Clinical trial NCT01680367: Wound Dressings For Split-Thickness Skin Graft Donor Sites in Patients Undergoing Surgery
Official title: A Comparative Study of Dressings for Split-Thickness Skin Graft Donor Sites.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Perioperative/Postoperative Complications
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain score ranging in value from 0 to 10
timeFrame: Up to 14 days
Secondary outcomes:
measure: Distress checklist score
timeFrame: Up to 14 days
measure: Inflammation as measured by the Wound Assessment Inventory (WAI)
timeFrame: Up to 14 days
measure: Categorical epithelialization assessment
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Robert Hofacre
role: PRINCIPAL_INVESTIGATOR
References: