CTRI Number |
CTRI/2020/02/023207 [Registered on: 10/02/2020] Trial Registered Prospectively |
Last Modified On: |
04/02/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Study to compare Collagen sheet dressing with Vaseline gauze dressing when used as a dressing material in sites from where skin graft is taken |
Scientific Title of Study
|
A randomized control trial comparing collagen sheet dressing with vaseline gauze dressing in assesing pain in split thickness skin graft donor site |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Chiran Bhakta Bista |
Designation |
Resident , General Surgery |
Affiliation |
Armed Forces Medical College, Pune |
Address |
Department of surgery,
Armed Forces Medical College,
Wanowrie, Solapur road, near race course
Pune MAHARASHTRA 411040 India |
Phone |
8484866623 |
Fax |
|
Email |
cbista@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
S Tripathy |
Designation |
Associate Professor, Senior Advisor General Surgery |
Affiliation |
Armed Forces Medical College, Pune |
Address |
Department of surgery,
Armed Forces Medical College,
Wanowrie, Solapur road, near race course
Pune MAHARASHTRA 411040 India |
Phone |
9623198357 |
Fax |
|
Email |
dr.stripathy@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Chiran Bhakta Bista |
Designation |
Resident, General Surgery |
Affiliation |
Armed Forces Medical College,Pune |
Address |
Department of surgery,
Armed Forces Medical College,
Wanowrie, Solapur road, near race course
Pune MAHARASHTRA 411040 India |
Phone |
8484866623 |
Fax |
|
Email |
cbista@gmail.com |
|
Source of Monetary or Material Support
|
Armed Forces Medical College, Wanowrie, Solapur road, Pune,411040, Maharastra |
|
Primary Sponsor
|
Name |
Armed Forces Medical College |
Address |
Department of surgery,
Armed Forces Medical College,
Wanowrie, Solapur road, near race course,
Pune |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Chiran Bhakta Bista |
Armed Forces Medical College |
Armed Forces Medical College,Surgical Division,Department of Surgery,
Wanowrie, near race course Pune MAHARASHTRA |
8484866623
cbista@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethical committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: L768||Other intraoperative and postprocedural complications of skin and subcutaneous tissue, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Collagen sheet dressing |
Collagen sheet is a biological dressing derived from bovine source, comprising mostly type I and type III collagen which is retained in the tissue and gradually absorbed.It is also widely used in management of split thickness skin graft donor site wounds as a dressing material |
Comparator Agent |
Vaseline gauze dressing |
Vaseline gauze is a sterile, occlusive dressing consisting of fine mesh, absorbent gauze impregnated with approximately three times its weight of white petrolatum. It is widely used in management of burn wounds and split thickness skin graft donor site wounds. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
90.00 Year(s) |
Gender |
Both |
Details |
All patients who undergo split thickness skin graft surgery for any indication of the disease and can give consent on their own will be included |
|
ExclusionCriteria |
Details |
1. Immunocompromised patients under cytotoxic drugs or steroids
2. Any scar at donor site |
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare collagen sheet dressing and vaseline gauze dressing in assesing pain based on numerical pain rating scale on post operative days 01,07,14 and 21 |
days 01,07,14 and 21 |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare days required for epithelialization with use of each dressing |
Not applicable |
To compare the presence of surgical site infection with use of each dressing |
Till the wound is completely healed and patient is under follow up |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
10/02/2020 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Split
thickness skin grafting is a common reconstructive technique for the treatment
of patients with deep burns and other traumatic injuries. Various types of
dressing materials are available for the management of donor site after
harvesting a split thickness skin graft such as semi permeable film dressings,
semi permeable foam dressings, hydrogels, hydrocolloids, alginate dressings,
bioactive wound dressings such as collagen, hyaluronic acid, chitosan and
elastin or tissue engineered, medicated and composite dressings. Selection of
an ideal dressing in such vast variety is a challenge. Thus, this study is
aimed at most common presentation of the patient which is pain as primary
outcome and similarly surgical site infection and time of epithelialization as secondary
outcomes.
Vaseline gauze is a sterile, occlusive dressing consisting of fine
mesh, absorbent gauze impregnated with approximately three times its weight of
white petrolatum.
Collagen sheet is a biological dressing derived from bovine
source, comprising mostly type I and type III collagen which is retained in the
tissue and gradually absorbed.
Both dressings are commonly used and there is no ethical issue
associated with their usage.
The primary objective of my study is to compare severity of pain
with use of each dressing based on numerical pain rating scale where patient
will rate the severity of his/her pain out of 10 (10 being most severe) on post-operative
days 01, 07, 14 and 21. I have considered pain as primary objective because
that is what the patient is most considered about. Similarly, my secondary
objectives are to compare the number of days for epithelialization which is the
number of days required for healing of the wound and presence or absence of
surgical site infection. Thus, the study will also compare and analyze with
usage of which dressing material the wound will heal faster and in which group
surgical site infection is common.
|