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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00985 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (control) | Experimental | Patients receive transparent film dressing (otolaryngology service) or Xeroform petroleum gel impregnated gauze dressing (surgical oncology service) after surgery. |
|
| Arm II (native collagen wound dressing) | Experimental | Patients receive native collagen wound dressing after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wound care management | Procedure | Receive transparent film dressing or Xeroform petroleum gel impregnated gauze dressing |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 14 days |
| Inflammation as measured by the Wound Assessment Inventory (WAI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Hofacre | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| wound care management | Procedure | Receive native collagen wound dressing |
|
| questionnaire administration | Other | Ancillary studies |
|
| Up to 14 days |
| Categorical epithelialization assessment | Up to 14 days |
| ID | Term |
|---|---|
| D010146 | Pain |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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