A study to compare and determine the pain relieving property of two types of dressings- collagen(a type of biological product from cattle intestines) and vaseline coated sterile gauze, on the area from which skin grafts are harvested for various conditions.
- Conditions
- Exposure to flames in uncontrolledfire in building or structure,
- Registration Number
- CTRI/2020/07/026484
- Lead Sponsor
- Col venkatnarayanan
- Brief Summary
Split thickness skin grafting is a common reconstructive procedure for the treatment of patients with superficial skin defects. 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. This study attempts to assess the pain relief at the donor site provided by two of the most commonly used dressings- collagen sheet and Vaseline gauze.
SPLIT THICKNESS SKIN GRAFT:
A skin graft is a segment of dermis and epidermis that is separated from its blood supply and donor site and transplanted to another recipient site on the body. It is classified as thick, intermediate and thin split thickness grafts based on the thickness of the dermis incorporated into the graft. It may be harvested with a power dermatome that can be adjusted for width and depth to cut uniformly thick grafts usually in strips of 0.006 to 0.024 inches in thickness, or manually by using a Humby’s knife. The STSG can be meshed by cutting slits into the sheet of graft and expanding it usually in a 1:1.5 or 1:2 ratio. An STSG can be taken from anywhere in the body; donor site considerations include color, texture, thickness, amount of skin required and scar visibility.
The donor site wound is often painful due to exposed nerve ending in the residual dermis and also has exudates from the raw area, till it epithelises. If wound exudate is not contained by the dressing it is prone to infection. An optimal donor site dressing should have following qualities:
It should maintain a moist environment and support rapid healing without adhering to the wound bed. It needs to be absorbent and easy to apply and remove.
There should be pain free dressing changes and should be cost effective.
Study Protocol:
1)All cases undergoing split thickness skin graft at this tertiary care hospital will be considered.
2)Patients will be operated as per standard protocol and dressing will be chosen from either the test or the control group as per prevailing surgical protocol and choice of surgeon.
3)Informed written consent for participation in the study will be taken at the time of admission in the hospital.
4)Proforma for collection of data including personal particulars, history & other relevant variables will be filled.
5)Numerical Pain Rating (NPR) Score will be calculated after 24 hours post-operativley and after administering 3 doses of appropriate analgesic.
6)Days taken for re-epithelisation of donor site will be assessed based on time taken for the dressing to separate from the donor site. Separation of dressing occurring after 28 days from the day of surgery will be taken as delayed healing of donor site.
Statistical analysis: All data will be tabulated and appropriate statistical tests will be used.
Ethical considerations:
1)Written informed consent of the participants will be taken as per proforma.
2)No ethical issues foreseen as no new intervention or dressing material are being used.
Implications:
The results will be used to determine which of the two commonly used dressing materials- collagen sheet or vaseline gauze is more effective in reducing pain at split skin thickness skin graft donor site. This study will also attempt to identify those factors that may play a role in causing delayed re-epithelization of the skin graft donor site, thereby leading to better care and faster healing of these patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 20
All adults undergoing split thickness skin graft harvest for any indication.
Immunocompromised patients Any scar at donor site.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the pain score based on Numerical Pain Rating (NPR) scale in both the groups. After 24 hours of surgery and administration of 3 doses of appropriate analgesic
- Secondary Outcome Measures
Name Time Method To identify the factors influencing delayed healing of split thickness skin graft donor site. Separation of dressing occurring after 28 days from the day of surgery will be taken as delayed healing of donor site.
Trial Locations
- Locations (1)
Command Hospital
🇮🇳Pune, MAHARASHTRA, India
Command Hospital🇮🇳Pune, MAHARASHTRA, IndiaCol VenkatnarayananPrincipal investigator7263957159rvenkatnacad@gmail.com