Complications Of Skeletal Traction Health And Social Care Essay

In the last two decades, there have been major changes in the management of lower limb long bone fractures, surgical management has become the norm. Skeletal traction is now rarely used as the definitive form of management.

Most of the patients admitted to our hospitals have skeletal injuries, and these patients have prolonged length of stay as they are initially managed non- operatively.

Complications of traction have been looked at since 1947 and have been published but literature from the developing countries is lacking. This study is being conducted to evaluate the prevalence of complications associated with skeletal traction with lower extremity fractures.

Objective : –

To determine the proportion of patients with Lower Extremity fractures who develop complications associated with skeletal traction.

Study Design:-

This is a Hospital based Prospective Descriptive study, that will be carried out from December 2010 to March 2011.

Study Setting :-

The study will be carried out at the KNH orthopaedic wards.

Materials and Methods :-

Patients who are put on lower limb skeletal traction will be recruited into the study, They will be reviewed weekly for complications namely pin tract infection, pressure sores, venous thrombo-embolism, orthostatic pneumonia and knee stiffness, until upto the point they are taken off traction. The data will be collected using pre-designed questionnaires.

INTRODUCTION

Fractures of the femur are almost always the result of great violence and are sometime a threat to the patients life, not only because of the immediate complications such as bleeding or associated injuries but also because of subsequent complications related either to the treatment of the fracture or to the complications of the associated injuries.

Immobilization of the fracture was recognised as essential for union. The development of splints, such as the Thomas splint and the subsequent combinations of the splints with traction methods either fixed or balanced, allowed for better control of the fracture, patients never the less had to remain in traction for three months or longer before the fracture was sufficiently stable to allow ambulation.

Skeletal traction is seldom used in modern practice, usually it is only a temporary mode of treatment. Internal Fixation is still the treatment of choice for most closed injuries, this is because of higher union rates, lower rates of complications, earlier weight bearing, shorter hospital stays and early return to daily activites.

In KNH majority of the patients admitted with femoral fractures are managed initially on skeletal traction. Patients with proximal femoral fractures are on Russel Hamilton’s traction while patients with femoral shaft fractures are on Perkins traction.

When the patient is managed on skeletal traction the patient is on prolonged bed rest and hospital stay increases also nursing care is difficult and the patient is at risk of developing morbidities due to the skeletal traction and prolonged immobilisation. The cost of care is increased and as seen in our setting most of the patients we manage come from a low socio-economic background who have difficulties in financing their healthcare.

The prolonged confinements of the patients on traction is associated with certain complications, such as pin tract infections, decubitus ulcers, which can be overcome by better nursing care, but the complications of prolonged bed rest such as bladder and bowel derangements, deep venous thrombosis, osteoporosis, muscle wasting, to mention only a few cannot be prevented hence the need for early internal fixation.

Literature Review

Motor vehicle crashes are the leading cause of death in adolescents and young adults (1,2,3,4) and of the estimated 856 000 road deaths occurring annually worldwide, 74% are in developing countries (5).

In both Nigeria (6,7) and Kenya (8), for example, a fivefold increase in traffic-related fatalities was observed over the last 30 years.

Injuries cause profound morbidity and are one of top 10 causes of death and disability in both developing and developed economies (9).

Kenya, like other developing countries, lacks organised efforts to reduce the burden of injuries. Although there is debate as to whether trauma systems in high-income countries are transferable to developing economies, baseline studies providing accounts of injury and injury trends in least developed countries are scanty.(10)

Media reports have raised concern over rising road accident injuries in Kenya. Most of these occur in the capital city, Nairobi (11).

Those injured mainly receive treatment at the Kenyatta National Hospital (KNH) the city’s main hospital. The city lacks a systematic pre-hospital care and the patients arrive at the institution at any time and unannounced.

As demonstrated in Saidi’s study, the injured are transported to hospital by private vehicles in the majority of cases. Ninety two per cent of the casualties arrive at KNH without any pre-hospital optimisation. (10)

Saidi et al (12)found 31.0% of all admissions at KNH are due to injury indicating that a large volume of trauma admissions is handled at this public hospital.

