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SYNOPSIS
Rajiv Gandhi University of Healt h Sciences, Karnataka,
Bangalore
“ ROLE AND SIDE EFFECTS OF TOPICAL PHENYTOIN
DRESSING IN DIABETIC ULCERS: A COMPARATIVE
STUDY WITH CONVENTIONAL DRESSING”
Name of the candidate
: Dr. Nita Trina D’Souza
Guide
: Dr. Leo Francis Tauro
Co-Guide
: Dr. Jacintha Martis
Course and Subject
: M.S. (General Surgery)
DEPARTMENT OF GENERAL SURGERY
FR. MULLER MEDICAL COLLEGE HOSPITAL
KANKANADY, MANGALORE – 575 002.
AUGUST - 2009
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION
1.
Name of the Candidate
and Address
[in block letters]
DR. NITA TRINA D'SOUZA
POST GRADUATE RESIDENT
DEPARTMENT OF GENERAL SURGERY
FR. MULLER MEDICAL COLLEGE
KANKANADY, MANGALORE-575002
2.
Name of the Institution
FR MULLER MEDICAL COLLEGE
HOSP ITAL KANKANADY,
MANGALORE 575 002
3.
Course of study and
subject
M.S GENERAL SURGERY
4.
Date of admission to
Course
23-04-09
5.
TITLE OF THE TOPIC:
“ ROLE AND SIDE EFFECTS OF TOPICAL PHENYTOIN
DRESSING IN DIABETIC ULCERS: A COMPARATIVE STUDY
WITH CONVENTIONAL DRESSING”
1
6.
BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:
Diabetic ulcer is the most frequent reason for hospitalization
in patients with diabetes and is a major cause of morbidit y and excess
hospital care cost for the patients. Though there are many modalities
of wound care, the problem o f treating diabetic wounds is still
enormous. Currently a lot of attention is being placed on the
development of expensive topical molecular factors for wound healing
like epidermal growth factors, tissue stimulating factor, vacuum
assisted dressing and dr essing with hyperbaric ox ygen. The efficacy of
such agents is still questionable and the cost factor should be kept in
mind. There remains a quest for better wound -healing agents. One
such agent is phenytoin which is cheap, easy to use and readil y
available for medical practice.
Phenytoin (diphenylhydantoin) was initiall y introduced into
therapy for the effective control of convulsive disorders. A common
side effect with systemic phenytoin treatment is the development of
fibrous overgrowth of gingival [ 1 ] This apparent stimulatory effect of
phenytoin on connective tissue suggested an encouraging possibili t y
for its use in wound healing [ 2 ] Phenytoin aids in healthy granulation
tissue formation and thus improves qualit y of graft bed and better
graft up take. This ensures better wound management for the patient.
Not many studies have been done regarding the side effects of topical
phenytoin used for management of diabetic ulcers necessiting the need
for one such study.
This study is done to assess the efficacy and side effects
of topical phenytoin dressing as compared to conventional wound
dressing in diabetic ulcers. Thus to know if phenytoin is a better and
cheaper alternative option in the management of diabetic ulcers.
2
6.2 REVIEW OF LITERATURE:
It was first observed in 1939 [ 1 ] that gingival hyperplasia
occurred in some patients treated with phenytoin and this stimulated the
study regarding the potential use of phenytoin in wound healing. The
first controlled clinical trial was done in 1958 [ 2 ] and it was found that
periodontal patients with surgical wounds who were pretreated with oral
phenytoin had less inflammation, less pain, and accelerated healing
compared with controls. Phenytoin was observed to be better than
sodium chloride (0.9 %) dressings in a study on
chronic
wounds
of
various
etiologies
(burns,
75 patients with
cellulitis,
trauma,
amputation stump, postoperative) [ 3 ]
The earliest clinical study of phenytoin in cutaneous wound
healing used oral phenytoin sodium to treat venous stasis ulcers in 28
patients in a double-blind, placebo-controlled trial [ 4 ] Phenytoin has also
been examined in the treatment of diabetic foot ulcers and observed to
be superior as compared to other topical appli cations [ 5 , 6 ] A study was
done by Rhodes et al [ 7 ] on the healing of stage II decubitus ulcers with
topicall y applied phenytoin sodium with two other standard topical
treatment procedures. Phenytoin was observed to aid in the healing of
the ulcer. This stu dy also included the extent of systemic absorption of
phenytoin after topical application and it was found to be negligible.
3
6.3
OBJECTIVES OF THE STUDY:
To compare the efficacy of topical phenytoin with conventional
wound dressings in hea ling of diabetic ulcers, in terms of:
7.

