Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00007280
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2000-12-16
Brief Title:
Bioengineered Skin and Wound Healing
Sponsor:
Roger Williams Medical Center
Organization:
Roger Williams Medical Center
Study Overview
Official Title:
Mechanisms of Bioengineered Skin in Human Wounds
Status:
COMPLETED
Status Verified Date:
2008-04
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 study will look at whether a graft of bioengineered skin BSC known commercially as Apligraf stimulates the healing process in a persons own skin at the edge of a wound known as the edge effect The information from this study will provide a better understanding of the ways that grafts of bioengineered skin help the healing of chronic wounds
We will assign study participants to either the bioengineered skin group or the control group People in the control group will receive compression therapy with a multilayered compression bandage We will examine each participant before starting treatment and then once a week for 24 weeks or until the wound heals On the first day of treatment day 0 and at week 3 week 6 and week 24 end of treatment we will take a small tissue sample from the wound for a biopsy After the wound is completely healed we will ask the patient to return once a month for 6 months to make sure the wound stays healed
We will assign study participants to either the bioengineered skin group or the control group People in the control group will receive compression therapy with a multilayered compression bandage We will examine each participant before starting treatment and then once a week for 24 weeks or until the wound heals On the first day of treatment day 0 and at week 3 week 6 and week 24 end of treatment we will take a small tissue sample from the wound for a biopsy After the wound is completely healed we will ask the patient to return once a month for 6 months to make sure the wound stays healed
Detailed Description:
BSC is a two-layered sheet made from purified beef tendon collagen living human cells and a substance that maintains the cells until they are grafted removed We will obtain human cells from donors unrelated to the patient The human cells have been tested for the presence of infectious agents and found to be free of disease-causing organisms such as hepatitis virus the AIDS virus bacteria and fungi
We will randomly assign randomize study participants to either the bioengineered skin group or control group compression therapy with a multilayered compression bandage Regardless of the group to which a patient is assigned we expect participation in this study for 12 months following the start of study treatment We will examine each patient at the screening visit 2 weeks before randomization and then again 3-4 days before the start of treatment to make sure the wound is free of any signs of infection After the initial randomization visit we will examine the wound once a week for 24 weeks or until the wound heals whichever is earlier As soon as we have determined that the wound is completely healed we will ask the patient to return once a month for 6 months to make sure it remains healed
Bioengineered skin group We will apply BSC to the wound and cover it with xeroform dressing foam bolster gauze dressing and compression bandage If we do not note any improvement at the week 6 visit we will apply BSC on the wound a second time
Control group We will place a multilayered compression bandage on the wound of participants assigned to this group
Biopsies small piece of skin tissue At day 0 a biopsy will be taken from the thigh and leg ulcer The biopsy from the thigh will require sutures and will be removed in ten days Sometime between weeks 1 and 3 week 6 week 24 and week 48 6 month follow-up visits a biopsy will be taken from the ulcer wound if the ulcer has not healed If the ulcer is healed at the week 48 visit a light scraping of the healed wound will be performed
Study examinations All study examinations will include observation measurement and photography
We can only admit women of childbearing age to the study if they are not breast feeding not pregnant or have been surgically sterilized or are using effective birth control Because the effects of the proposed treatments on a fetus are unknown we will remove from the study any woman who becomes pregnant while receiving BSC applications day 0-week 3 and suggest another method of treatment
We will randomly assign randomize study participants to either the bioengineered skin group or control group compression therapy with a multilayered compression bandage Regardless of the group to which a patient is assigned we expect participation in this study for 12 months following the start of study treatment We will examine each patient at the screening visit 2 weeks before randomization and then again 3-4 days before the start of treatment to make sure the wound is free of any signs of infection After the initial randomization visit we will examine the wound once a week for 24 weeks or until the wound heals whichever is earlier As soon as we have determined that the wound is completely healed we will ask the patient to return once a month for 6 months to make sure it remains healed
Bioengineered skin group We will apply BSC to the wound and cover it with xeroform dressing foam bolster gauze dressing and compression bandage If we do not note any improvement at the week 6 visit we will apply BSC on the wound a second time
Control group We will place a multilayered compression bandage on the wound of participants assigned to this group
Biopsies small piece of skin tissue At day 0 a biopsy will be taken from the thigh and leg ulcer The biopsy from the thigh will require sutures and will be removed in ten days Sometime between weeks 1 and 3 week 6 week 24 and week 48 6 month follow-up visits a biopsy will be taken from the ulcer wound if the ulcer has not healed If the ulcer is healed at the week 48 visit a light scraping of the healed wound will be performed
Study examinations All study examinations will include observation measurement and photography
We can only admit women of childbearing age to the study if they are not breast feeding not pregnant or have been surgically sterilized or are using effective birth control Because the effects of the proposed treatments on a fetus are unknown we will remove from the study any woman who becomes pregnant while receiving BSC applications day 0-week 3 and suggest another method of treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-060 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AR046557 |
| R01AR046557 | NIH | None | None |