SYNOPSIS FOR DISSERTATION SUBMISSON IN RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE.

1. / Name of the candidate and address (in block letters) / DR.PIYUSH RANJAN
POSTGRADUATE STUDENT,
DEPARTMENT OF GENERAL SURGERY,
S.NIJALINGAPPA MEDICAL COLLEGE,
BAGALKOT – 587102
2. / Name of the institution / S. NIJALINGAPPA MEDICAL COLLEGE AND HANAGAL SHRI KUMARESHWAR HOSPITAL AND RESEARCH CENTRE ,
NAVANAGAR, BAGALKOT – 587102
3. / Course of the study and subject / MS (GENERAL SURGERY)
4. / Date of admission to the course / 31ST JULY 2013
5. / Title of the Dissertation / “COMPARATIVE STUDY OF STAINLESS STEEL STAPLES CLOSURE OF SKIN WOUND VERSUS 3-0 ETHILONE CLOSURE”
6. / Brief resume of the intended work
6.1 / Need for the study
Sutures have the disadvantage of consuming more time in applying and with a cosmetically inferior scar. Closure in case of staple use is 5-7 times faster in comparision to sutures. 56% of elective cases in whom suture closure was used, had a pain score of 3 or higher compared to only 17.2% in staple closure group. Post operative wound infection rate is 13.7% in staple group and 12% in suture group. scars compared 3 months after surgery showed better cosmetic results with staples in elective cases.1
Stapling is a fast, comfortable method of closing many of the lacerations that present to an emergency department. In some situations, the speed of stapling may compensate for its expense. In this study, this method was highly acceptable to the participating emergency physicians, and their parents. The clinical and cosmetic outcome of the stapled wound was virtually identical to that of sutured wounds. When this method of closure is selected, it is important to inform the patient that a special staple remover is required, so that he or she can either ensure that the family physician has such a remover, or return to the emergency department for removal.2
Choosing a method of closure that affords technically easy and efficient procedure with a secured closure and minimal pain and scarring, is paramount to any surgeon. Staple closure also eliminates the risk that a health care provider will experience a needle stick, which is a particularly important consideration in caring for trauma patients with unknown medical histories.3
Few studies have been conducted to evaluate the difference in stainless steel staples and ethilone 3-0.
In the view of above context the present study is undertaken to evaluvate the effect on wound healing with the use of 3-0 Ethilone and staples, postoperative infection rate, cosmetic results and time taken for closure of skin wounds, closure of skin wound, cost effectiveness.
6.2 / Review of Literature
Stapling is a fast, comfortable method of closing many of the lacerations that present to an emergency department. In some situations,the speed of stapling may compensate for its expense.In this study,this method was highly acceptable to the participating emergency physicians,and their parents.The clinical and cosmetic outcome of the stapled wound was virtually identical to that of sutured wounds.When this method of closure is selected,it is important to inform the patient that a special staple remover is required,so that he or she can either ensure that the family physician has such a remover, or return to the emergency department for removal.2
Studies have concluded that though the staples cost higher in comparison to sutures, the wound closure time was much faster which was statistically significant and in agreement with the literature reviewed. This has a great impact on post operative recovery as the patient can be weaned off from the anaesthesia faster and thereby reducing overall operating time and hence decreasing post operative morbidity and mortality. In terms of patient acceptance of a scar they conclude that staples have good acceptance in clean elective cases and they are met with significant post operative wound infection in contaminated and emergency cases. Since staples are easier and faster to apply compared to sutures, the study showed that form an important surgical armamentarium for wound closure for elective and clean cases.1
One study has revealed a higher complication rate in wounds closed by staples compared with those closed by nylon vertical mattress suture. Uncomplicated wounds from both type of closure have exhibited similar cosmetic appearances. Staples were invariably more painful to remove. Both suturing and stapling are technical acts requiring care and both have to be learned; they attempted to employ both methods with appropriate accuracy. The only advantage of stapling is its speed of execution and it is difficult to balance this with the higher cost and increased complication rates. Which is stated with some regret because, undoubtedly, at the end of a lengthy procedure, it is so pleasurable to use a skin stapler.4
Of the five randomized controlled trial in cardiovascular surgery that compared staples with suture closure three of the five studies found that the complication rate was lower with sutures and other two found no difference. With regard to cosmesis two of the five studies found sutures to be superior and the remaining found no difference. They conclude that sutured skin closure for leg and chest wound is superior to stapled closure.5
Similar studies in orthopaedic concluded the risk of infection after staple closure was three times the risk with suture closure; after hip surgery the risk was four times greater.6
6.3 / Objectives of the study
1) To study the time taken for closure of skin
2) To study the effect on wound healing with the use of 3-0 Ethilone and staples
3) To study the post operative complications.
