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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01680367
First Posted: September 7, 2012
Last Update Posted: March 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center
  Purpose
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.

Condition Intervention
Pain Perioperative/Postoperative Complications Procedure: wound care management Other: questionnaire administration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Comparative Study of Dressings for Split-Thickness Skin Graft Donor Sites.

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Pain score ranging in value from 0 to 10 [ Time Frame: 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 Outcome Measures:
  • Distress checklist score [ Time Frame: 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) [ Time Frame: Up to 14 days ]
  • Categorical epithelialization assessment [ Time Frame: Up to 14 days ]

Enrollment: 69
Study Start Date: November 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (control)
Patients receive transparent film dressing (otolaryngology service) or Xeroform petroleum gel impregnated gauze dressing (surgical oncology service) after surgery.
Procedure: wound care management
Receive transparent film dressing or Xeroform petroleum gel impregnated gauze dressing
Other: questionnaire administration
Ancillary studies
Experimental: Arm II (native collagen wound dressing)
Patients receive native collagen wound dressing after surgery.
Procedure: wound care management
Receive native collagen wound dressing
Other: questionnaire administration
Ancillary studies

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680367


Locations
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Robert Hofacre Ohio State University
  More Information

Additional Information:
Responsible Party: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01680367     History of Changes
Other Study ID Numbers: OSU-06043
NCI-2012-00985 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: September 4, 2012
First Posted: September 7, 2012
Last Update Posted: March 18, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes