Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.