The average length of hospital stay of 14 days is from Saidi’s study is much longer than in reports from established trauma facilities. At the Vancouver General and Teaching Hospital, Canada, the length in 1997 was 9.14 days despite caring for patients with severer injuries (24% with ISS > 16) than in Saidi’s (12) cohort of patients (13.4% with ISS > 15) [12,13].

The excess length of hospital stay at KNH is caused by the predominance of skeletal injuries. Long bone fracture fixation is usually performed late, a practice occasioned by the local economic environment and a limiting factor for external validity of this outcome measure. An initial period of nonoperative care, which may last up to 4 weeks, is inevitable. The delay is caused by time spent to raise funds for desired implants.

Many patients (90%) pay for the services out of their pockets [14]. If a policy of early fracture treatment incorporating a care reimbursement system that does not delay the operative intervention is introduced, the average length of stay may improve. This early fixation would additionally prevent pulmonary failure state, alleviate pain, ease nursing care, reduce complications [15], and allow early rehabilitation and return to work.

The principles of traction are a pulling force that is applied to part of the body i.e. the limbs, the pelvis or spine and another force applied in the opposite direction called counter traction. The forces involved in traction are based on Newton’s third law of motion, which states for every action there has to be an equal and opposite reaction.

Malgaigne characterized as the greatest surgical historian, and author of the 1st comprehensive work on the diagnosis and the treatment of fractures (18), credits Guy de Chauliac with the introduction of continuous, isotonic traction in the treatment of fractures of the femur. This was accomplished by suspending a weight, attached to the leg by a cord over a pulley at the foot of the bed.

The use of traction dates as far back as 3000 yrs. The Aztecs and the ancient Egyptians used manual traction and made splints out of tree branches and bark. (19)

In 1847, Malgaigne introduced the first effective device which grasped the bone itself, these hooks were designed for the Rx of displaced patella fractures, the hooks were pressed through the skin and subcutaneous tissue to engage the proximal and distal fragment of the patella.(18)

During World War One there was a rapid spread of the use of skeletal traction by application of tongs to the femoral condyles. After the war the tongs were extensively used in the United States but their popularity gradually decreased because of the complications, particularly infection associated with their use, tongs are now mainly reserved for skull traction.(21,22,23,24,25)

Skeletal traction by means of the Steinman pin was popularized by Bohler and his students. Isotonic traction still remains an essential element in the closed treatment of many fractures.

In many places worldwide it is standard practice to apply skeletal or skin traction to the injured limb following acute fractures prior to surgery Billsten 1996; Brink, 2005 (41).

Traction may be either skin or skeletal. The main theoretical advantages of traction are that it will reduce pain at the fracture site and assist the reduction of the fracture thereby making the subsequent operation easier to perform. For intracapsular fractures reduction in circulatory complications has been proposed as traction may reduce any tamponade effect (Pressure caused by build up of excess fluid) which will compress blood vessels and block blood flow within the joint.

Traction however has potential disadvantages, it makes nursing of the patients more difficult for e.g. use of a bed pan by the patient, pressure area care prior to surgery. Other adverse effects especially of skeletal traction include complications of sepsis at the pin site, pulmonary complications and knee stiffness because of the prolonged immobilization.

In the last two decades there have been major changes in the management of lower limb long bone fractures, where resources permit, surgical management of open & closed femoral & tibial fractures has become routine.(26) Traction should now be rarely used as the definitive form of management. Orthopaedic surgeons have come to appreciate that there are 4 main treatment goals for fracture management (27). These goals were created by the ASIF – (association for the study of internal fixation) and are:

Anatomic reduction of the number fragments, ensuring alignment, length, and angulation and rotation are corrected as required.

Stable internal fixation to fulfil bio-mechanical demands

Preservation of blood supply to the injured area of the extremity.

