Trial Outcomes & Findings for Topical Collagen Powder for Healing of Acute Full-thickness Wounds (NCT NCT03481907)
NCT ID: NCT03481907
Last Updated: 2023-03-28
Results Overview
Change in wound diameter will be assessed digitally from photographs of the wounds obtained at several distinct time points, both at the time of wounding and afterwards. The diameter of the biopsy wound is measured to reflect a change from baseline in wound size day 0 and again at week 4.
COMPLETED
NA
8 participants
4 weeks after first biopsy
2023-03-28
Participant Flow
Eight healthy volunteers 18 to 75 years old were enrolled after Informed consent form was signed for this study
Healthy patients 18 -75 years included. Patients with impaired wound healing, systemic immunosuppressants use within 2 months, steroid application to the thighs 2 weeks, participation in investigational trials in less than 4weeks , systemic antibiotics use , History of Diabetes Mellitus, bleeding disorders, keloids, hypertrophic scarring, allergy to collagen powders, current or past history of tobacco, alcohol or other illicit drug us and pregnant or nursing females were excluded.
Unit of analysis: left and right thighs of each subject
Participant milestones
| Measure |
All Study Participants
All Subjects will receive 2 punch biopsy created wounds, one on each thigh to provide internalized controls, one thigh wound either left or right randomly which will be treated with primary closure( sutures) other thigh will be treated with Nuvagen collagen powder covered with sterile dressing at time of biopsy and daily thereafter for 4 weeks. Suture(s) will be removed in 2 weeks. Results are read to assess healing with wound size. At week four, both the wounded sites will be biopsied again to assess pathology results for healing tissue evaluation, and treated with primary closure again. Suture(s) will be removed within two weeks.
|
|---|---|
|
Overall Study
STARTED
|
8 16
|
|
Overall Study
Two Biopsies One on Each Thigh at Day 0 With Photo IHC and Histopathological Processing
|
8 16
|
|
Overall Study
One Biopsy Wound Managed With Primary Closure
|
8 8
|
|
Overall Study
Other One Biopsy Wound Managed With Topical Collagen Powder for 4 Weeks
|
8 8
|
|
Overall Study
Photos of Both Wounds Were Taken at Week 46 With a Ruler in the Frame for Size Calibration
|
8 16
|
|
Overall Study
Immunohistochemistry Done at 4 Weeks to Determine Collagen Content by Performing a Second Biopsy
|
8 16
|
|
Overall Study
COMPLETED
|
8 16
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical Collagen Powder for Healing of Acute Full-thickness Wounds
Baseline characteristics by cohort
| Measure |
All Participants
n=8 Participants
Biopsy of one anterior thigh of all patients followed by wound care with Primary Closure. Biopsy of other anterior thigh in all patients followed by wound care with Collagen powder
|
|---|---|
|
Age, Continuous
|
37 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
|
Fitz-Patrick Skin type
Type I
|
1 Participants
n=5 Participants
|
|
Fitz-Patrick Skin type
Type II
|
3 Participants
n=5 Participants
|
|
Fitz-Patrick Skin type
Type III
|
1 Participants
n=5 Participants
|
|
Fitz-Patrick Skin type
Type III-IV
|
2 Participants
n=5 Participants
|
|
Fitz-Patrick Skin type
Type IV
|
0 Participants
n=5 Participants
|
|
Fitz-Patrick Skin type
Type V
|
1 Participants
n=5 Participants
|
|
Fitz-Patrick Skin type
Type VI
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after first biopsyPopulation: 8 voluntary out patients were selected between ages 18 and 75, 2 female subjects. There was one patient with Fitzpatrick Skin type (FST) I, Three were FST II, one FST III, tow, FST III/IV, and one FST V.
Change in wound diameter will be assessed digitally from photographs of the wounds obtained at several distinct time points, both at the time of wounding and afterwards. The diameter of the biopsy wound is measured to reflect a change from baseline in wound size day 0 and again at week 4.
Outcome measures
| Measure |
Primary Closure
n=8 Participants
All Subjects will receive a punch biopsy, on one thigh, which will be closed with primary closure suture(s) , removed in 2 weeks. At week four, the wounded site closure will be measured by its diameter after which the site will be biopsied again for tissue collection to evaluate collagen content by pathology and immunohistochemistry (IHC), and treated with primary closure. Suture(s) will be removed in 2 weeks.
|
Collagen Powder
n=8 Participants
All subjects will receive biopsy on the other thigh, and wound care will again be with NuvagenTM collagen powder. Biopsy wound treated with daily topical collagen powder for up to four weeks . At week four, the wounded site closure will be measured by its diameter after which the site will be biopsied again for tissue collection to evaluate collagen content by pathology and immunohistochemistry (IHC), and treated with primary closure. Suture(s) will be removed in 2 weeks.
|
|---|---|---|
|
Change in Wound Diameter
|
95.94 Centimeters
Interval 91.81 to 99.47
|
95.94 Centimeters
Interval 92.41 to 99.47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 4 weeks after first biopsyPopulation: 8 voluntary out patients were selected between ages 18 and 75, 2 female subjects. There was one patient with Fitzpatrick Skin type (FST) I, Three were FST II, one FST III, tow, FST III/IV, and one FST V.
histopathological processing was performed by HistoWiz, Inc. (Brooklyn, NY) on one baseline sample and both four-week samples, including hematoxylin and eosin (H\&E), CD31 (platelet-derived endothelial cell adhesion molecule-1), and Masson trichrome staining. H\&E staining was used to examine the quality of the epidermis and colla- gen bundles as well as to observe the amount of inflammatory granulation tissue.
Outcome measures
| Measure |
Primary Closure
n=8 Participants
All Subjects will receive a punch biopsy, on one thigh, which will be closed with primary closure suture(s) , removed in 2 weeks. At week four, the wounded site closure will be measured by its diameter after which the site will be biopsied again for tissue collection to evaluate collagen content by pathology and immunohistochemistry (IHC), and treated with primary closure. Suture(s) will be removed in 2 weeks.
|
Collagen Powder
n=8 Participants
All subjects will receive biopsy on the other thigh, and wound care will again be with NuvagenTM collagen powder. Biopsy wound treated with daily topical collagen powder for up to four weeks . At week four, the wounded site closure will be measured by its diameter after which the site will be biopsied again for tissue collection to evaluate collagen content by pathology and immunohistochemistry (IHC), and treated with primary closure. Suture(s) will be removed in 2 weeks.
|
|---|---|---|
|
Collagen Staining in Histopathology
|
125.8 percentage of Masson trichrome staining
Interval 118.49 to 133.11
|
173.40 percentage of Masson trichrome staining
Interval 164.07 to 182.73
|
Adverse Events
Primary Closure
Collagen Powder
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place