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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01680367
• Other study ID #: OSU-06043
• Secondary ID: NCI-2012-00985
• Status: Completed
• Phase: N/A
• First received: September 4, 2012
• Last updated: March 16, 2016
• Start date: November 2008
• Est. completion date: July 2010

Study information

• Verified date: March 2016
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Procedure:
• wound care management
Receive transparent film dressing or Xeroform petroleum gel impregnated gauze dressing
• wound care management
Receive native collagen wound dressing

Other:
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Inflammation as measured by the Wound Assessment Inventory (WAI)		Up to 14 days	No
Secondary	Categorical epithelialization assessment		Up to 14 days	No

External Links

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