This study is to determine what dressing would work best to heal and keep from hurting, the split-thickness skin graft donor site which will be done as part of the patient's surgical procedure. Currently there is a dressing that is transparent and it is placed on the wound after surgery and wrapped with gauze and an elastic bandage. Two days after the surgery the gauze and elastic bandages are removed and the area is left with the transparent dressing. Sometimes the dressing needs to be changed because it leaks. On the fifth day this dressing is removed and the wound is left open to air. The dressing researchers are studying is a dressing that has been used for different types of wounds, as well as this type of wound. It is applied in the same manner; however, it is left in place until it falls off independently, usually around post-operative (post-op) day 10.
PRIMARY OBJECTIVES: I. Which dressing type and technique is most effective in minimizing pain and inflammation and promoting epithelialization in patients who have had surgery which requires the use of an anterior thigh split-thickness skin graft? OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive transparent film dressing (otolaryngology service) or Xeroform petroleum gel impregnated gauze dressing (surgical oncology service) after surgery. ARM II: Patients receive native collagen wound dressing after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
69
Receive transparent film dressing or Xeroform petroleum gel impregnated gauze dressing
Receive native collagen wound dressing
Ancillary studies
The Ohio State University Medical Center
Columbus, Ohio, United States
Pain score ranging in value from 0 to 10
Initial analyses will include two sample t-tests (or a nonparametric equivalent, if more appropriate) for each day to compare the mean pain scores for each treatment group. The pain score will be evaluated using multiple linear regression, while multiple logistic or polytomous regression will be used for the categorical outcomes.
Time frame: Up to 14 days
Distress checklist score
The specific modeling approach for the distress score will depend on the range of values obtained. Standard model building techniques will be employed and clinically important interactions between covariates and the groups will be explored.
Time frame: Up to 14 days
Inflammation as measured by the Wound Assessment Inventory (WAI)
Time frame: Up to 14 days
Categorical epithelialization assessment
Time frame: Up to 14 days
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