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

Primary Purpose

Pain, Perioperative/Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
wound care management
wound care management
questionnaire administration
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Ohio State University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (control)

Arm II (native collagen wound dressing)

Arm Description

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

Patients receive native collagen wound dressing after surgery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Inflammation as measured by the Wound Assessment Inventory (WAI)
Categorical epithelialization assessment

Full Information

First Posted
September 4, 2012
Last Updated
March 16, 2016
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01680367
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Perioperative/Postoperative Complications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (control)
Arm Type
Experimental
Arm Description
Patients receive transparent film dressing (otolaryngology service) or Xeroform petroleum gel impregnated gauze dressing (surgical oncology service) after surgery.
Arm Title
Arm II (native collagen wound dressing)
Arm Type
Experimental
Arm Description
Patients receive native collagen wound dressing after surgery.
Intervention Type
Procedure
Intervention Name(s)
wound care management
Intervention Description
Receive transparent film dressing or Xeroform petroleum gel impregnated gauze dressing
Intervention Type
Procedure
Intervention Name(s)
wound care management
Intervention Description
Receive native collagen wound dressing
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Pain score ranging in value from 0 to 10
Description
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.
Time Frame
Up to 14 days
Secondary Outcome Measure Information:
Title
Distress checklist score
Description
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.
Time Frame
Up to 14 days
Title
Inflammation as measured by the Wound Assessment Inventory (WAI)
Time Frame
Up to 14 days
Title
Categorical epithelialization assessment
Time Frame
Up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Hofacre
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.osu.edu
Description
The Jamesline

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

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