Skip to main content
OpenTrials
Completed

NCT Number: NCT01680367

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wound care management

Procedure

Receive transparent film dressing or Xeroform petroleum gel impregnated gauze dressing

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Pain score ranging in value from 0 to 10

    Time frame: 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 outcomes

  1. Distress checklist score

    Time frame: 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.

  2. Inflammation as measured by the Wound Assessment Inventory (WAI)

    Time frame: Up to 14 days

  3. Categorical epithelialization assessment

    Time frame: Up to 14 days

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 7, 2012
Registry last updated
Mar 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.