PainNCT01680367
Wound Dressings For Split-Thickness Skin Graft Donor Sites in Patients Undergoing Surgery
A study testing wound care management and questionnaire administration in people with Pain and Perioperative/Postoperative Complications, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Perioperative/Postoperative Complications
- What is being tested?
- wound care management and questionnaire administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Pain, Perioperative/Postoperative Complications
- Being tested
- wound care management, questionnaire administration
- Medical subject headings
- Pain, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wound care managementProcedure or surgery
Receive transparent film dressing or Xeroform petroleum gel impregnated gauze dressing
wound care managementProcedure or surgery
Receive native collagen wound dressing
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (control) | Experimental | Patients receive transparent film dressing (otolaryngology service) or Xeroform petroleum gel impregnated gauze dressing (surgical oncology service) after surgery. Receives: Procedure: wound care management; Other: questionnaire administration |
| Arm II (native collagen wound dressing) | Experimental | Patients receive native collagen wound dressing after surgery. Receives: Procedure: wound care management; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 14 days
Secondary outcomes (3)
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.
Measured: Up to 14 days
Inflammation as measured by the Wound Assessment Inventory (WAI)
Measured: Up to 14 days
Categorical epithelialization assessment
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startNov 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Hofacre, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680367
- Sponsor's protocol ID
- OSU-06043
- Other IDs
- NCI-2012-00985
- Status last verified
- Mar 2016
- First submitted
- 4 Sep 2012
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Dressings for Split-Thickness Skin Graft Donor Sites.
- ClinicalTrials.gov ID
- NCT01680367
- Acronym / sponsor ID
- OSU-06043
- Conditions
- Pain, Perioperative/Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (control) | Experimental | Procedure: wound care management, Other: questionnaire administrationPatients receive transparent film dressing (otolaryngology service) or Xeroform petroleum gel impregnated gauze dressing (surgical oncology service) after surgery. |
| Arm II (native collagen wound dressing) | Experimental | Procedure: wound care management, Other: questionnaire administrationPatients receive native collagen wound dressing after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wound care managementReceive transparent film dressing or Xeroform petroleum gel impregnated gauze dressing | Procedure or surgery | Arm I (control) |
| wound care managementReceive native collagen wound dressing | Procedure or surgery | Arm II (native collagen wound dressing) |
| questionnaire administrationAncillary studies | Other | Arm I (control), Arm II (native collagen wound dressing) |
Primary outcome
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.
3 secondary outcomes
Distress checklist score
Time frame: Up to 14 days
Inflammation as measured by the Wound Assessment Inventory (WAI)
Time frame: Up to 14 days
Categorical epithelialization assessment
Time frame: Up to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
- The JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Hofacre principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wound care management and questionnaire administration in people with Pain and Perioperative/Postoperative Complications, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score ranging in value from 0 to 10 (time frame: Up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2016.