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

A Comparative Study of Dressings for Split-Thickness Skin Graft Donor Sites.

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.

Study Overview

• Status: Completed
• Conditions: Pain; Perioperative/Postoperative Complications
• Intervention / Treatment: Other: questionnaire administration; Procedure: wound care management; Procedure: wound care management

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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (control); Patients receive transparent film dressing (otolaryngology service) or Xeroform petroleum gel impregnated gauze dressing (surgical oncology service) after surgery.	Other: questionnaire administration; Ancillary studies; Procedure: wound care management; Receive transparent film dressing or Xeroform petroleum gel impregnated gauze dressing; Procedure: wound care management; Receive native collagen wound dressing
Experimental: Arm II (native collagen wound dressing); Patients receive native collagen wound dressing after surgery.	Other: questionnaire administration; Ancillary studies; Procedure: wound care management; Receive transparent film dressing or Xeroform petroleum gel impregnated gauze dressing; Procedure: wound care management; Receive native collagen wound dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 14 days
Inflammation as measured by the Wound Assessment Inventory (WAI)		Up to 14 days
Categorical epithelialization assessment		Up to 14 days

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Robert Hofacre, Ohio State University

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: September 4, 2012
• First Submitted That Met QC Criteria: September 6, 2012
• First Posted (Estimate): September 7, 2012

Study Record Updates

• Last Update Posted (Estimate): March 18, 2016
• Last Update Submitted That Met QC Criteria: March 16, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: OSU-06043; NCI-2012-00985 (Registry Identifier: CTRP (Clinical Trial Reporting Program))