Rajiv Gandhi University of Health Sciences, Karnataka

SYNOPSIS

FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. NAME OF THE CANDIDATE Mrs. Ansu mariam john

2. NAME OF THE INSTITUTION Manasa college of nursing mallur.

3. COURSE OF STUDY AND SUBJECT Master Of Science In Nursing

Medical &Surgical Nursing

4. DATE OF ADMISSION TO COURSE

5. TITLE OF THE TOPIC

“EFFECTIVENESS OF NEGATIVE

PRESSURE WOUND THERAPY ON

DIABETIC WOUND AMONG DIABETIC

PATIENTS IN SELECTED DIABETIC

CLINIC IN BANGALORE, KARNATAKA.”

6. BRIEF RESUME OF THE INTENDED WORK

INTRODUCTION

Human diseases occur mostly due to the result of heredity, environment or food. It is not

possible to change heredity, it is difficult to change environment, but it is relatively easy to

control.

Metabolic disorder is a global health problem, in this diabetes mellitus is an ‘iceberg’ disease

posing a serious threat to be met within the 21st century. Diabetes mellitus is epidemic in both

developed and developing countries2.

India is considered as the capital of the world of diabetics. This is because one fifth of the

world's diabetic population (285 million) are Indians. At the recently concluded IDF

conference, it was mentioned that India has about 58 million diabetics and China lags behind

at 43 million! These numbers are expected to increase another 50 per cent in next 20 years or

so. For every diabetic patient that is diagnosed in a population, there is one undiagnosed

patient.

The symptoms of diabetes were described on an Egyptian papyrus, the Ebers papyrus, which

dates to about 1500 BC. In the first century, the Greek physician Areatus wrote a malady in

which the body “ate its own flesh” and gave off large quantities of urine. He named it diabetes,

the Greek word meaning “siphon” or “to pass through”. In the seventeenth century, the word

mellitus, from the Latin word meaning “honey” was added because of the sweet nature of the

urine. Today, the simple term diabetes refers to diabetes mellitus3.

Around 150 million people suffer from diabetes in the world. With the increasing incidence of

diabetes, India leads the world today with the largest number of diabetics in any given country

followed by China and USA. Every fifth diabetic patient in the world is in India and every

fifth adult in Indian urban area is a diabetic4

Presenting symptoms of diabetes mellitus are varied. However, an important fact is often

overlooked that that nearly 50 per cent patients are asymptomatic. Awareness about this disease

(and the complications that can develop) will prompt patients and the public at high risk to go

for a regular follow up.

Diabetic complications generally develop after 12-15 years of diabetes. Around 15-25 per cent

patients are unfortunate enough to have varying degree of complications at the time of

diagnosis. This is explained by the fact that when the diagnosis of diabetes is made, the patient

has already had some degree of glucose intolerance (undiagnosed) for an average of six to eight

years. These complications lead to organ dysfunction and damage. The damage could be in

sight/limb/any organ or even be life threatening!!

Complications

The chronic complications are divided into two categories

a) Those which are typical to diabetics (microvascular complications) and include retinopathy,

nephropathy, neuropathy and vasculopathy.

b) Those which could occur in the general population too (macrovascular complication) and

includes atherosclerosis, acute myocardial infarction or stroke. These complications do occur

more frequently in the diabetics as compared to non-diabetics.

Retinopathy

Most patients are asymptomatic at the onset of this complication, just because the patient does

not complain does not mean that everything is fine. There is a need for examination by an

ophthalmologist for early diagnosis of eye involvement in diabetes. Visual complaints would

indicate that already eye complications have reached an advanced stage!

Nephropathy

Patients have no physical complaints or biochemical changes till 50 per cent damage to the

kidneys has occurred. Hence there is a need for regular check up and investigations. A simple

urine test (microalbuminuria) could point to the onset of nephropathy.

Neuropathy

This is possibly the commonest of chronic complications. It presents with

Tingling, numbness, burning sensation (specially feet at night).

Constipation, diarrhea, alternating constipation and diarrhea.

Bloating sensation.

Postural giddiness.

Sexual disturbances.

Unexplained episodic sweating.

Vasculopathy

It is the involvement of small arteries especially of the feet. It is probably the most easily

preventable and at the same time the most overlooked complication.

Foot problems could include:

Delayed wound healing.

Extensive infection.

Gangrene.

Susceptibility to infection decreased blood flow, diminished vision and reduced sensations all

contribute in varying degree to the high frequency and poor outcome of foot problems.

Neglect of the feet could lead to problems which may culminate in amputation of toe/ foot/ leg.

