Wound Dressings For Split-Thickness Skin Graft Donor Sites in Patients Undergoing Surgery

The Ohio State University

Status

Completed

Conditions

Perioperative/Postoperative Complications

Pain

Treatments

Other: questionnaire administration

Procedure: wound care management

Study type

Interventional

Funder types

Other

Identifiers

NCT01680367

OSU-06043

NCI-2012-00985 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

69 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

69 participants in 2 patient groups

Arm I (control)

Experimental group

Description:

Patients receive transparent film dressing (otolaryngology service) or Xeroform petroleum gel impregnated gauze dressing (surgical oncology service) after surgery.

Treatment:

Procedure: wound care management

Other: questionnaire administration

Arm II (native collagen wound dressing)

Experimental group

Description:

Patients receive native collagen wound dressing after surgery.

Treatment:

Procedure: wound care management

Other: questionnaire administration