4) To study the cosmetic results of 3-0 Ethilone and Skin staples
5) To study the cost effectiveness
7 / Materials and methods
7.1 / This is one and a half year study of all cases of elective surgeries that will be conducted in all unit of surgery in S.N. Medical College and H.S.K. Hospital and Research Centre, Bagalkot from14 january 2014 to14 june 2015
7.2 / Methods of collection of data (including sampling procedure, if any )
Design of study: Prospective Randomised Controlled Study
Study period:18 months
Sample size: patient coming for the elective surgery in HSK hospital from January 2014 to June 2015.
Sample size calculation done using Open Epi software version 2.3.1
At 95% confidence level, 90% of power of Study according to study done by Dr. Chandrashekar N.1
The wound infection in group 1: 38%
The wound infection in group 2: 16%
The sample size calculation done using N= 2(Zα+Zβ)2 p (1- p)
d2
Hence the Sample size calculated is 180
90 in each group
90 in Staples closure group
90 in 3-0 Ethilone closure group
Inclusion criteria for the study group:
1)All patients undergoing any kind of skin closure in elective surgery
2)Both the sexes are included
Exclusion criteria for the study group:
1)Patient undergoing emergency surgery.
2)Secondary closure of infected wound.
3)Wound dehiscence.
Statistical analysis: Data will be analyzed statistically by chi square test for qualitative data and t- test for quantitative data.
7.3 / Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly.
Yes
The study requires suturing as an intervention for skin closure either with Ethilone 3-0 or stainless skin staples.
7.4. / Has ethical clearance been obtained from your institution in case of 7.3?
Yes
Ethical clearance has been obtained from “Institutional Ethical Committee” of S. N. Medical College, Bagalkot.
8. / List of References:
  1. Dr. Chandrashekar N., Dr. Prabhakar G.N., Dr. Shivakumarappa G.M., Dr.Fahad Tauheed. “Acomparative study between skin sutures and skin staples in abdominal surgical wound closure”. Journal of Evolution of Medical and Dental Sciences2013; Vol2, Issue 28, July;Page:5180-5186.
  2. Michael Shuster. Comparing Skin Staples to Sutures in an Emergency Department. CAN.FAM.PHYSICIAN Vol.35: MARCH 1989.
  3. Julio Hochberg, Kathleen M. Meyer, Michael D, Marion. Suture choice and other methods of skin closure. Surg Clin N Am 89 (2009) 627-641.
  4. Ian Stockley.,Reginald A. Elson. Skin closure using staples and nylon sutures: a comparision of results. Annals of the Royal College of Surgeons of England (1987) vol 69.
  5. Aliu Sanni., Joel Dunning. Staples or sutures for chest and leg wounds following cardiovascular surgery. Interact Cardiovasc Thorac Surg. 2007 Apr; 6(2):243-6.
  6. Toby O Smith, Debbie Sexton, Charles Mann, Simon Donell. Sutures versus staples for skin closure in orthopaedic surgery: meta-analysis.BMJ 2010;340:c1199

9. / Signature of the candidate
10. / Remarks of the Guide
11. / Name and designation
11.1 / Guide / dr.S.B.KUNTOJI m.s. fais.
Professor,
department of SURGERY,
s. n. medical college,
bagalkot.
11.2 / Signature
11.3 / Co-guide (if any)
11.4 / Signature
11.5 / Head of the Department / DR. E.B. KALBURGI
M.S. FAIS, FICS,FIAGES
PROFESSOR AND HEAD
DEPARTMENT OF SURGERY,
S.N. MEDICAL COLLEGE AND H.S.K. HOSPITAL & RESERCH CENTER, BAGALKOT.
11.6 / Signature
12. / 12.1 / Remarks of the Chairman and Principal
12.2 / Signature