Active pain free mobilization of adjacent muscles and joints to prevent the development of fracture disease

There are several studies done to determine the usefulness of pre-op traction, (32,33,34,,35,36,37,38,39), though these studies are mainly looking at proximal femoral fractures.

Traction prior to surgery is standard practise in some hospitals, a survey of 78 hospitals in Sweden (40) showed that a quarter of those, routinely applied skin traction to all patients with hip fractures, while another survey done by Brink et al in 2005(41) found that pre-op traction was standard practise in 20% of trauma departments in the Netherlands.

These studies have shortfalls in that the type of traction used is mainly skin fraction, and the maximum duration patients are on traction is 2.3 days Brink 2005(41), while in our setting patients are on traction for minimum one week prior to internal fixation . In this study only 4 patients were put on skeletal traction of the total patients put on traction, reasons for the difference are not given.

From the Cochrane review article on the pre-op benefits of traction, not many studies have looked at the complications of patients put on skeletal traction.

The main outcome measures in these studies (32,33,34,35,36,37,38,39,40,41) were degree of pain, analgesia use, length of surgery, ease of fracture reduction, and it seems like incidence of pressure sores and other complications were secondary objectives.

One of the earliest accounts of complications of skeletal traction is from 1946, by Kirby & Fills (42) they mainly looked at complications associated with trans-fixation pins and wires in skeletal traction, from a series of 305 fractures of long bones, complications occurred in 12, of these only 3 were related with Steinman pin use – one of the patients had pin tract infection (PTI), and 2 had peroneal nerve palsy, however the author clearly states many patients who had a little drainage from the pin but no signs of inflammation were not regarded as pin tract infection .

Pin tract infection is defined as an abnormal condition associated with skeletal traction or external fixation devices and is characterized by infection of superficial, deeper or soft tissues or by osteomyelitis. These infections may develop at skeletal traction pin sites. Some of the signs of pin tract infection are erythema at the pin sites, drainage, pin loosening, elevated temperature, and pain.

The bone pin construct is not a sterile interface, but it is a pathway between the surface of the skin, which is normally colonized by bacteria, and the medullary cavity which is sterile (43).

Factors which predispose to pin tract infection are thermal necrosis (44) and accumulation of fluid around the pin (45). Regular pin care prevents crusting around the pins, thus minimizing fluid accumulation and hence transmission of bacteria, within the underlying tissues (45).

Pin insertion using a hammer leads to splintering of the cortex (46). Insertion of the pin using power tools has been indicated as the main cause of thermal necrosis (44) hence hand drills are preferable for insertion. Necrosis of osteophytes and tissues due to the temperature elevation provide a fertile bed for any pathogenic bacteria.

Patients who are put on skeletal traction suffer from morbidities associated with prolonged bed rest. A feature peculiar to these patients is morbidities associated with pin tract infections, which results in pain, pin loosening and subsequently need for removal of the pin. Neglect in these cases can lead to abscess formation and osteomyelitis (43).

Similar morbidity of pin tract infection is associated with pins used in external fixators. Reported incidence in the world literature on pin tract infection is 5-10% (47,48,49,50). This incidence increases in cases of transfixation pins upto about 80% (51).

The prevalence of pin tract infection varies dramatically in the literature from a 1% prevalence of major infections to an 80% prevalence of minor infections (52). Even in the study identified by the Cochrane review (53) the prevalence of pin tract infection varied, based on the treatment of pin sites, from 8-25% (54).

A common factor in most studies of pin site complication is the lack of a standard definition of what constitutes a PTI is it inflammation around the pin site as reported in upto 41.6% in one series (55), or is it cellulitis around the pins or pin sites with draining sero-purulent discharge or is it pin loosening.

Therefore this study is being done to establish what the rates of pin tract infection are when all the signs of inflammation will be used to diagnose pin tract infection.