If one were to see a person with a non-traumatic amputation of toe/ foot, then it would be safe to

guess that he is either a diabetic or/and a smoker.

People with diabetes develop foot ulcers because of neuropathy (sensory, motor, and autonomic

deficits), ischaemia, or both. The initiating injury may be from acute mechanical or thermal

trauma or from repetitively or continuously applied mechanical stress. Patients with clinically

significant limb ischaemia should be assessed by a vascular surgeon to determine the need for

angioplasty, stenting, or femoro distal bypass. When infection complicates a foot ulcer, the

combination can be limb or life-threatening. Infection is defined clinically, but wound cultures

reveal the causative pathogens. Tissue specimens are strongly preferred to wound swabs for

wound cultures. Antimicrobial therapy should be guided by culture results, and should aim to

cure the infection, not to heal the wound. Alleviation of the mechanical load on ulcers (off-

loading) should always be a part of treatment. Neuropathic ulcers typically heal in 6 weeks with

total contact casting, because it effectively relieves pressure at the ulcer site and enforces patient

compliance. The effectiveness of pressure relief is already proved through studies.

6.1NEED FOR THE STUDY

Diabetes mellitus is a group of metabolic diseases characterized by increased levels of

glucose in the blood, resulting from defects in insulin secretion, insulin action or both. The

major classifications of diabetes are type I diabetes, type II diabetes, gestational diabetes and

diabetes mellitus associated with other condition or syndromes. Diabetes is the third leading

cause of death from disease, primarily because of the high rate of cardiovascular disease such

as myocardial infarction, stroke, and peripheral vascular disease. Clinical manifestations of

all types of diabetes include the ‘three Ps’, polyuria, polydipsia and polyphagia8.

The World Health Organization estimated that the global number of people with diabetes is

expected to be at least 220 million in 20105. WHO and the International Diabetes Federation

predict that the number of diabetics in Asia could increase to 160 million by the year 20255.

It was projected that by the year 2025, 250 million people world over will be affected, of

these 75% will be from developing countries. But in the year 2008, it is projected that 300

million people with diabetes is expected by the year 20258.

According to the IDF’s 2003 statistics, the top 5 countries with the largest number of

diabetics were: India - 35.5 million, China - 23.8 million, USA - 16.0 million, Russia - 9.7

million and Japan - 6.7 million9

Diabetes mellitus is a deadly disease in India. In 1995, 19.4 million individuals were

affected; it is likely to go up to 57.2 million by the year 203010. The committee of RSSDI

2009 spoke about the dismal statistics of diabetes in India. Apparently, India which has the

highest numbers of diabetics in the world will home to about 51 million diabetics by 2010

and slated to touch 80 million by 203010.

There is now sufficient evidence to show that negative pressure wound therapy is safe, and

will accelerate healing, to justify its use in the treatment of diabetes-associated chronic leg

wounds. There is also evidence, though of poor quality, to suggest that healing of other

wounds may also be accelerated. VAC therapy was useful in the treatment of diabetic foot

infection and ulcers, which after debridement, may present with exposed tendon, fascia

and/or bone. These included ray amputation wounds, wounds post-debridement for

necrotising fasciitis, wounds post-drainage for abscess, a heel ulcer and a sole ulcer. It was

able to prepare ulcers well for closure via split-skin grafting or secondary closure in good

time. This reduced cost of VAC therapy,as therapy was not prolonged to attain greater

reduction in wound area.VAC therapy also provides a sterile, more controlled resting

environment to large, exudating wound surfaces. Large diabetic foot ulcers were thus made

more manageable.

6.2 REVIEW OF LITERATURE

A review of literature refers to activities involved in identifying and searching for information

on a topic and developing and understanding the state of knowledge on the topic. Researcher

never conduct a study in an intellectual vacuum their studies are usually undertaken within the

context of an existing basic knowledge

The literature is reviewed and presented under the following headings

1. Literatures related to Complications of diabetic

2. Literatures related to effect of negative pressure on diabetic wound

Literatures related to Complications of diabetic

Diabetes mellitus is a chronic systemic disease characterized by either a deficiency of insulin or

a decreased ability of the body to use insulin. Diabetes mellitus some time referred to as “high

sugars” by both client and health care providers. Diabetes was classified as either Type 1

diabetes mellitus or Type 2 diabetes mellitus23.

Diabetes Mellitus is caused by genetic defects, disease of the pancreas,

endocarcinopathies, drugs or chemical and infections. Management of diabetes mellitus

includes; regulate blood glucose, promote proper nutrition, promote regular physical exercise,

and administer medications such as oral antidiabetic agents and insulin therapy23.

