RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA
ANNEXURE 2PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / NAME OF THE CANDIDATE AND ADDRESS. / DR KUMARASWAMY. P
PG IN GENERAL SURGERY
KARNATAKA INSTITUTE OF
MEDICAL SCIENCE,
HUBLI – 580022
2. / NAME OF THE INSTITUTION. / KARNATAKA INSTITUTE OF MEDICAL SCIENCES, HUBLI
3. / COURSE OF STUDY AND SUBJECT / M.S. GENERAL SURGERY
4. / DATE OF ADMISSION / 02-05-2009
5. / TITLE OF THE TOPIC / “A COMPARATIVE STUDY OF COLLAGEN DRESSING VERSUS 1% SILVER SULPHADIAZINE DRESSINGS IN PARTIAL THICKNESS BURNS”.
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6. BRIEF RESUME OF THE INTENDED WORK
6.1 NEED FOR THE STUDYBurns injuries are extremely complex and optimal treatment requires an understanding of nutrition, immunology, psychological issues, the physiology and the metabolic interactions among all the major organ systems. When skin is burnt, its functions are lost and the loss of stratum corneum allows invasion of micro organisms.
Traditionally the management of superficial burns has been a method of exposure, but with the changing times now the impetus of management is towards closed dressings with newer types of dressings.( which has same properties of skin)
Collagen is an endogenous substance, which forms an important structural component in connective tissue and is of special importance in the skin. The importance of collagen in healing has been appreciated for many years for the simple reason that, the end result of repair in wound healing in always a scar, which is composed of collagenous fibers.
In this study the results of occlusive dressing of collagen sheet on superficial burns is compared with the traditional method of open treatment using topical antibiotic.
6.2REVIEW OF LITERATURE
1) Gupta RL, et al.
Collagen sheet cover was used in 32 cases of fresh burns and 26 cases of post burn contractures.
In majority of cases of burns, the collagen sheet remained dry and there was no infection. It safeguards against exogenous infection, prevented exudation from the raw areas and provided rapid epithelialisation and healing.
2)Gerding RL, Emerman CL and Efforn D ,et al.
A randomized, prospective study comparing the use of Biobrane with the use of 1% Silver sulfadiazine in treating 56 partial thickness burn wounds was carried out in outpatients with burns that comprised less than 10% of their total body surface area. The two groups were compared for healing time, pain, compliance with scheduled visits. Infection rates in two groups were similar. Healing times of Biobrane treated wounds were significantly less than those of 1% silver sulphadiazine treated wounds.(10.6+/-0.8 vs. 15.0 +/-1.2 days, P<0.01). Using a pain scale of 1 to 5, Biobrane treated patients averaged lower pain scores at 24 hrs after the burn(1.6+/-0.8 vs 3.6+/-1.3, P<0.001). We conclude that when used on properly selected wounds Biobrane therapy can significantly decrease pain and total healing time. Improved patient compliance may be added benefit.
3)Demling RH, Desanti L,et al.
This study compared the effect of standard topical antibiotic management versus a biological skin substitute wound closure for mid-dermal facial burns of the face. Adult patients with mid-dermal facial burns produced by flash flames or flame exposure were studied using a randomized prospective study design. Total daily burn time, pain (0-10 scale) and healing time were monitored. 21 patients were studied, with 10 patients in skin substitute group made up of bio engineered skin substitute coated with fibronectin and 11 patients treated by open technique with bacitracin ointment. We found a significant decrease in wound care time 0.35+/-0.1 versus 1.9+/-0.5h, decrease in pain of 2+/-1 versus 4+/-2 and re-epithelialisation time 7+/- 2 versus 13+/-4 days in the skin substitute group compared to topical antibiotics. We can conclude that a bioengineered skin substitute significantly improves the management and healing rate of partial thickness facial burns, compared to the standard open topical ointment technique.
4) Barret, Jaun P.M.D et, al
Twenty pediatric patients were prospectively randomized in two groups to compare the efficacy of Biobrane versus 1% silver sulphadiazine. Demographic data, wound healing time, length of hospital stay, pain assessment and pain medication requirement, and infection were analyzed and compared. Main outcome measures included pain, pain medication requirement, wound healing time, length of hospital stay, and infection.
The application of Biobrane to partial-thickness burns proved to be superior to the topical treatment. Patients included in the biosynthetic temporary cover group presented with less pain and required less pain medication. Length of hospital stay and wound healing time were also significantly shorter in the Biobrane group. None of the patients in either group presented with wound infection or needed skin autograft.
5) Mukund B Tayade, Girish D Bakhshi et, al.
A prospective comparative study comprising of 50 patients were divided into 2 groups, test group treated by collagen dressings and control group treated by 1% silver sulphadiazine. Majority of the patients had less than 10% burns in both the groups. The two groups were compatible with each other in respect of age, sex ratio and type of burns. The average pain levels were 2.64 in control group and 1.2 in test group using VAS system after 24 hours. The healing time required in control group was an average of 18.44 days whereas in the test group it was 12.64 days. The complications observed were infection followed by conversion to 3rd degree burns in 2 patients in control group and 1 patient in test group. Thus collagen sheet promotes early healing, reduces pain and decrease the need of analgesics and decreases associated complications as compared to the conventional topical SSD dressing. The morbidity of the affected patients is reduced using collagen.
6) Marilyn Kwolek, Dhanikachalam, R P Narayan et,al.
43 patients (aged 1 to 57 years) of either sex, with deep second- degree burn injury ranging 8% to 40% of the body surface area, were randomized to receive the type-1 collagen dressing or 1% silver sulphadiazine. 23 patients were randomly allocated to receive collagen dressings and 22 to silver sulphadiazine.2 patients in silver sulphadiazine group lost follow up, thus a total of 43 patients were evaluated.
