RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES,
Banglore,Karnataka.
Annexure - II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
(to be submitted in duplicate)
1.Name of the candidate and addressDr.Vijay Pandey
Permanent Address S/o Sri.J.P. Pandey
D-5,Nirala Nagar,
Lucknow.(U.P.)– 226020
Correspondence AddressDept. of Surgery
M.S.RamaiahMedicalCollege and Teaching Hospital, Bangalore-560054
2. Name of InstitutionM.S.RamaiahMedicalCollege and Teaching Hospital, Bangalore
3. Course of Study and subjectM.S. General Surgery
4. Date of Admission to the course07-June-2007
5. Title of TopicCOMPARATIVE STUDY OF COLLAGENASE AND PAPAIN-UREA FOR ULCER DEBRIDEMENT
6. BRIEF RESUME OF INTENDED WORK :
6.1NEED FOR WORK –
Management of wounds though common in surgical wards, there needs to be thorough knowledge about pathophysiology & various modes of treatment options available which form corner stone in treating such patients. It helps the treating surgeon to achieve better outcome both in terms of patient compliance& reducing time, cost.
It has been demonstrated that that devitalized tissue present in chronic ulcers enhances bacterial growth, reduces resistance to infection and impedes re-epithelialization.1
In this context,the present study would ascertain the benefits of using collegenase vs papain urea in the management of ulcer.
6.2 REVIEW OF LITERATURE:
Chronic wounds do not follow the same orderly and timely progression toward healing as acute wounds.2Various local and systemic factors such as desiccation, pressure, infection, necrotic tissue, age, nutritional status, and co-morbid diseases can impede healing.3 Steps may be taken, however, to promote wound healing. Known as wound bed preparation, this multistep process can be defined as “the global management of the wound to acceslerate endogenous healing or to facilitate the effectiveness of other therapeutic measure.2” Wound bed preparation involves decreasing the bacterial load, managing exudate, and removing necrotic orfibrous tissue.
Debridement, a critical component of any plan to prepare the chronic wound bed for healing, addresses the necrotic burden of a wound.4
TYPES OF DEBRIDEMENT: The clinician can choose amongst the severaloptions for debridement. These are surgical/sharp,mechanical, autolytic, enzymatic, and biologic.4This study will focus on enzymatic debridement.
Enzymatic debridement uses topical enzymes to removenecrotic tissue by digesting and dissolving the devitalized tissuein the wound bed. Some enzymes are selective and recognize only devitalized tissue.1
Two enzymatic debriding agents are currently available. One preparation contains papain and urea in acream base; the other is composed of collagenase in a petroleumbase. The papain-urea combination also comes in a formulationwith chlorophyllin-copper complex.
Papain is a proteolytic enzyme derived from the fruit ofCarica papaya. It is a nonspecific cysteine protease, capable ofbreaking down a variety of necrotic tissue substrates.5Urea’srole is to facilitate papain’s proteolytic action by altering the structure of proteins.
Collagenase, derived from Clostridium histolyticum, has optimalenzymatic activity in a pH range of 6 to 8. This correspondsto the pH range typically found in human wounds. Collagenase is a water soluble proteinase that specifically attacks and breaks down collagen.6 One enzyme (collagenase) has once-a-day application; the other (papain-urea) may need once or twice-a-day application.Collagenase enzymaticdebriding agents maydigest necrotic tissuefrom the bottom-up;papain-urea preparations,from the top-down.7
The goal of debridement is to remove necrotic debrisand fibrous tissue, an important facet of wound bed preparation. Debridement can removesenescent cells that may impede wound healing. Using analgorithm or chart, can help the clinician make sound decisions regarding whichdebridement method (or methods) to use for which wound.
6.3 AIM OF THE STUDY:
To compare the effectiveness of collagenase and papain-urea for ulcer debridement.
6.4 OBJECTIVES OF STUDY :
- To compare effectiveness of collagenase v/s papain-urea in ulcer debridement.
