NCT03481907

Topical Collagen Powder for Healing of Acute Full-thickness Wounds

Completed NA Results posted Last updated 28 March 2023

What this trial tests

NA trial testing Nuvagen Collagen Powder in Wound of Skin in 8 participants. Completed in 1 November 2018.

Timeline

15 March 2018

Primary endpoint
18 October 2018

1 November 2018

Quick facts

Lead sponsor	Adam Friedman
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	15 March 2018
Primary completion	18 October 2018
Estimated completion	1 November 2018
Sites	1 location across United States

Drugs / interventions tested

• Nuvagen Collagen Powder

Conditions studied

• Wound of Skin — all drugs for Wound of Skin →
• Wound Heal — all drugs for Wound Heal →

Sponsor

Adam Friedman

Who can join

Adults 18 to 75, any sex, with Wound of Skin or Wound Heal. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Wound Diameter Primary · 4 weeks after first biopsy

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.

Group	Value	95% CI
Primary Closure	95.94	91.81 – 99.47
Collagen Powder	95.94	92.41 – 99.47

Collagen Staining in Histopathology Secondary · at 4 weeks after first biopsy

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.

Group	Value	95% CI
Primary Closure	125.8	118.49 – 133.11
Collagen Powder	173.40	164.07 – 182.73

Sponsor's own description

We have designed a pilot study to investigate the effect and potential utility of topical NuvagenTM (collagen powder) on the rate and quality of wound healing in healthy volunteers using the punch biopsy method. After inducing an acute full-thickness wound, the rate of complete healing of a wound treated with topical NuvagenTM (collagen powder) will be compared to the rate of complete healing of a wound treated with primary closure with sutures, the current gold standard. Qualification and semi-quantification of histologic and immunohistochemical markers will be used to assess the maturity and structural stability of the wound bed. Positive findings would suggest that NuvagenTM (collagen powder) may be capable of stimulating the healing of acute wounds in a similar or even superior manner to primary closure, suggesting collagen powder may be used in place of sutures, and encouraging further studies to characterize its therapeutic potential in dermatologic surgery.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Head-to-Head Comparison of Topical Collagen Powder to Primary Closure for Acute Full-Thickness Punch Biopsy-Induced Human Wounds: An Internally Controlled Pilot Study
   Qureshi A, Murphy E, Milando R, Rengifo-Pardo M, et al · · 2019 · cited 3× · PMID 31334925 · DOI 10.1016/j.jaad.2019.06.064