Materials and Methods

STUDY DESIGN- Hospital based prospective non randomized uncontrolled

interventional study.
PLACE OF STUDY- Department of General Surgery & Department of Skin
and VD, SCB MCH, Cuttack
STUDY PERIOD- Nov 2018- Oct 2020
STUDY SUBJECT- Chronic ulcer patients admitted to General Surgery and
Skin & VD indoors of SCB MCH, Cuttack.
SAMPLE SIZE- 72 patients with 83 ulcers
SAMPLING METHOD- Written informed consent was obtained from all
patients. The study protocol, patient information sheet and consent form were
approved by the Institutional Ethics Committee.
Thorough history of the patient was taken before the procedure, which
included the following:

1. Name, age, sex, detailed address including contact number of the patient
or the number of the close attendant was collected.
2. Brief history regarding duration of development and course of the ulcer.
3. Occupational history, socio-economic status, personal history.
4. Treatment history including Multidrug Therapy.
5. Drug history-whether the patient is on any regular medication for any
6. chronic illness or is on corticosteroids or anticoagulant.

INCLUSION CRITERIA

1. Patients who have given written informed consent

2. Non-healing chronic ulcers >6 weeks duration.
3. Ulcer size 1x1 cm to 5x5 cm.
4. Patients in the age group 12-80 years.
5. Patients who have received conventional therapies for at least 6 weeks
with less than 60% improvement of ulcer.

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 Materials and Methods

6. Wound aetiologies include Hansen’s, Diabetic, Arterial, Venous or

Traumatic wound.

EXCLUSION CRITERIA

1. Patients with HIV & HBsAg antigen positivity.

2. Patient on corticosteroid medication.
3. Patients with history of bleeding disorders.
4. Patients with anticoagulant.
5. Ulcers with active infection.
6. Patients with uncontrolled diabetes.
7. Patients <12 years and >80 year.
8. Malignant ulcers.
9. Pregnant and lactating mothers.
10.Patients who did not give written consent.

Clinical examination:
All cases enrolled into the study were subjected to clinical examination
as follows.

1. General Examination including pulse, blood pressure and other vitals.

2. Systemic Examination detailed clinical examination of all systems were
done to rule out systemic co-morbidities.

Local examination:
Examination of the lesions with respect to their number, area, depth,
volume, margin, presence or absence of granulation tissue.

MEASUREMENT OF ULCER BY CLOCK-FACE METHOD:

Cotton-tipped applicators and disposable scales were used to measure
length, width and depth of the visible wound. Sussman described the way of

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 Materials and Methods

measuring ulcer by using clock-face method[139,140], in which length was 12:00 to

6:00 with 12:00 towards the head; width was 3:00 to 9:00 side by side.
Depth was taken from the deepest point of the wound bed to the level normal
skin surface.
Wound area was calculated using the formula for an eclipse [141]:
Length x width x 0.7854 (an ellipse in close to a wound shape than square or
triangle).
Volume was calculated using the formula: (length x width x 0.7854) x
depth.
Ulcer volume reduction was assessed based on reduction rate at the end
of 6th week.
Initial volume - final volume x 100
Initial volume

Laboratory investigations:

1. All patients were subjected to a host of investigations which included

2. Complete blood count (Hb%, DC, Total leukocyte count, total platelet
count)
3. FBS.
4. ELISA for HIV.
5. Test for HbsAg.
6. Bleeding time, Clotting time
7. Urine - routine and microscopic examination
8. Liver function tests
9. Renal function tests
10.Colour Doppler of lower limbs in venous ulcer cases

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 Materials and Methods

PREPARATION OF PLATELET-RICH FIBRIN MATRIX:

Under strict aseptic precautions, 10 ml of venous blood was drawn and
added to a sterile centrifugation tube devoid of anticoagulant. Centrifugation
was done at 3000 rpm for 10 minutes. Three layers were obtained: upper straw-
coloured platelet poor plasma (PPP), red-coloured lower fraction containing red
blood cells and the middle fraction containing platelet-rich fibrin matrix
(PRFM). The upper straw-coloured layer was discarded. PRFM was separated
from red corpuscles at the base using a sterile forceps and scissor, preserving a
small RBC layer measuring around one mm in length, which then transferred to
a sterile gauze. Middle membrane so obtained was compressed between two
gauze pieces gently and was applied on a healthy wound followed by
application of a secondary non-absorbable dressing. Adequate rest was advised
during the treatment course. The secondary dressing and the dried PRFM was
removed from the wound bed after a minimum of 5 days. The procedure was
repeated every week and the healing of the ulcer was assessed. Area and volume
were calculated and good photographs were taken.

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 Materials and Methods

FIGURE-1
INSTRUMENT REQUIRED FOR PREPARATION OF PRF

A C

B D

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 Materials and Methods

FIGURE-2

APPLICATION OF PRF

A C

B D

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