BANGALORE – KARNATAKA

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

THOMAS. C

1St year M.Sc (Nursing)

MASTER IN MEDICAL-SURGICAL NURSING

YEAR 2009-2010

CAUVERY COLLEGE OF NURSING

# 42/2B, 2C, TERESIAN CIRCLE

SIDDARTHA LAYOUT

MYSORE.

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGLORE

PROFORMA FOR REGISTRATION OF SUBJECT FOR

DISSERTATION.

01 /

NAME OF THE CANDIDATE AND ADDRESS

/ THOMAS.C
1st YEAR M.SC NURSING,
CAUVERY COLLEGE OF NURSING,
MYSORE.
02 /

NAME OF THE INSTITUTION

/ CAUVERY COLLEGE OF NURSING
03 /

COURSE OF THE STUDY AND SUBJECT

/

MASTER IN NURSING,

MEDICAL SURGICAL NURSING
04 /

DATE OF ADMISSION TO COURSE

/

15.06.2009

05 /

TITLE OF THE STUDY

/

AN EXPERIMENTAL STUDY TO EVALUATE THE EFFECTIVENESS OF LOCAL APPLICATION OF INSULIN ON PRESSURE ULCER AMONG THE BED RIDDEN PATIENTS

5.1 /

STATEMENT OF THE PROBLEM

/

AN EXPERIMENTAL STUDY TO EVALUATE THE EFFECTIVENESS OF LOCAL APPLICATION OF INSULIN ON PRESSURE ULCER AMONG THE BED RIDDEN PATIENTS IN SELECTED HOSPITALS OF MYSORE

6.1 INTRODUCTION:

The basic nursing care deals with many nursing procedures. Prevention and management of pressure sores very important one .Pressure sores affect people who are unable to change position regularly. Sustained pressure on those areas which support the body leads to reduced blood supply and eventually death of the skin and underlying muscles (a pressure sore).1 Pressure ulcers are typically located in areas such as heels, elbows, shoulders and the sacral region and are graded or staged to classify the degree of tissue damage.2

Bed sores more accurately called pressure sores or pressure ulcers, are areas of damaged skin and tissue, they develop when sustained pressure usually from a bed or wheel chair. 3 Pressure sores are caused by many factors such as unrelieved pressure, friction, humidity, shearing force, temperature, age, continence and mediation. Pressure sores occur on any parts of the body, especially portion over bony or cartilaginous area such as sacrum, elbows, knees, ankles etc.4

Risk factors of pressure sores are poor physical condition, poor mental condition, immobility, Being restricted to either sitting or lying down, incontinence, malnutrition, level of care needed. Complication of pressure sores are Maggot infestation, septicemia (blood inflammation of the bone), Abscess (collection of pus), Meningitis (infection and inflammation of membranes and fluid that surround the brain and spinal cord), Anaemia (deficiency of red blood cells).5

In the management of pressure ulcer the wound care is inevitable one. There are many antibiotic ointment used in the treatment of healing of pressure sores. The topical application of insulin in pressure sore promote the ulcer healing .It is used in animal studies in long back to find out the effectiveness of insulin on the ulcer healing. The evidence reported that topical application of insulin very effective in healing the chronic wounds. The insulin act and produce the proliferation and devitalisation of debilitated tissues leads to promotion of ulcer healing. 5

6.2 NEED FOR THE STUDY

The bed sore or decubitus ulcer is unresolved challenge in the nursing care of bed ridden patients. Especially the ulcer due to the chronic wounds leads to many complications. The topical application of insulin on pressure ulcer wounds found earlier but it is not supported with adequate studies in India.

In India February 2008 a study was conducted on about quality of life of people with spinal cord injury in India, Identify any association between clinical variable and quality of life, and finally to see the input of remedial measures taken to the quality of life over time. Thirty six (72%) men and 14 (28%) women participated. Mean age and duration of injury were 37.7 and 3.7 years respectively. Bladder problems (44%), bed sores(36%),gastrointestial problems(56%),naturopathic pain(42%)and spascity(60%)were the most common medical problem. There are 32% reported about the bed sores . 6

The topical application of insulin produces normal cell permeability, increase vacularizations, reduces exudations, arrest bacteria, enhance phagocytosis, stimulates proliferation and hypoxia of surrounding tissues.7

After the administration 100 small animals , the 30unit /Gm insulin applied for twice daily for two months in 50year old person with chronic debilitated wounds .Saran wrap covered all sides it helps to produce heat that force the insulin deep into the wounds. Transparent covering applied to observe the changes in healing process. Within 48 hours the inflammation reduced and within two weeks wound size reduced. The wound completely healed after two months.8

From the above supportive evidence the investigator plan to conduct the experimental study on effectiveness of topical application of insulin on pressure ulcer among bed ridden patients.