No of days required for healing

Rate of granulation tissue formation

Qualit y of graft bed and skin graft up take

Effect on bacterial load

Side effects of topical phenytoin dressing
MATERIALS AND METHODS:
7.1 SOURCE OF DATA:
Patients with diabetic ulcer admitted in Fr.Muller Medical
College from September 2009 to September 2011
7.2 METHOD OF COLLECTION OF DATA:
A sample of 100 patients will be selected using purposive
sampling technique. At the time of enrollment a written infor med consent
would be obtained. All patients will undergo general physical and clinical
examination for peripheral vascular status and peripheral neuropathic
changes in lower extremities. Routine hem atological, biochemical, urine
microscopic investigations will be done for each patient. After satisfying the
inclusion and exclusion criteria, the selected patients will be randoml y
assigned (using lottery method) into treatment group and control group. In
each patient one ulcer will be chosen and surgical debridement will be done
when necessary.
After slough removal, the surface area will be measured, tracing
4
the outline on butter paper. This outline will be transferred to graph paper.
On each occasion ulcer areas will be measured twice. When identical, the
reading will be recorded. If not the average will be recorded.
A single 100mg phenytoin sodium capsule will be opened and
placed in 5ml of sterile normal saline to form a suspension. Sterile gauze
will be soaked in the suspension an d placed over the wound at 20mg /cm2
TBSA. Conventional dressing will be done with 5%w/v povidone -iodine
solution. Dressings will be done on twice dail y basis. The patients will be
followed up on a dail y basis for 14 days in both study and control groups.
Wound culture will be obtained at the start of the treatment and on the 14 t h
day of treatment. Observed or spontaneousl y reported side effects (local and
systemic) will be documented. The patients will then be subjected to split
thickness skin grafting and the wounds will be assessed on fifth post
operative day for skin graft up take and the total no of days of
hospitalization will be noted. The follow up of the patients will be done at
one month after discharge in out patient department for post skin grafting
complications.
Study type:
Experimental study.
5
Inclusion Criteria:

grade I and II foot ulcers according to Meggit -Wagner clinical
classification

control of diabetes mellitus with oral hypogl ycemic agents or insulin
Exclusion criteria .

grade III,IV,V foot ulcers according to Meggit -Wagner clinical
classification

chronic ulcer of other etiology

other co morbid conditions like renal failure , generalized debilit y
which adversel y affect wound healing

Patients with allergy to phenytoin.
Plan for data - analysis
Collected data will be anal yzed by paired and unpaired‘t’ test and statistical
significance will be evaluated using chi - square test.
7.3 Does the study requi re any investigations or interventions to be
conducted on patients or other humans or animals? If so, please
describe briefly: Yes
7.4 Has ethical clearance been obtained from your institution in case of
7.3? Yes
6
8.
LIST OF REFERENCES:
1. Kimball OP, Horan TN. The use of Dilantin in the treatment of
epilepsy. Ann Intern Med 1939; 13:787 -93.
2. Shapiro M. Acceleration of gingival wound he aling in non -epileptic
patients receiving diphenylhydantoin sodium. Exp Med Surg
1958; 16:41-53
3. Pendse AK, Sharma A, Sodani A, Hada S. Topical phenytoin in
wound healing. Int J Dermatol 1993; 32:214 -7.
4. Simpson GM, Kunz E, Slafta J. Use of diphenylhydantoin i n
treatment of leg ulcers. N Y State J Med 1965; 65:886 -8
5. Muthukumarasamy MG, Sivakumar G, Manoharan G. Topical
phenytoin in diabetic foot ulcers.Diabetes Care 1991; 14:909 -11.
6. Pai MRSM, Sitaram N, Kotian MS “Topical phenytoin in diabetic
ulcers: a double blind controlled trail” Indian J. Med Sci 2001:
55(11): 593 -9
7
Rhodes RS, Heyneman CA, Culbertson VL, Wilson SE, Phatak HM.
Topical phenytoin treatment of stage II decubitus ulcers
in the elderl y. Ann Pharmacother 200 1; 35:675-81.
7
9.
SIGNATURE OF THE
CANDIDATE:
10.
REMARK OF THE GUIDE:
11.
NAME AND DESIGNATION OF
(in block letters)
Satisfactory
DR.LEO FRANCIS TAURO
11.1 GUIDE :
ADDITIONAL PROFESSOR
DEPARTMENT OF SURGERY
FR.MULLER MEDICAL COLLEGE
KANKANADY,MANGALORE-575002
11.2 SIGNATURE :
11.3 CO-GUIDE:
DR.JACINTHA MARTIS
ASSOSS IATE PROFESSOR
DEPARTMENT OF DERMATOLOGY
FR.MULLER MEDICAL COLLEGE
KANKANADY,MANGALORE-575002
11.4 SIGNATURE:
11.5 HEAD OF THE
DEPARTMENT
DR.P.SATHYAMOORTHY AITHALA
PROFESSOR AND HOD
DEPARTMENT OF SURGERY
FATHER MULLER MEDICAL
COLLEGE, KANKANADY
MANGALORE-575002
11.6 SIGNATURE
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12.
12.1 REMARKS OF THE
CHAIRMAN AND DEAN
12.2 SIGNATURE
9