Porcine vs Bovine Collagen Dressings for Wound Healing

Recruiting at 1 trial location

Overseen By Amy C Killeen, DDS, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Must not be taking: Bisphosphonates

Disqualifiers: Radiation therapy, Pregnancy, Bone healing conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 6 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether porcine (from pigs) or bovine (from cows) collagen dressings work better for healing after tooth extractions. Researchers aim to assess how these dressings affect the thickness of the soft tissue and the density of the bone during healing. The trial seeks healthy individuals who need a premolar or front tooth removed and have not smoked. Participants must also attend follow-up visits to monitor their healing progress. As an unphased trial, this study provides a unique opportunity to contribute to dental research and enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both pig and cow collagen dressings are generally safe for humans. Pig collagen membranes, used in some dental procedures, come from purified pig tissue. They are strong and flexible, with strict safety standards followed during production.

Cow collagen dressings, derived from cow tissue, are often used in wound care. They aid healing by creating a supportive environment for new tissue growth and naturally break down in the body over time.

Both types of collagen dressings have been used in medical settings and are well-tolerated. No major reports of side effects have emerged from their use in wound care or dental settings, indicating they are generally safe for human wounds. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about porcine and bovine collagen dressings because they offer a new approach to wound healing, particularly after tooth extractions. Unlike traditional gauze or synthetic dressings, these treatments use natural collagen derived from animals, which might enhance the healing process by providing a scaffold for new tissue growth. The porcine collagen membrane is especially promising as it may better mimic human tissue, potentially leading to quicker and more effective healing. Meanwhile, bovine collagen dressings are already known for their wound healing properties, but comparing them to porcine collagen could reveal superior benefits of one over the other, paving the way for more tailored and effective wound care solutions.

What evidence suggests that this trial's treatments could be effective for wound healing?

This trial will compare the effectiveness of porcine collagen membranes and bovine collagen dressings for wound healing after tooth extraction. Research has shown that porcine (pig) collagen membranes can increase bone levels both vertically and horizontally after tooth removal. This improvement can occur in just six months, indicating that the porcine membrane supports bone growth at the extraction site.

For bovine (cow) collagen dressings, studies suggest they can speed up healing and reduce pain after tooth extraction. They also positively influence the healing process. Both treatments show promise for recovery after tooth removal, with porcine collagen primarily supporting bone growth and bovine collagen aiding in faster healing and pain reduction. Participants in this trial will receive either the porcine collagen membrane or the bovine collagen dressing to evaluate these effects. ^{6 7 8 9 10}

Who Is on the Research Team?

Amy C Killeen, DDS, MS

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who need a front tooth or premolar extracted and grafted, are in good health overall, and don't smoke. They must be willing to consent to the study's procedures. People can't join if they've had radiation therapy or used bisphosphonates, are pregnant or breastfeeding, have conditions that affect bone healing, or can't make follow-up visits.

Inclusion Criteria

I am between 18 and 65 years old and do not smoke.

Willing to provide informed consent

I am in good overall health.

Exclusion Criteria

Pregnancy or breastfeeding

I have had radiation therapy or used bisphosphonates.

I cannot attend follow-up visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Atraumatic tooth extraction with either porcine collagen membrane or bovine collagen dressing placement, followed by grafting with DFDBA:FDBA bone particulate

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including histological analysis and CBCT evaluation

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bovine Collagen Dressing
• Porcine Collagen Membrane

Trial Overview The study aims to see which works better for healing after a tooth is pulled: a wound dressing made from pig collagen (porcine membrane) versus one from cow collagen (bovine dressing). It will look at changes in soft tissue thickness and bone density at the site of the extraction.

How Is the Trial Designed?

Group I: Porcine Collagen Membrane Experimental Treatment 1 Intervention

Atraumatic tooth extraction with porcine collagen membrane placement

Group II: Bovine Collagen Dressing Active Control 1 Intervention

Atraumatic tooth extraction with bovine collagen dressing placement

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Published Research Related to This Trial

The study compared four collagen products—Biopad, Promogran, Colactive, and Puracol—on their ability to interact with biological tissues and promote wound healing.

Results indicated that each collagen product interacts differently with enzymes and cells in the wound environment, suggesting that their effectiveness in restoring the healing process may vary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A morphological and biochemical analysis comparative study of the collagen products Biopad, Promogram, Puracol, and Colactive. Karr, JC., Taddei, AR., Picchietti, S., et al.[2019]

In a study involving swine, two types of polymeric wound dressings (hydrocolloid and polyurethane) significantly enhanced the healing process by increasing collagen production and accelerating epidermal resurfacing by 40% compared to air-exposed wounds.