Looking at studies done closer to home in 1962 procter reported his series of 41 patients in SA (56), he was looking at use of perkins traction in femoral fracture management. PTI was found in 15% of the patients, while all the patients had full knee ROM at a period of 10 weeks. A few years later Usdin reported his own series of 58 patients, managed by perkins traction, and 5 of these patients 8.6% developed pin tract infections, and 2 cases had residual knee stiffness (57).

More recently Gosselin in his series of 53 patients from Sierra Leone in 2005 reported that 23 patients (42.6%) of his patients had a pin tract infection and at an average 29 days after being put on traction.(59)

Therefore it is noted incidence of PTI varies from centre to centre and is dependent on several factors , it is the purpose of this study to establish what proportion of patients on skeletal traction develop a PTI.

Other complications associated with skeletal traction are decubitus ulcers, venous thromboembolism, Knee stiffness and pneumonia. There is sparse literature which reports on the occurrence of these complications in association with skeletal traction.

Butt et al in his RCT of operative versus non-operative treatment of distal femoral fractures found that in the non-operative arm, a total of 26 patients developed complications. 3 of these patients had DVT, 4 had chest infections, 4 had pressure sores, 4 had UTI’s (58) and 5 out of 26 patients developed pin tract infection.

When critically ill patients are under our care it is important to protect them from further deterioration or delays in recovery, especially due to complications that are not related to the underlying pathophysiology that brought the patient to hospital.

Immobility is associated with increased risk of VTE, decubitus ulcers and pulmonary insufficiency. Bed rest is a highly un-physiologic form of therapy and can lead to a number of complications (table1).

Immobility-Associated Complications

System

Complications

Respiratory

Atelectasis

Pneumonia

Pulmonary embolus

Cardiovascular

Hypovolemia

Dampened carotid baroreceptor response

Orthostatic hypotension

Deep venous thrombosis

Gastrointestinal

Constipation

Ileus

Renal

Renal calculi

Urinary stasis

Endocrine

Hyperglycemia

Insulin resistance

Musculoskeletal

Muscular atrophy and deconditioning

Bone demineralization

Joint contractures

Skin

Decubitus ulcers

Psychosocial

Depression

Decreased functional capacity

Decreased respiratory excursion and stasis of secretions leads to atelectasis and pneumonia, lesser muscle contractions of the lower limbs results in reduced venous return, venous stasis and VTE.

Reconditioning, loss of skeletal muscle mass and strength, is often seen because of immobilization. Bone demineralization due to absence of weight bearing stress on the skeleton, joint contraction occurs because of muscle atrophy.

Pressure sores develop because of prolonged pressure on bony prominences.

DVT and PE have long been recognized as major causes of morbidity and mortality in patients undergoing both elective and emergency orthopedic surgery. Numerous studies have investigated the incidence of DVT & PE associated with hip and total knee arthroplasty, also the role of prophylactic anti-coagulation has been extremely investigated.

When considering orthopedic trauma patients extrapolation from the arthroplasty literature is not appropriate. The incidence of DVT & PE in association with hip and pelvic fracture has been looked at extensively, however there is insufficient information on patients with femoral fractures managed with skeletal traction, so as to allow the orthopedic surgeon to determine the risk or benefit rational of anti coagulation.

In a prospective study done in Canada a co-host of 349 following major trauma was studied, and DVT cross found in 126 of the 182 with lower extremity orthopedic injuries, 61% of patients with pelvic fractures, 80% of patients with femoral fractures, 77% of patients with tibia fractures had confirmed DVT using venographic studies. Patients with fracture of tibia, femur are known to be at almost a 5 times more risk to have DVT as compared to patients without fractures. Geerts et al also found that only 3 of the 201 patients with confirmed DVT (ODS 1.5%) had clinical characteristics suggestive of DVT, therefore it is questionable whether clinical characteristics are adequate to make a diagnosis of DVT.

Although it is well known that elderly patients have an increased risk of thrombosis. Geerts et al also found that younger patients with trauma those that are under 30years had a 46% incidence of DVT.

