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

Not Applicable

Completed

• Conditions: Pain; Perioperative/Postoperative Complications
• Interventions: Procedure: wound care management; Other: questionnaire administration

• Registration Number: NCT01680367
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Submitted: 2012-09-04
• Study First Submitted QC: 2012-09-06
• Study First Posted: 2012-09-07
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-16
• Last Update Posted: 2016-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (native collagen wound dressing)	questionnaire administration	Patients receive native collagen wound dressing after surgery.
Arm II (native collagen wound dressing)	wound care management	Patients receive native collagen wound dressing after surgery.
Arm I (control)	wound care management	Patients receive transparent film dressing (otolaryngology service) or Xeroform petroleum gel impregnated gauze dressing (surgical oncology service) after surgery.
Arm I (control)	questionnaire administration	Patients receive transparent film dressing (otolaryngology service) or Xeroform petroleum gel impregnated gauze dressing (surgical oncology service) after surgery.

Primary Outcome Measures

Name	Time	Method
Pain score ranging in value from 0 to 10	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

Name	Time	Method
Inflammation as measured by the Wound Assessment Inventory (WAI)	Up to 14 days
Distress checklist score	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.
Categorical epithelialization assessment	Up to 14 days

Trial Locations

Locations (1)

The Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States