS / RISK CONSIDERATIONS
It is the aim of this study to define the place of Chemspunge® Wound Dressings in comparison with Varihesive in wound healing of venous leg ulcers foot ulcers arterial origin Neuropathic origin and pressure approved by Ethical consideration.

STUDY REPORT
Thirty-two patients were recruited to trial (see table 1, wound descriptions)

Summary of wound types

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Ethical Considerations

15 leg ulcers (of venous origin)

6 foot ulcers

7 5 of arterial origin

8 1 of neuropathic origin

9 11 of pressure soars

STANDARD DRESSING PROTOCOL
Confirm by wound swab cultures 10/5 - 10/6 organisms per ml, with clinical signs of infection Irrigate the wound with 3 % hydrogen-peroxide followed by through irrigation with normal saline.
Shallow wounds - up to 1 cm deep.
Select a size of Chemspunge® Wound Dressings that just covers the wound surface and apply directly onto the wound.
Bandage in position.
Photograph wound at commencement and every 6 days thereafter,  using a Kodak Iristatech x close-up camera.  At each dressing,  change records the following.
Date
Wound size
Amount of exudate (+, ++, +++)
Granulation tissue
Signs of epidermal regeneration
Wound Cavities - More than 1cm deep.
Pack the cavity with Chemspunge® plugs.
Cover with non-adherent secondary dressing - (Donor Aid)
Bandage in position.

Results
Chemspunge® Wound Dressings proved to easy to use and was readily accepted by the nursing staff,  possibly because in its dry form.
Chemspunge® Wound Dressings resembles a conventional non-woven dressing.
Chemspunge® Wound Dressings offers particular advantages in the treatment of deep wound cavity such as the sacral pressure sore.

CASE STUDY O22
Case Study 022, shows how effective Chemspunge® proved to be in promoting and maintaining the formation of granulation tissue,  and in maintaining control over wound exudate.
The wound base rapidly became covered with granulation tissue,  until,  by the 48th day of treatment,  the cavity was filled with granulation tissue,  wound contraction was evident,  and epidermal regeneration was apparent around the perimeter of the wound.  Because the amount of exudate was minimal Chemspunge® Wound Dressings were discontinued,  and treatment continued with Lyofoam,  until by the 56th day,  complete healing was achieved.

Using granules, beads,  powders,  or gels in the cavity in this case would have been extremely difficult.
Using Chemspunge® Wound Dressings,  however,  proved easy to remove and the dressing was easy to place into the cavity.
More over it stayed in position.

Average interval between dressing changes was 3 days.

Case Study 015,  was a lady aged 76 years,  who had suffered leg ulceration of venous origin for 14 years duration.
Epidermal regeneration occurred rapidly,  with 50 % healing being achieved in 28 days.
Patient was then transferred out of Darlington Health District.
A supply of Chemspunge® Wound Dressings,  and non-adherent secondary dressings,  and redressing instructions were supplied to the District Nurse.  Treatment with Chemspunge® Wound Dressings was discontinued after 50 days treatment,  because of a lack of wound exudate.
Treatment with Lyofoam continued,  until complete healing was achieved in 68 days.

Twenty-nine wounds out of the thirty-two wounds treated improved significantly,  of which 24 proceeded to complete healing,  and five continue treatment.
Three-foot ulcers of arterial origin did not respond,  due to worsening of their vascular impairment.

Overall, treatment with Chemspunge® Wound Dressings were applied over a mean period of 42 days,  Chemspunge® Wound Dressings being discontinued when the amount of exudate present was not adequate to permit ion exchange and gel formation.
The mean interval between dressings between changes of these,  at first heavily exuding wounds,  was 3.5 days,  compared to daily of twice daily changes when using conventional dressing.

Cost effectiveness
The patients suffering from leg ulceration had done so for periods ranging from 2 years to 31 years.
Over that period,  despite daily of twice-daily dressing changes,  very little healing was achieved at all.
Using conventional dressings,  the material costs involved to change the dressing on a daily basis was calculated to be ...1200 per ulcer per annum, or ... 3.28 per day.
Using Chemspunge® Wound Dressings,  the material costs involved at each dressing change are listed below:


Dressing pack
Chemspunge 7.5 x 12cm
Secondary dressing
Bandage
Normal saline 25 ml
Total
0.420
0.720
0.140
0.180
0.065
1.525
The mean period of treatment using Chemspunge® Wound Dressings was 43 days,  and the mean interval between dressing changes was 3.5 days,  or 12 dressing changes using Chemspunge® Wound Dressings.
Therefore, 12 x ... 1.525 = 18.30 total material costs using Chemspunge® Wound Dressings,  or 43.6 per day of treatment.
Compared to the use of conventional dressings,  therefore,  Chemspunge® Wound Dressings proved very cost-effective,  but in the process actually achieved significant amounts of healing.

Rate of healing
Using Chemspunge® Wound Dressings,  a mean rate of 1.7 % healing (of the initial wound area) of the surface area per day was achieved in the treatment of venous leg ulcers.
In the treatment of pressure sores,  granulation tissue formed at a rate of 2.1 mm / 3 per day.
No significant amount of healing occurred using conventional dressings for many years.
Clearly,  Chemspunge® Wound Dressings are an effective healing agent.

DISCUSSIONS
Conventional dressings,  such as gauze,  cotton wool,  and tulle grass,  are not capable of controlling wound exudate and allow leakage or strike-through in a matter of hours.
Consequently,  such dressings require changing at frequent intervals.
Furthermore,  conventional dressings allow cells to migrate through the weft and weave threads,  and become effectively glued to the wound surface,  or partially embedded in granulation tissue.
As the dressing is removed, islets of cells are quite literally torn away.
Any cellulose fibers remaining embedded in the tissues have been shown to act as foci for microorganisms and can contribute to granuloma formation.
Apart from stimulating a foreign-body reaction, the presence of such fibers can prolong the inflammatory phase of healing,  leading to chronic ulceration.
Clearly, conventional dressings have not contributed towards a rapid rate of healing.
In fact,  they may often delay the process.