The incidence of DVT in patients with femoral fractures on skeletal traction is unknown. The purpose of this study is to determine the incidence of DVT with positive clinical characteristics and confirmed by Doppler U/S in patients on skeletal traction for femoral fractures.

Respiratory problems are common after long bone fractures, The main common complication of long bone fracture is fat embolism syndrome (FES),(60) followed by respiratory dysfunction and insufficiency.(61,62)

Despite the development of medical and anesthetic management, evidence indicates that early treatment of the fractures in a multiply injured patient has a profound effect in reducing the risk of subsequent respiratory complications. (61,63,64,65,66)

There are numerous studies showing that early fixation of femoral fractures can decrease the incidence of ARDS and multiple organ failure (MOF).(67,68,69,70,71,65) Over the last decade the beneficial effects of early stabilization of femoral shaft fractures by intramedullary nailing have been challenged. The association between early femoral fixation with reamed nailing and a higher risk of ARDS/MOF has been suggested.(56,64,60,61,65,66,)

The first prospective study on this subject showed that among 178 patients, the incidence of pulmonary complications was significantly higher in those with late stabilized fracture.(71) In patients with single fracture, the complication rate after late fixation was 22% in comparison with 4% after early stabilization. In multiple fractures, these rates the traction were100% and 32%, respectively.(69,70)

Early fixation can lead to the prevention of thrombosis, subsequent bed ulcers, and decreases the needs for analgesics.(65,74) Furthermore, early stabilization eliminates the need for supine position for skeletal traction, it improves pulmonary function and prevents atelectasis.(63,65,67,74,75)

This study is aimed to determine the incidence of respiratory problems in patients who have single femoral or multiple fractures, and are awaiting operative stabilization.

Severely restricted knee motion is a recognized complication of operative procedures or trauma around the knee. This is a significant problem in underdeveloped countries where the initial management of many of these injuries is suboptimal. The reported rate (76,77,78,79) of significant knee stiffness after various injuries and procedures around the knee is as high as 11% in the western literature, but may be much higher in underdeveloped countries, where ideal management of trauma is not readily available (80). A large percentage of these cases present with adhesions inside as well as outside the knee, and the management of these cases then becomes complex.

Loss of extension is labelled more debilitating in western cultures, with small extension deficits impeding normal walking ; restricted flexion however is a serious problem in the Asian countries, where social and religious mores make sitting on the ground a normal requirement of everyday life. Flexion loss is mostly due to intra-articular fibrosis and scarring in the quadriceps-femoral mechanism. Anterior adhesions involve the quadriceps expansion in the lateral and medial recesses, the suprapatellar bursa, muscle adhesions to the femur, patella , or even shortening of the rectus femoris (77).

A number of studies have described the complications of traction however no study from the region where patients are primarily managed on skeletal traction have looked at the complications due to skeletal traction and those associated with prolonged immobilization.

STUDY JUSTIFICATION:-

American College of Surgeons Committee on Trauma has recommended that femoral shaft fractures in polytrauma patients be treated within 2-12 hours after injury, provided they are hemodynamically stable.(81,82) Studies have also shown the significant benefit of intervention within the first 24 hours. Immediate fixation has been shown to decrease fatalities, respiratory complications, multisystem organ failure, and the length of ICU stays in most patients. The type of early fixation used can be debated, but the timing appears to be what makes the difference (83,84).

World over fracture fixation has evolved whereby early fixation is advocated for. In the resource-poor local setting with large volumes of patients occasioned by persistently high RTA, the primary management modality is skeletal traction.

There is lack of skilled personnel (surgeons/traumatologists) in most peripheral hospitals and hence most patients who have sustained fractures of the lower limb are put on skeletal traction as ORIF cannot be done therefore it is important to establish what are the common complications suffered by these patients.

There is a large volume of patients who are seen at KNH, this is mainly because of the poor infrastructure at peripheral hospitals in managing major orthopaedic injuries hence most patients are referred to KNH causing a strain on its resources and ultimately leading to substandard orthopaedic care.