A study was conducted to assess the knowledge and practice of diabetes mellitus

patients. The study revealed certain facts about the knowledge and practice of diabetes mellitus

patients with relation to prevention of selected diabetic complications such as hyperglycemia,

hypoglycemia and wound infections etc. The resulted revealed that 60% had inadequate

knowledge, 32.4% had moderately adequate knowledge and 21% had adequate knowledge24.

A community based study was conducted to assess the knowledge of 57 elderly diabetes

mellitus patients. Data was collected by the interview and the result showed that 18% did not

know what action to take with hyperglycemia, 46% did not know any hyperglycemic symptoms

or signs, 35% did not know what to do when self monitored blood sugar tests and urine sugar

tests read high, 21% did not seek medical advice on insulin25.

A study was conducted to assess the knowledge of diabetes mellitus patients by using

computer - based questionnaire. A sample of 79 Type 1 diabetes mellitus and 72 Type 2

diabetes mellitus patients were taken for the study. Their result showed that ignorance in key

areas like causes of hyperglycemia, undesirable effect of sugar and sweet foods, symptoms of

hyperglycemia, diet, foot care and therapy were unacceptably high in both type 1 diabetes

mellitus and type 2 diabetes mellitus groups26.

A comparative study was conducted to assess the knowledge of diabetes mellitus

possessed by patients with diabetes and healthy adult. They randomly selected 120 patients with

diabetes mellitus and 120 healthy adults for the study. Their result showed that patients with

diabetes mellitus were significantly more knowledgeable than the healthy volunteers about risk

factors, symptoms, chronic complication, treatment, self-management and monitoring

parameters. Educational level was the best predictive factor for diabetes mellitus and public

awareness28.

In a study the level of knowledge of diabetic patients about the disease was described. It

was found that a majority of diabetic patients [90.0%] had poor knowledge about the disease,

83.7% had poor knowledge about the complications associated with diabetes and 96.3% had

poor awareness of how to control the disease29.

A study was conducted to know, if weight loss has an effect on how beta cells work and

the effectiveness of beta cells in slowing the progression of diabetes in older patients as

improving insulin sensitivity does. 19 overweight and obese older men with normal fasting

blood glucose were studied for 3 months and the men were weighed three times per week.

The result showed that the men in the study lost an average of nine pounds. All the men lost

weight, with fat making up 84% of the weight loss. Fasting blood glucose levels were lower

after the weight loss. Insulin sensitivity improved, resulting in an improvement in beta cell

function31

Literatures related to effect of negative pressure on diabetic wound

In a study Pseudomonasaeruginosa bio film model was developed to mimic potential surface

wound biofilms. Topical negative pressure dressing was applied to the model and the effects of

topical negative pressure dressing on the in vitro wound biofilms were examined using both

quantitative microbiological counting technique and imaging studies. The results demonstrated

a small but statistically significant reduction in biofilm bacteria at 2 weeks when exposed to

topical negative pressure. When this was combined with silver impregnated foam, the reduction

was far more significant and was observable within 24 hours. Microscopically, it was also noted

that topical negative pressure compressed the biofilm architecture with a reduction in thickness

and diffusion distance.

Negative-pressure wound therapy (NPWT) has been used to help wound healing since early

1970s, and it has been used increasingly for treating a wide variety of wounds since the

early1990s and started to popularize in China near the mid 1990s. This technique is different

from conventional dressing change, as it controls local humidity, alleviates edema, and

improves local circulation all by negative pressure. The method generally involves the

application of a dressing on the wound surface, connecting the dressing to a vacuum pump

through a tube, and then sealing the wound with adhesive films. Most of the clinicians in China

believe that NPWT is helpful in accelerating wound healing.

Diabetic lower extremity wounds cause substantial burden to healthcare systems, costing tens of

thousands of dollar. Negative pressure wound therapy (NPWT) devices have been shown to be

cost-effective at treating these wounds, but the traditional devices use bulky electrical pumps

that require a durable medical equipment rental-based procurement process. The Spiracur

SNaP™ Wound CareSystem is an ultraportable NPWT system that does not use an electric

pump and is fully disposable. It has superior healing compared to standard of care with modern

dressings and comparable healing to traditional NPWT devices while giving patients greater

mobility and giving clinicians a simpler procurement process. shows that the SNaP™ system

could save substantial treatment costsin addition to allowing patients greater freedom and

mobility.