6.3 STATEMENT OF THE PROBLEM:

An experimental study to evaluate the effectiveness of local application of insulin on pressure ulcer among the bed ridden patients in selected hospital settings.

6.4 OBJECTIVES

  1. To assess the pre test level of ulcer healing in both experimental and control group.
  2. To evaluate the effectiveness of local application of insulin on pressure ulcer in both experimental and control group.
  3. To associate the post test level of ulcer healing with selected socio demographic variable in both experimental and control group such as age, sex, duration of illness, type of illness, body built, etc.

6.5 HYPOTHESES

H1. There will be significant increase in the level of ulcer healing in experimental group than in control group.

H2. There will be significant association between experimental group and control group with there demographic variables such as age, sex, duration of illness, type of illness, body built, etc.

6.6 OPERATIONAL DEFINITIONS

1. EVALUTE: Measure the level of healing of pressure ulcer before and after the intervention.

2. EFFECTIVENESS: Outcome of the intervention (local application of insulin) measured in terms of stages of wound healing.

3. LOCAL APPLICATION OF INSULIN

Topical application of Insulin 15 IU of plain insulin applied on the pressure ulcer or pressure sore.

4. PRESSURE ULCER.

It is a sore that, people who are unable to change position regularly, or prolonged bed ridden. Sustained pressure on those areas which support the body leads to reduced blood supply and eventually death of the skin and underlying muscles.

5. BED RIDDEN:

The patient those who are unable to move from the bed for a long time.

6.7 ASSUMPTION:

1. Insulin application effective in chronic wounds.

2. Insulinase enzyme present in insulin prevents the decay of debilitated tissue.

3. Insulin application produces revascularization in gangrene tissues.

6.8 DELIMITATION:

1. The sample size is limited to 60 patients.

2. Prescribed data collection period is only 4 to 6 wks.

6.9 CONCEPTUAL FRAME WORK:

Open system model.

6.10 REVIEW OF LITERATURE:

The review of literature is defined as abroad, comprehensive in depth, systematic and critical review of scholarly publications, unpublished scholarly print materials, audio visual materials and personal communications.

The review of literature will be discussed based on the following headings.

Studies related to the incidence and prevalence of pressure sores in bedridden patients

In 2005 the conducted study on the national pressure ulcer long term care study on to identify resident, wound and treatment characteristics associated with pressure healing in long term residents. This study consist of 882 residents aged 18 and above , length of stay of 14 days or longer , who had at least one stage II- IV pressure ulcers. Data collected about resident characteristic, treatment characteristic and change in pressure area. The area of second stage pressure ulcers was reduced more with moist than with dry dressing , cleaned with saline or soap showed less decreased in area then cleaned with antiseptic with antibiotic. Change in position and sufficient enternal feeding was done in stage III and IV . This study concluded that use of moist dressing (stage II, III, and IV) and adequate nutritional support (stage III and IV ) increased pressure ulcers healing.9

In 2008,a study was conducted by, about a national prevalence study of pressure ulcers in French hospital in- patients. A total of 37,307 inpatients in 1170 wards in 1149 hospitals were assessed. In all 3314 patients had at least one pressure ulcer, giving a prevalence rate of 8.9% A total of 4991 pressure ulcers were recorded 64% of the patients had only one pressure ulcer. The most common locations were the heel (53%) and sacrum (29%) These results indicates that the prevalence of pressure ulcers in French hospital inpatients has remained stable since last 10 years, such studies should be encouraged in all health care settings. 10

In 2008 ,a study was conducted regarding the quality improvement program to reduce the prevalence of pressure sores in an intensive care unit, America. In which 563 survey of patients skin were preformed during 22 audits conducted during a 26- month period .one –on –one clinical instruction was provided to bed side nurses during the survey, and pressure ulcer data were displayed in the clinical area. The prevalence of pressure sore were decreased from 50% to 8% The appropriate allocation of pressure- relieving devices increased from 75% up to 95% to 100%. This program was s in reducing the prevalence of pressure ulcers among vulnerable intensive care patients and indicates that quality improvement is a highly effective formula for improving patient outcomes. 11

A study was conducted on 2005, about the prevalence of pressure ulcers in hospital in India. A total of 445 patients hospitalized in medical and surgical wards were examined in a single day for the number, site and grade of pressure ulcers. prevalence of pressure ulcers were high(4.94%).Anaemia,mal nutrition, and diabetes were important risk factors. In India identifying their associated risk factors at an early stage may go a long way in preventing their occurrence. 12