The complications associated with skeletal traction and prolonged immobilization have been reported by several authors however most of the numbers of patients who are managed on skeletal traction in these studies are few. In our setup most of the patients with femoral fractures are put on skeletal traction while awaiting operative management therefore it is important to know what the incidence of these complications in our setting are.

The incidence of pin tract infection in most studies is not adequately reported as there is no standardized definition of pin tract infection therefore this study will look at pin tract infection broadly .

In KNH patients with femoral fractures are put on skeletal traction while awaiting fixation, this is mostly done on an elective operating list and it is not known what duration these patients are on traction, from this study we will establish what the mean waiting time is for a patient with femoral fracture to be internally fixed.

It is not known what number of patient’s with femoral fractures who are put on traction in our setting develop complications hence this study is being done to establish the proportion of patients who get pin tract infections, and other complications associated with skeletal traction.

BROAD OBJECTIVE:-

To determine the proportion of patients with Lower Extremity fractures who develop complications associated with skeletal traction.

SPECIFIC OBJECTIVE:-

To determine the proportion of patients on skeletal traction for LE fracture who develop

pin tract infections

venous thrombo-embolism

knee stiffness

pressure sores

orthostatic pneumonia

2. Determine the proportion of those who recover from the complications

3. To determine the duration patient’s are on traction

4. Proportion of those with adverse outcomes following complications

PATIENTS AND METHODS

STUDY DESIGN

This is a Hospital based Prospective Descriptive study.

STUDY SETTING:-

The study will be carried out at the KNH orthopaedic wards.

STUDY PERIOD:-

The study will be carried out over a period of four months or?until the sample size is achieved

SELECTION CRITERIA :-

All patients eligible to the study will be enrolled until the sample size is obtained.

INCLUSION CRITERIA:-

All skeletally-mature pts with lower extremity fractures put on skeletal traction as a definitive or temporary treatment option

Those consenting to be recruited in to the study.

EXCLUSION CRITERIA:-

Skeletal immaturity determined radiologically.

Pre existing disease: pneumonia, VTE, pressure sores

SAMPLE SIZE CALCULATION:-

The sample size will be determined by the use of the following formulae to achieve an adequate sample to accurately estimate the prevalence of complications in pin tract infection in the study population.

n = Z2α/2 X P (1-P)

D2

Where n = required sample size

P = prevalence of pin tract infection (42.6%, 24% [1] , 26% [2] ), based on the estimated prevalence from a similar study in Sierra Leon by Gosselin. This is the only study in the developing country performed in a similar setting.

D = Precision with which to measure prevalence, set at plus or minus 1%.

The Zα/2 is the cut off points along the x-axis of the standard normal probability distribution that represents probability matching the 95% confidence interval (1.96).

Substituting the above in the formulae we get;

n ≈ 93.9

= 94 patients

DEFINITIONS OF COMPLICATIONS AS WILL BE USED IN DATA COLLECTION :-

Pin Tract Infection :- will be defined by signs of hyperemia,pain,crusts,seropurulent discharge around the pin site or pin loosening.

Venous Thrombo-embolism :- Patients with unilateral leg swelling, calf pain, will be subjected to doppler u/s to confirm presence of a thrombus.

Pressure sores : Trochanteric,sacral,calcaneal regions of the body will be examined and the use of the pressure sore grading system will be used to record presence of pressure sores :-

Grade 1 :- non blanchable erythema of intact skin

Grade 2:- Partial thickness skin loss involving epidermis,dermis or both

Grade 3:- Full thickness skin loss involving damage o or necrosis of subcuataneous tissues that may extend down to but not through underlying fascia

Grade 4 :- Full thickness skin losswith extensive destruction, tissue necrosis or damage to muscle or bone.

Knee Stiffness :- Patients have a reduced range of motion of the knee of the injured limb and will determined by range of motion of less than 30 degrees, less than or equal to 90 degrees or more than 90 degrees.

Pneumonia :- Patients who have recorded high temperatures, respiratory distress, cough, chest pain will be used to make a diagnosis of pneumonia.