- Their role in promoting ulcer healing by granulation and reduction in ulcer size.
7. MATERIALS AND METHODS
7.1SOURCE OF DATA:
Total of 50 patients with chronic ulcer who would present to M.S.RAMAIAHMEDICALHOSPITAL, BANGALORE from september 2007 to august 2009. Patients would be selected , randomised and divided into two groups using appropriate stastistical methods. Group1- 25 patients treated with collagenase,group 2 - 25 patientstreated with papain-urea.
7.2METHODS OF COLLECTION OF DATA :
A clinical assessment/evaluation would be undertaken to diagnose the ulcers.
- Wound and devitalized tissue assessed and measurements taken
- Wound cleaned with normal saline,daily dressing done for a week.
- No other topical agent used
Treatment phase
- Patients would be randomized when the ulcer and area with slough were stable(<20%change in size) or improving(decreasing in size)
- Patients would be evaluated at 1,2,3 and 4weeks.Reduction of nonviable tissue by clinical evaluation.
- Degree of granulation tissue and reduction in ulcer size noted. Discharge,odour,induration etc noted for overall wound response to treatement.
- Dressings would be done using same technique – cleaning with saline application of ointment(collegenase/papain-urea) and putting adressing.
7.3Inclusion criteria
- Chronic ulcers with slough
- Superficial or deep ulcers
- Wounds for which debridement is required for healing.
7.4Exclusion criteria
- Presence of severe infection,cellulites or uncontrolled diabeties
- Conditions which impair wound healing as renal ,hepatic ,hematologic diseases etc.
- Patients on steroids , immunosupprisive agents, radiation or chemotherapy.
7.5 Does this study require any investigation or intervention to be conducted on patients or other humans or animals? If so, describe briefly.
Investigations required:CBC, RFT, LFT, RBS, CULTURE SENSITIVITY, X-RAY OF THE INVOLVED PART
- No animals will be used in the study
- The treatment is the routine line of management in terms of debridement.
STUDY DESIGN :
Prospective , randomized, non-concurrent, comparative study.
STATISTICAL ANALYSIS :
The study data were analysed using:
- student–t test to test the stastical significance of the difference between collegenase and papain-urea for wound debridement.
- Chi Square test for testingstatistical differences in baseline characters of the study population.
7.6 Has ethical clearance been obtained from your institution?
Yes, the certificate of the same is enclosed.
8. LIST OF REFERENCES –
1-Oscar M.Aivarez , A Prospective and Randomised,Comparative Study of Collagenase and Papain-urea for Pressure Ulcer Debridement. Wounds 2000,12(2);15-25
2-Falanga V.- Wound bed preparation and role of enzymes:a case for multiple actions of the therapeutic agents.Wounds 2002;14:47-57
3-F.Charles Brunicardi,et al. Schwartz Prininciples of surgery , 8th edition , Wound healing , 8/235
4-Elizabeth A.Ayello ,Debridement:Controlling the necrotic/cellular burden.Adv Skin Wound Care 17;2:66-78
5-Wright J.B. Accuzyme papain-urea debridement ointment,a historical review.Wounds 2003;15(supplement)2S-12S
6-Krieg t. Collagen in the healing wounds. Wounds 1995;7(supplement) 5A-12A
7-Hebda P.A. Biochemistry of wound healing:The effects of active ingredients of standard debriding agents - papain and collagenase – on digestion native and denatured collagenous substances,fibrin,elastin. Wounds 2001;13:190-4
9.Signature of Candidate:
10.Remarks of the guide: It is a very good study, going to be helpful for management of ulcer patients
11.1Name and Designation ofDr.H.M.Vijay Kumar
the guideM.S.
Associate Professor
Dept. of Surgery
MS Ramaiah Medical College
11.2 Signature
11.3 Head of DepartmentDr. M.R.Sreevathsa
M.S.
Professor and Head
Dept. of Surgery
MS Ramaiah Medical College
11.4 Signature
12.1 Remarks of Chairman and Principal
12.2 Signature