In another study done locally to determine the effectiveness of vacuum-assisted closure (VAC)

therapy in the healing of chronic diabetic foot ulcers.An electronic vacuum pump was used to

apply controlled negative pressure evenly across the wound surface. Changes in wound

dimension, presence of wound granulation and infection status of diabetic foot ulcers in 11

consecutive patients with diabetes were followed over the course of VAC therapy, Healing was

achieved in all wounds.Nine wounds were closed by split-skin grafting and2 by secondary

closure. The average length of treatment with VAC therapywas23.3 days. Ten wounds showed

reduction in wound size. All wounds were satisfactorily granulated and cleared of bacterial

infection at the end of VAC therapy.

A systematic literature search for relevant RCTs was carriedout. The credibility of the outcome

of each study was evaluated using aspecially constructed instrument. researchers identified 17

RCTs, of which five had not been included in previous reviews or health technology

assessments. For diabetic foot ulcers (seven RCTs), there was consistent evidence of the benefit

of NPWT compared with control treatments. For pressure ulcers (three RCTs), results were

conflicting. In trials involving mixed wounds (five RCTs), evidence was encouraging.

Statement of the problem

A study to assess the effectiveness of negative pressure wound therapy on diabetic wound

among diabetic patients in selected diabetic clinics in Bangalore,.”

6.3. Objectives of the study

1. To assess the pre interventional level of diabetic wound in experimental and control group.

2. To assess the post interventional level of diabetic wound in experimental and control group.

3. To compare pre and post interventional level of diabetic wound in experimental group

4. To compare the pre post interventional level of diabetic wound in control group.

5. To compare the pre interventional level of diabetic wound between experimental and control

group.

6. To compare the post interventional level of diabetic wound between experimental and

control group.

7. To associate the mean improvement level of diabetic wound with selected demographic

variable in experimental and control group.

Operational definitions

EFFECTIVENESS: It refers to the outcome of negative pressure administration with regard to

reduction in wound size.

NEGATIVE PREEURE WOUND THERAPY: is a therapeutic technique using a vacuum

dressing to promote healing in acute or chronic wounds and enhance healing of first and second

degree burns.

DIABETIC CLIENTS

Patients who are diagnosed as type 2 diabetics by a qualified physician, having fasting blood

glucose level of more than 110mg/dl.

Hypothesis

H1: There will be a significant difference between pre and post interventional level of

diabetic wound in experimental group

H2: There will be a significant difference in the post interventional level of diabetic wound

between experimental and control group.

H3: There will be a significant association of the mean improvement level of diabetic wound

with selected demographic variables in experimental and conrol group.

Assumptions

1. The diabetic patients may have delayed wound healing.

2. NPWT may have an effect on diabetic wound.

Delimitations

Study is limited to

1. Diabetic clients with diabetic ulcers attending selected diabetic clinic in Bangalore Only

MATERIALS AND METHODS:

7.1: SOURCES OF DATA: Diabetic clients in selected diabetic clinic.

7.1.1 RESEARCH DESIGN AND APPROACH: The research design which will be adopted

for this study is Quasi experimental design with control group and approach used will be

quantitative approach.

7.1.2 SETTING: Study will be conducted in selected diabetic clinic in Bangalore.

7.1.3 POPULATION: The population of the present study will be all diabetic clients attending

diabetic clinic.

7.1.4 SAMPLES: it includes diabetic clients fulfilling inclusive criteria

7.1.4 VARIABLES:

Dependent variable: diabetic wound

Independent variable: negative pressure wound therapy

Demographic variables: Age, sex, education, occupation, income, history of diabetes mellitus,

dietary pattern.

7.2: METHODS OF DATA COLLECTION

7.2.1 SAMPLING TECHNIQUE: Non random Purposive sampling technique will be used

to select the samples for the study.

7.2.2 SAMPLE SIZE:60 experimental group 30 control group 30

7.2.3 INCLUSION CRITERIA: Diabetic patients those who are

Available during the time of data collection.

Willing to participate in the study.

Having diabetic wound.

Both males and females.

7.2.4 EXCLUSION CRITERIA: Diabetic patients those who are

Diagnosed to have major health problems associated with diabetic

Taking prescription medication that could interfere with wound healing.

7.2.5 DATA COLLECTION TOOL:

SECTION A: Structured questionnaire to assess demographic data of diabetic patients.

SECTION B: scale to assess the diabetic wound and structured observational check list

7.2.6 METHOD OF DATA COLLECTION: Prior to data collection permission will be

obtained from concerned authority. Consent will be obtained from the diabetic patients prior to

the conduction of the study. Data will be collected by the investigator herself by using

structured questionnaire & biophysiolocal assessments before intervention i.e. administration of

negative pressure for a period of 7 days. After 7 days investigator herself will collect data to

find out the effectiveness.

