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

NCT01680367 | Completed DMC

• 2 other identifiers: OSU-06043NCI-2012-00985
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Perioperative/Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Distress checklist score

  Up to 14 days

• Inflammation as measured by the Wound Assessment Inventory (WAI)

  Up to 14 days

• Categorical epithelialization assessment

  Up to 14 days

Study Arms (2)

Arm I (control)

EXPERIMENTAL

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

Procedure: wound care management; Other: questionnaire administration

Arm II (native collagen wound dressing)

EXPERIMENTAL

Patients receive native collagen wound dressing after surgery.

Procedure: wound care management; Other: questionnaire administration

Interventions

wound care management PROCEDURE

Receive transparent film dressing or Xeroform petroleum gel impregnated gauze dressing

Arm I (control)

questionnaire administration OTHER

Ancillary studies

Arm I (control); Arm II (native collagen wound dressing)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Pain; Postoperative Complications

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Robert Hofacre

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: September 7, 2012
• Study Start: November 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 18, 2016

Record last verified: 2016-03

Locations

US (1)