It was observed that collagen dressing caused significantly more rapid re-epithelialization of burns, i.e., a shorter time for healing, than silver sulphadiazine group. Statistical analysis showed that median time to heal was 7.2 days in collagen group versus 14.5 days in the silver sulphadiazine group. The recorded difference 7.3 days was stastically significant (p+0.005). There was a 49.7% enhanced healing with the collagen group compared to silver sulphadiazine group. The observation also concludes shorter time to healing caused by collagen dressing is clinically relevant and further demonstrates the wound healing activity of type-1 collagen.
6.3 OBJECTIVES OF STUDY:
To compare the efficacy and safety of collagen dressings and 1% silver sulphadiazine in partial thickness burns in terms of reduced pain, healing time, healing quality and complications.
7. MATERIALS AND METHODS
7.1 SOURCE OF DATA
Data shall be collected from all patients with partial thickness burns who are salvageable (<40% BSA) admitted during period of December 2009 to November 2010 will be taken for study considering the inclusion and exclusion criteria.
7..2 METHOD OF COLLECTION OF DATA
Information will be collected through predesigned pretested proforma for each patient.
Ø All patients will be interviewed as per the proforma and a complete clinical examination will be done.
Ø Cases with second-degree burns who are salvageable (<40%BSA) are assessed.
Ø Cases will be allocated randomly into test group and control group, test group treated with collagen dressing and control group treated with 1% silver sulphadiazine.
Ø Groups are done taking into account the confounding factors, which are matched.
Ø Cases are assessed for healing time, pain, healing quality and complications in both the groups.
· Sample size
As per the hospital statistic, 278 patients were admitted in Burns Department of Surgery, KIMS, Hubli in the year 2008. Out of which110, patients were partial thickness burns who were salvageable ( < 40% BSA. This gives the prevalence of 39.4% with confidence interval of 95% and 5% permissible error. Sample size comes out to be 100 cases. However, this being a time bound study, all the patients admitted with partial thickness burns in surgical ward during this period will be taken for study.
· Inclusion criteria
All patients with partial thickness burns, who are salvageable (40%BSA) and Burn wounds not older than 48hours.
· Exclusion criteria
Ø Patient with full thickness burns.
Ø Patients who are not salvageable (>50% BSA).
Ø Patient with electrical and other non-thermal burns.
Ø Patient with burnt wounds older than 48 hours
Period of follow-up
Patients will be followed up on day 1, 2, 7,14,21,28 or for more days in events of any adverse effects related to the medication or aggravation of symptoms or complications. All patients will be followed up until complete epithelialisation, which will be considered as the end point. All patient will be assessed for pain using Visual analogue scale.
· Statistical tests:
The collected data will be evaluated using appropriate statistical methods.
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER
HUMANS OR ANIMALS? IF SO DESCRIBE BRIEFLY.
Yes,
1. Blood investigations- Hb, Total count, Differential count, PCV, serum albumin, total proteins, RBS.
2. Culture and sensitivity.
7.4 HAS THE ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3?
Yes, ethical clearance has been obtained from the ethical committee of KIMS Hubli.
8. LIST OF REFERENCES
1) Gupta RL, et al. Role of collagen sheet cover in burns- a clinical study. Indian journal of surgery 1978; 40(12):646.
2) Gerding RL, Emerman CL and Effron D,et al. Outpatient management of partial thickness burns: biobrane versus 1% silver sulphadiazine. Annals of Emergency
Medicine 1990;19:121.
3) Demling RH. Desanti L, Management of partial thickness facial burns ( comparision of topical antibiotics and bioengineered skin substitutes). Journal of Burn Care and Rehabilitation1999;25:256.
4) Juan P Barret, et al. Biobrane versus 1% silver sulphadiazine in second degree pediatric burns. Plastic and Reconstructive Surgery 1999;105(1):62-65.
5) Mukund B Tayade, Girish D Bakhshi et al. A comparative study of collagen sheet cover versus 1% silver sulphadiazine in partial thickness burns. Bombay hospital Journal.2004.
6) Marily Kwolek, Dhanikachalam, R P Narayan et al. A comparative second-degree burn treatment trial of collagen dressing versus silver sulphadiazine alone at 31st annual meeting of society for biomaterials, 2006.
9 / Signature of candidate
10 / Remarks of guide
11 / Name and designation
11.1 Guide / DR RAVINDRA ELIGAR MS, MCh.
PLASTIC SURGEON,
ASSOCIATE PROFESSOR,
DEPT OF GENERAL SURGERY, KIMS, HUBLI.
11.2 Signature
11.3 Head of the department / DR M B BARIGIDAD MS
PROFESSOR AND HEAD OF
DEPT OF GENERAL SURGERY,
KIMS, HUBLI.
11.4 Signature
12 / 12.1 Remarks of the Chairman and principal
12.2 Signature
FROM,
DR KUMARASWAMY P
POST GRADUATE,
DEPARTMENT OFGENERAL SURGERY,
KIMS, HUBLI
TO,
THE PRINCIPAL
KIMS, HUBLI.
(THROUGH PROPER CHANNEL)
Respected sir,
Sub: Submission of proforma for registration of subject for Dissertation.
I am here with submitting my proforma for registration of dissertation titled “A COMPARATIVE STUDY OF COLLAGEN DRESSING VERSUS 1% SILVER SULPHADIAZINE DRESSINGS IN PARTIAL THICKNESS BURNS”. Kindly forward this to RGUHS, Bangalore.
Thanking you,
Yours sincerely,
DR.KUMARASWAMY P
Place: Hubli
Date:
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