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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Ohio State University Comprehensive Cancer Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Robert Hofacre, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01680367
First received: September 4, 2012
Last updated: September 6, 2012
Last verified: September 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Categorical epithelialization assessment [ Time Frame: Up to 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: November 2008
Estimated Primary Completion Date: December 2012 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680367

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

Additional Information:
No publications provided

Responsible Party: Robert Hofacre, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01680367     History of Changes
Other Study ID Numbers: OSU-06043, NCI-2012-00985
Study First Received: September 4, 2012
Last Updated: September 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014