A study was conducted by regarding innovative, effective, negative pressure device for management of pressure sores in traumatic paraplegia has been a challenge since in immemorial conventional serial debridement and dressing require prolong hospitalisation, imply possible complications and are an economic burden. Negative Pressure Device (NPD) converts open wound into close controlled wound, by drawing away fluids from the wound, it prevented collection of secretion and decreased prutulence.NPD is abed side procedure easy to apply with minimal side effects. the NPD apparatus suggested is innovative, cost effective. 13

Studies related topical application of insulin and ulcer healing

In New York, 2007 the study applied daily, uniocular porcine insulin drops (0.75%) to diabetic rats for 14 months and then analyzed their retinas for vascular pathology. Results shows that high-dose insulin eye drop treatment increased the number of retinal cellular capillaries, with many of these capillaries exhibiting a degenerated, threadlike appearance. The retinas also showed extensive capillary obliteration and had tangled masses of vascular cells. The glycated hemoglobin levels of eye drop-treated rats were similar to those found in control, vehicle-treated diabetic animals at sacrifice. Retinal insulin levels remained elevated after a 2-week regimen of daily insulin eye drops, suggesting that our treatment protocol resulted in the pooling of insulin in the retina. A similar treatment regimen was also found to have no effect on retinal glucose concentration. The results indicated that treatment of diabetic rats with daily, high-dose insulin eye drops intensified their retinal pathology.14

In Germany the study investigated cell proliferation and local insulin-like growth factor-I (IGF-I) expression in ischemic wounds after topical application of IGF-I through different delivery systems. IGF-I dressings were fabricated from an IGF-I containing polyvinyl alcohol film placed on a standard hydrogel dressing. In vitro, the release of IGF-I from this dressing was assessed by enzyme-linked immunosorbent assay. For animal experiments, a standardized ischemic skin flap containing a full-thickness wound was created on the back of male Sprague-Dawley rats. An identical wound outside the flap served as control. The study initially investigated intracutaneous pO2 (p(ti)O2), cell proliferation, and local IGF-I expression. In a second setting, wounds were treated either with IGF-I dissolved in methylcellulose gel or with an IGF-I dressing, and ulcer size and cell proliferation were assessed. In vitro, approximately 60% of IGF-I was released from the IGF-I dressing, compared to a 97% release from methylcellulose gel. In vivo, ischemic wounds showed less cell proliferation and decreased IGF-I expression than nonischemic wounds. A lower local p(ti)O2 correlated with larger wound size, less cell proliferation, and decreased IGF-I expression. Ulcer size was reduced after treatment with either IGF-I dressing or methylcellulose gel. However, cell proliferation only increased after treatment with IGF-I dressing, but not after methylcellulose gel treatment. We conclude that IGF-I expression is decreased in ischemic wounds and correlates with low cell proliferation. This can be reversed by local IGF-I application, but the efficacy of treatment depends on the delivery system.15

In USA the study conducted on wounds become chronic, individuals are susceptible to generalized inflammatory cascades that can affect many organs and even lead to death. Skin is the most commonly injured tissue, and its proper repair is important for reestablishment of its barrier function. Results show here that insulin, when topically applied to skin excision wounds, accelerates re-epithelialization and stimulates "maturation" of the healing tissue. These effects are dependent on the insulin receptor but independent of EGF/EGF-R; PI3K-Akt-Rac1 signaling pathways are critically involved, and healing is α3 and LN332-dependent.The study concluded that insulin has great potential for the treatments of chronic wounds in which re-epithelialization is impaired.16

In 2009 in Tureky,the study conducted to determine the effects of topical insulin administration on wound healing in rats with or without acute diabetes. Methods. This study was conducted using four groups of male Sprague-Dawley rats: (i) nondiabetic rats receiving topical insulin (n = 7), (ii) nondiabetic rats receiving topical sterile water (n = 7), (iii) diabetic rats receiving topical insulin (n = 7) and (iv) diabetic rats receiving topical sterile water (n = 7). Wound healing was assessed by wound contraction rate, complete epithelialization time and histological results. Results. Topical insulin enhanced wound healing by shortening the time needed for complete epithelialization in both the nondiabetic and acute diabetic groups. The histological observations supported the planimetric results in both groups. Conclusions. This study revealed that topical insulin application to cutaneous wounds accelerates wound healing in rats with or without acute diabetes.17