Ignite Creation Date:
2024-05-06 @ 1:19 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01770860
Status:
COMPLETED
Last Update Posted:
2014-08-04
First Post:
2013-01-16
Brief Title:
A Test of Different Kinds of Bandages on Healing of Wounds
Sponsor:
Johnson Johnson Consumer Products Company Division of Johnson Johnson Consumer Companies Inc
Organization:
Johnson Johnson Consumer and Personal Products Worldwide
Study Overview
Official Title:
An Assessment of QuiltVent Pad Technology on the Healing of Induced Dermabrasion Wounds
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This two-week study will compare the healing of minor wounds when no bandage is applied against four different types of bandages
The study investigators will make five small wounds similar to scrapes about a half-inch square on the back of subjects who qualify to participate in the trial and have given informed consent Four of the wounds will be covered by different bandages and one will be left uncovered Participants will visit the clinic every day for 2 weeks or until all the wounds are healed whichever comes first At the clinic the bandages will be removed the doctor will score the wounds a picture will be taken of the wounds and new bandages will be applied
It is expected that some pain and itching will be experienced because they are part of the normal wound healing process Subjects will be asked about adverse events at each visit and will have the opportunity to discuss issues or concerns with the investigator or the doctor during the course of the trial It is expected that the wounds will be completely healed within 14 days but if not the participant will need to return to the clinic for follow-up treatment until the wounds are completely healed
We will see if the different bandages help with the healing of the wounds during the study
The study investigators will make five small wounds similar to scrapes about a half-inch square on the back of subjects who qualify to participate in the trial and have given informed consent Four of the wounds will be covered by different bandages and one will be left uncovered Participants will visit the clinic every day for 2 weeks or until all the wounds are healed whichever comes first At the clinic the bandages will be removed the doctor will score the wounds a picture will be taken of the wounds and new bandages will be applied
It is expected that some pain and itching will be experienced because they are part of the normal wound healing process Subjects will be asked about adverse events at each visit and will have the opportunity to discuss issues or concerns with the investigator or the doctor during the course of the trial It is expected that the wounds will be completely healed within 14 days but if not the participant will need to return to the clinic for follow-up treatment until the wounds are completely healed
We will see if the different bandages help with the healing of the wounds during the study
Detailed Description:
This study is evaluating the performance of various bandages on facilitating the healing of induced dermabrasion wounds To qualify for this study subjects must meet the inclusionexclusion criteria within the protocol-specified parameters at both the screening and baseline visits Once a subject is qualified five dermabrasion wounds will be created on each subjects back by a licensed physician Four of the wounds will be covered with four different commercially-available bandages and one wound will be left open to the air to serve as a no treatment control Treatments and control will be randomized to application site During this 14-day clinical study subjects will return to the site for daily evaluations study bandages will also be replaced daily by study personnel Adverse events will be observed and collected by querying each subject at each visit and during any follow-up period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None