Pain, Perioperative/Postoperative Complications
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREwound care management
Receive transparent film dressing or Xeroform petroleum gel impregnated gauze dressing
OTHERquestionnaire administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Population of otolaryngological or surgical oncology patients experiencing an autologous split-thickness skin graft as part of their surgical procedure * Patients will have a Glasgow Coma score of 15 (or 10 with a tracheostomy) * Patient donor sites will be limited to the anterior thigh * Patients will be free of documented circulatory deficits, neuropathy, or mental illness which prohibits their ability to independently consent or respond to questions regarding pain * Patients will be able to give consent independently * Patients will be able to read and write in English
Exclusion criteria
* Patients unable to give independent consent for any reason * Skin graft donor sites other than the anterior thigh * Patients with a concurrent diagnosis of diabetes, peripheral vascular disease, and/or paresthesias or paralysis of the lower extremities * Patients who are unable to complete a self-report pain scale * Patients who are prisoners * Patients who are known active alcoholics * Patients on steroids or other medications known to affect healing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score ranging in value from 0 to 10 | Up to 14 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distress checklist score | Up to 14 days | 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. |
| Inflammation as measured by the Wound Assessment Inventory (WAI) | Up to 14 days | — |
| Categorical epithelialization assessment | Up to 14 days | — |
Countries
United States
Outcome results
None listed