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 . SHALINI G. HEGDE
POST GRADUATE STUDENT
DEPARTMENT OF SURGERY
KIMS, HUBLI
2. / Name of the Institution / KARNATAKA INSTITUTE OF MEDICAL SCIENCES,
HUBLI, KARNATAKA STATE, INDIA 580 022
3. / Course of study and subject / M.S ( GENERAL SURGERY)
4. / Dateof admission to course / 10/05/10
5. / Title of the Topic / EFFICACY OF AUTOLOGOUS PLATELET GEL
VERSUS REGULAR DRESSING IN EPITHELIALIZATION AND WOUND REDUCTION IN CHRONIC WOUNDS
6. / Brief resume of the intended work:
6.1 Need for study:
Chronic wounds are a frequent problem in developing countries and represent a heavy burden to both the patient and the service provider. They are often difficult to heal because they lack the necessary growth factors to maintain the healing process, and are frequently complicated by superinfection.
Platelets are known to release certain factors from α granules which include Platelet Derived Growth Factor (PDGF) and Epidermal Growth Factor (EGF), which act locally on the wound and hasten the healing process. Platelet extract has been used in trials on chronic wounds and has shown impressive results in both healing percentage and time for epithelialization.
Since not all patients can afford commercially available recombinant platelet gel for dressing, platelet extract from the patient’s own blood has been used in trials on chronic wounds.
Hence, this study intends to demonstrate the therapeutic role of autologous platelet gel in epithelialization and wound reduction of chronic wounds.
6.2 Review of the literature:
Knighton DR et a1l in a prospectively randomized, blinded trial of a total of 32 patients with chronic wounds of the lower extremity demonstrated a highly statistically significant effect of topically applied platelet-derived growth factors on the repair of chronic,nonhealing, cutaneous ulcers.
Eppley BL et al2 quantified platelet number and growth factors released from a prepared platelet concentrate. The study detected a variety of potentially therapeutic growth factors in significant levels in platelet-rich plasma preparations and concluded that sufficient concentrates of these growth factors through platelet gels may expedite wound healing.
Steed DL et al3 evaluated the use of recombinant human platelet derived growth factor (PDGF) for the treatment of 922 patients with diabetic neuropathic ulcers. The analysis showed that patients treated with PDGF had significant increase in complete healing as compared to patients given placebo.
Autologous Platelet Rich Plasma has been found to be safe and have enhanced soft tissue healing with increased rate of bone formation. This property has been studied by Vivek GK et al4, in the osseous regeneration of third molar socket. The study shows faster regeneration in the cases treated with platelet rich plasma as compared to the control group
Robert G. Frykberg et al5 used autologous platelet-rich plasma (PRP) gel on 49 patients with chronic, nonhealing wounds and found that 97% of wounds improved, for all wound etiologies. The results of this study suggest the application of PRP gel can reverse nonhealing trends in chronic wounds.
6.3Aims and Objectives of the study:
To test the efficacy of autologous platelet gel in epithelialization and wound reduction in chronic wounds in comparison to conventional method of treatment
7. / Materials and Methods:
7.1 Source of data: Patients admitted as inpatients or attending the outpatient on a regular basis for the management of chronic wounds in the Department of Surgery, KIMS, Hubli
7.2 Methods of collection of data:
  • Details of cases will be recorded including history and wound characteristics
  • Routine investigations
  • Follow up with size of wound after 4 dressings
Duration of the study: 1 year (January 2011 to December 2011).
Type of study: Prospective, time bound study
Sample size:30
Inclusion criteria:
  • Age group 25 – 70 years
  • Ulcer ≥ 4 weeks duration
  • Ulcer ≤ 10 cm2 in size
  • Hb ≥ 10 g%
  • FBS ≤ 110 mg% and PPBS ≤ 140 mg% if diabetic
Exclusion criteria: Ulcers with evidence of malignancy, active pus discharge, slough
Statistical Methods: Unpaired students ‘t’ test and chi square tests
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).
  • Routine blood investigations
  • Patient’s own blood is used to prepare platelet gel, which is used for wound dressing
7.4 Has ethical clearance been obtained from ethical committee of your institution in case of 7.3?
YES. Clearance from the Ethical committee of KIMS, Hubli is obtained.
8. / List of References:
  1. Knighton DR, Ciresi K, Fiegel VD, Schumerth S, Butler E, Cerra F. Stimulation of repair in chronic, non healing cutaneous ulcers using platelet derived wound healing formula. Surg Gynecol Obstet 1990, Jan 170(1): 56-60
  2. Eppley BL, Woodel JE, Higgins J. Platelet quantification and growth factor analysis for platelet rich plasma: Implications for wound healing. Plast Reconst Surg 2004 Nov; 114(6): 1502-8
  3. Steed DL. Clinical evaluation of recombinant human platelet-derived growth factor for the treatment of lower extremity ulcers. Plast Reconstr Surg 2006 Jun; 117 (7 Suppl): 143S-149S; discussion 150S-151S
  1. Vivek GK, Sripathi Rao BH et al. Potential for osseous regeneration of platelet rich plasma: a comparative study in mandibular third molar sockets. J Maxillofac Oral Surg 2009 8(4): 308 - 311
  1. Robert G. Frykberg, Vickie R. Driver, Donna Carmen. Chronic wounds treated with a physiologically relevant concentration of Platelet rich plasma gel: A prospective case series. Ostomy Wound Management 2010; 56(6):36-4

9. / Signature of the candidate
10. / Remarks of the guide
11. / Name and Designation
11.1 Guide / DR. b.s. madakatti
professor and hod
department of general surgery
kims,hubli
11.2 Signature
11.3 Co-Guide
11.4 Signature
11.5 Head of Department / DR. b.s. madakatti
professor and hod
department of general surgery
kims, hubli
11.6 Signature
12. / 12.1 Remarks of the Principal and Chairman
12.2 Signature