7.2.7 METHOD OF DATA ANALYSIS: The collected data will be organized by

1. Descriptive statistics:

Frequency distribution,

percentage, mean,

standard deviation will be used to assess the demographic variables and the pre-test and

post-test scores.

2. Inferential statistics:

Paired t-test will be used to compare the pre-test and post- scores

Chi-square test will be used to determine the association of post-test scores with the

selected demographic variables.

Analyzed data will be presented in the form of tables, diagrams, graphs based on the findings

7.3: DOES THE STUDY REQUIRED ANY INVESTIGATIONS OR INTERVENTION

TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS? IF SO,

PLEASE DESCRIBE BRIEFLY.

Yes, effectiveness of negative pressure wound therapy on diabetic wound among diabetic

patients in selected diabetic clinics in Bangalore,.”

7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTE IN

CASE OF 7.3?

Yes, informed consent will be obtained from concerned authority of institution and subject prior

to study, Privacy, confidentiality and anonymity will be guarded. Scientific objectivity of the

study will be maintained with honesty and impartiality

REFERENCES

1.  Lillis, Karin (2003). "Effective wound care requires look at total patient picture". Healthcare Purchasing News 27 (1): 32. ISSN 0279-4799

2. Moody, Yasmeen (19 July 2001). "Advances in healing chronic wounds". The Ithaca Journal(Ithaca, NY): p. 10

3.  Fogg, Erich (27 August 2009). "Best treatment of nonhealing and problematic wounds".Journal of the American Academy of Physician Assistants 22 (8): 46, 48

4. Driscoll, P (24 October 2009). "Negative Pressure Wound Therapy (Gauze and Foam)".Advanced Medical Technologies.

5. Gupta, Subhas; Bates-Jensen, Barbara; Gabriel, Allen; Holloway, Allen; Niezgoda, Jeffrey; Weir, Dot (2007). "Differentiating Negative Pressure Wound Therapy Devices: An Illustrative Case Series". Wounds 19 (1 (Supplement)): 1–9. Retrieved 11 January 2011.

6.  Xie, X.; McGregor, M.; Dendukuri, N. (November 2010). "The clinical effectiveness of negative pressure wound therapy: a systematic review". Journal of Wound Care 19 (11): 490–5.PMID 21135797.

7. Ubbink, Dirk T; Westerbos, Stijn Joël; Evans, Debra; Land, Lucy; Vermeulen, Hester (2008). Ubbink, Dirk T. ed. "Topical negative pressure for treating chronic wounds". Cochrane Database of Systematic Reviews 16 (3):

8. ^ Gerry R, Kwei S, Bayer L, Breuing KH (2007 Jul). "Silver-impregnated vacuum-assisted closure in the treatment of recalcitrant venous stasis ulcers". Ann Plast Surg. 59 (1): 58–62.

9.  Wendling, Patrice (April 2008). "Vacuum-assisted wound therapy uses expanded". Skin & Allergy News

10. Moch D, Fleischmann W, Westhauser A (1998). "Instillationsvakuumversiegelung: ein erster Erfahrungsbericht [Instillation vacuum sealing—report of initial experiences]" (in German).Langenbecks Archiv für Chirurgie 115: 1197–9. 

11."Vacuum Assisted Closure Wound Therapy Cleared for Partial Thickness Burns". Reuters Health Medical News. January 27, 2003.

12. Baxter, Helena; Ballard, Kate (2001). "Vacuum-Assisted Closure". Nursing Times 97(35): 51–2. 

13.Miller, Michael S.; Brown, Rhonda; McDaniel, Cheryl (1 September 2005). "Negative pressure wound therapy options promote patient care". Biomechanics: p. 49.

14. Glat, Paul (8 July 2010). "The use of negative pressure wound therapy with Bio-Dome™ dressing technology". Today's Wound Clinic. Retrieved 20 January 2011

15. Michael S., Miller (February 2009). "Multiple approaches offer negative pressure options".Biomechanics.

16. Morykwas, Michael J.; Argenta, Louis C.; Shelton-Brown, Erica I.; McGuirt, Wyman (1997). "Vacuum-assisted closure: a new method for wound control and treatment". Annals of Plastic Surgery 38 (6): 553–62. 

17.Long, Mary Arnold; Blevins, Anne (2009). "Options in negative pressure wound therapy". Journal of Wound, Ostomy and Continence Nursing 36 (2): 202–1