DATA COLLECTION:-

Patients will be recruited into the study Consecutively

Use of a questionnaire to gather data, including demographics, cause of fracture, traction system and its duration, incidence of complications and their outcome.

Data will be collected as pertains to the date of commencement of traction up to the date patient undergoes operative management or is taken off traction.

Patients will be recruited into the study as they are put on traction, and will be followed upto the time they are taken off traction.

DATA ANALYSIS:-

The data will be collected using a structured questionnaire. The questionnaires will be coded to make the data entry easy. The filled questionnaires will be kept in a safe place ready for the data entry and for the confidentiality of the patient’s details.

After cross checking the questionnaires for any missing entries a data base will be designed in MS Access which will allow the researcher to set controls and validation of the variables. On completion of the data entry exercise the data will be exported in a Statistical Package (SPSS – Version 15.0 Chicago , Illinois) for analysis.

The data will be presented in tables and figures where applicable. Non- Parametric tests (Mann Whitney U test) will be used to examine whether there is any significant association between the continuous variables e.g. age and duration count, while chi-square will be used to establish the significant associations between the categorical variables.

Odds Ratios (OR) and associated 95%Confidence interval (CI) will be calculated to identify the factors that are more likely to explain the explanatory variable (complication). P-value of less than 5% (P<0.05) will be considered statistically significant.

Comparisons will be done between patients (e.g time in traction) and any associations will be looked at using the t – test.

Descriptive statistics will be applied to the data collected and Continuous data will be summarized using mean, standard deviation, median, minimum and maximum while frequencies and percentages will be used for categorical or nominal data.

Kaplan Meier to follow entry and exit points as patients

ETHICAL CONSIDERATIONS

After presentation and approval at the University of Nairobi’s Department of Surgery, Ethical approval will be sought from the Kenyatta National Hospital Ethical and Research Committee.

Confidentiality is guaranteed to each patient from the data obtained.

Patients will be allowed to withdraw at any point of the study should they choose to do so.

CONSENT

Informed consent will be sought from the patients.

TIMETABLE

March 2010 to November 2010

Proposal writing and submission for ethical approval

December 2010 to March 2010

Data collection and analysis

April 2010

Dissertation writing

May 2010

Presentation of results

BUDGET ESTIMATES

ITEM

COST (Kshs.)

1

Research fee (KNH-ERC)

1,500.00

2

Typing and printing expenses

5,000.00

3

Photocopying expenses

Telephone Expenses

Data Collection/ResearchAssistants

5,000.00

5,000.00

7,000.00

4

Data Analysis:

a) Personnel

10,000.00

b) Data storage

5,000.00

5

Contingencies

6,000.00

Total

44,500.00

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APPENDIX 1

CONSENT BY THE PARTICIPATING PATIENT/ GUARDIAN

Study No……………….

Hospital No……………..

Purpose of the study

The purpose of this study is to document the incidence of pin tract infections and other complications associated with skeletal traction.

Risks and benefits

This study will provide clinicians essential information on the pattern and frequency of the complications that occur with skeletal traction. There is no harm or risk anticipated for participating in this study. Taking part in this study does not exclude you from receiving operative management for the fracture you have sustained.

Voluntary participation

Participation in this study is out of your own free will. Medical care will not be denied to you in case you decline to participate in the study. You may terminate participation at any time with no consequences whatsoever.

Confidentiality

All information will be treated with confidentiality.

I the undersigned have been explained to and understand the above and voluntarily accept to participate in the study.

Signature/Thumb print:

(Parent/Guardian) ………………

Telephone number (parent/ guardian): …………

For any enquiries or further clarification, please contact the following people

1. DR MUSTAFA MUSAJEE TEL : – 0734 867251

2. DR. P. MUNGAI – NGUGI, CHAIRMAN, KENYATTA NATIONAL HOSPITAL ETHICS & RESEARCH COMMITTEE – Tel 0722 708806