Chemspunge® Wound Dressings,  however, absorbs excess exudate,  and in the process,  this is transformed into a hydrocolloid-type of gel over the wound surface.
As the dressing is removed,  the gel separates easily, eliminating trauma.
Thorough irrigation of the wound with saline solution effectively clears the remaining gel from wound cavities.
In any event,  the alginate gel can be further broken down into monosaccharides,  and are absorbed.

Because the alginate gel is semi-permeable,  and is hydrophilic in nature,  wound exudate is able to pass from the wound surface,  through the gel,  to be absorbed by an absorbent secondary dressing.
Furthermore,  water vapour can pass through the gel,  to be lost by evaporation.
However, unlike the cooling effect caused by evaporation from conventional dressing,  wound surface temperature under Chemspunge® Wound Dressings is not significantly changed.
Thus,  enzymatic and mitotic activities are maintained,  and cell migration can proceed without hindrance.

Expidermal cells require a moist surface across which they can migrate.
Drying of the wound surface forces the cells to burrow deeper until they meet a moist level,  delaying the healing process,  and contributing to scar formation.

Chemspunge® Wound Dressings maintains high humidity at the wound/dressing interface,  allowing uninterrupted migration of epidermal cells.
In fact, Chemspunge® Wound Dressings eliminates the need for the body to produce its own protective eschar,  speeding up the healing process,  and reducing scarring and contractives.

Many of the patients recruited to this trail were living at home in The Community,  attended by their District Nurse.
Chemspunge® Wound Dressings showed particular advantages in this situation,  since it was easy to use,  readily accepted by nursing staff,  and required a minimum amount of supervision.
Because of interval between dressing changes is extended to 3.5 to 4 days,  traveling costs must be reduced, and extra time saved for the nurse.
This can only contribute to higher standards of patient-care.
Finally, apart form its cost-effectiveness in use;  Chemspunge® Wound Dressings actually achieved very significant rates of healing,  greatly contributing to the job satisfaction of those involved with the trail.

COMPARATIVE TRAIL
The array of primary dressings now available for the treatment of open wounds,  i.e.  leg ulcers,  pressure sores, burns,  and skin-graft donor sites is now very large and continue to grow day by day.
Some confusion does exist amongst doctors and nurses regarding selection of the most appropriate dressing to be used on different types of wounds.
A number of Heath Authorities are now attempting to rationalize the range of dressing carried in stock.
Hitherto,  the unit cost of a dressing was the most important factor in any rationalization.
However,  pressure form Consumer Advisory Groups has caused H.S.'s to select dressings based on the results of comparative trails,  in which the operating characteristics of group of similar dressings are compared during use.

To date, comparative trails have been held for hydro gels,  hydrocolloids,  polyurethane foams,  and semi-permeable adhesive films.

Part B of this trail compared the in-use characteristics of Chemspunge® Wound Dressings (BritCair Ltd) and Sorbsan (Steriseal Ltd) and was carried out for the Northern Regional Consumer Advisory Group on Surgical Dressings.
The following information is a précis of the results of the trail.
A full report will be made available to both companies involved when it has been considered by the Consumer Group.

Whereas Chemspunge® Wound Dressings controlled wound exudate well,  in the presence of heavy exudation, Sorbsan quickly formed a gel,  and the matrix began to disintegrate after 1.5 days.
Consequently, Sorbsan required changing more frequently achieving a mean interval of 2 days between dressing changes.  Chemspunge® Wound Dressings achieved a mean interval of 3.5 days.
Significant differences in operating costs were observed.

Whereas Chemspunge® Wound Dressings achieved material costs of 43.6 p per day of treatment,  Sorbsan achieved material costs of 1.327 per day.  Overall, treatment continued for 42 days.
Over that period, Chemspunge® Wound Dressings achieved material costs of 18;  Sorbsan 56.  Clearly,  Chemspunge® Wound Dressings were the most cost-effective alginate dressing to use,  by a factor of 3.
This would be considerably greater,  of one considered transportation costs of the District Nurse.

During use,  if allowed to overlap onto skin surrounding the wound,  Sorbsan causes a build-up of partially - gelled fibers,  and proved difficult to remove, even when following the manufacturer instructions.
The latter included irrigation with normal saline,  but without effect.
It was necessary to peel off layers of altered fibers employing forceps,  in order to eliminate any potential pressure points.

Clearly,  it is important that a range of sizes of alginate dressings be available to allow selection of a size,  which covers the wound surface.
It is also important that wound surface temperature be maintained at 37c.
The alginate must,  therefore,  have the capability to control exudate.
In this respect,  Chemspunge® Wound Dressings controlled exudate better than Sorbsan.

To summarize:-
Chemspunge® Wound Dressings achieved a longer interval between dressing changes than Sorbsan.
Chemspunge® Wound Dressings proved to be 3 times cheaper to use than Sorbsan.

The soft white felt is a invert,  natural cotton fluff with adsorption properties and tested by Apptec U.S.  approved positive to allergies sensitivity.

Enveloped in a sleeve consist of 40 grm Polyester non woven material to keep the wound temperature normal and at the same time prevent exudate seep to the healthy skin areas.

A Johnson
District Infection Control Officer
Darlington Health Authority

Principal Investigator.
N.N.

Chemspunge® Wound Dressing.

Chemspunge® Wound Dressings are revolutionizing the Treatment of Wounds and Primary Burn Care world wide.

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