The new collagen matrix implant reduced wound contraction, indicating it may be beneficial for minimizing scarring, while the occlusive dressings did not affect wound contraction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dermal wound repair: role of collagen matrix implants and synthetic polymer dressings. Leipziger, LS., Glushko, V., DiBernardo, B., et al.[2019]

New bovine collagen membranes are effective as biological dressings for partial-thickness burn wounds, showing similar healing times to porcine skin, with no significant differences in healing duration for both superficial and deep burns.

The perforated version of the collagen membranes demonstrated slightly better healing times compared to the nonperforated version, suggesting that the design of the dressing may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical application of new bovine collagen membranes as a partial-thickness burn wound dressing. Sakiel, S., Grzybowski, J.[2006]

In a case series of 20 patients with chronic wounds, the use of bovine-derived, 100% native type I collagen dressings resulted in an 83.3% wound closure rate, with healing times ranging from 13 to 68 days for most patients.

The collagen treatment was well tolerated, with only minor side effects (3 cases of dermatitis) that resolved with corticosteroid treatment, indicating its safety for use in chronic wound management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a bovine 100% native collagen for the treatment of chronic wounds: a case series. Shah, SV., Chakravarthy, D.[2016]

A study involving sera from fifty patients with autoimmune diseases (scleroderma, rheumatoid arthritis, and systemic lupus erythematosus) found no significant difference in antibody levels to bovine collagen implants compared to the normal population.

This suggests that the contraindication for using bovine collagen implants in patients with autoimmune diseases may need to be reconsidered, as these patients did not show elevated antibodies that could indicate an adverse reaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connective tissue diseases and bovine collagen implants. McCoy, JP., Waldinger, TP., Cohen, KA., et al.[2019]

The use of bovine collagen matrix in wound healing significantly enhances the migration and organization of stromal and epithelial cells, leading to faster and more organized healing compared to wounds treated with pressure alone.

Histological analysis of biopsy sites showed that collagen matrix-treated wounds exhibited increased hyaluronic acid and better granulation tissue organization, indicating improved wound healing and reduced scarring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histologic and immunohistochemical features in biopsy sites in which bovine collagen matrix was used for hemostasis. Smith, KJ., Skelton, HG., Barrett, TL., et al.[2019]

Porcine-derived collagen (TheraFill®) is as effective as bovine-derived collagen for soft-tissue augmentation, with similar improvements in wrinkle severity observed in a study of 73 healthy volunteers.

Porcine atelocollagen injections do not require skin testing like bovine collagen, and while some adverse effects were noted (mostly redness), the overall safety profile is favorable, making it a viable alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study of the effectiveness and safety of porcine and bovine atelocollagen in Asian nasolabial fold correction. Moon, SH., Lee, YJ., Rhie, JW., et al.[2022]

Ovine tendon collagen type-I (OTC-I) was successfully extracted and tested for safety and biocompatibility, showing no adverse reactions in animal models, indicating it is safe for use in wound care.

The OTC-I biomatrix demonstrated excellent biocompatibility with no signs of skin irritation or sensitization, making it a promising candidate for future clinical trials in chronic wound management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological Safety Assessments of High-Purified Ovine Collagen Type I Biomatrix for Future Therapeutic Product: International Organisation for Standardisation (ISO) and Good Laboratory Practice (GLP) Settings. Fadilah, NIM., Ahmat, N., Hao, LQ., et al.[2023]

A study on the safety of a collagen wound dressing made from bovine derm showed no significant toxicity in mice and rats after various administration routes, including intraperitoneal, subcutaneous, and oral, as well as intravenous saline extracts.

The only observed side effect was local irritation at the injection site, suggesting that collagen wound dressings could be safely used in clinical practice with minimal risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and subacute toxicity studies on collagen wound dressing (CAS) in mice and rats. Takeda, U., Odaki, M., Yokota, M., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9989051/

Collagen Versus Xenograft Bovine Bone Inserted Into ... Collagen appears to support faster wound healing rate, higher potential influence on socket healing and decreased pain perception than xenograft bovine bone.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12011449/

Assessing New Collagen Therapies for Wound Healing This study evaluated the efficacy of new collagen‐based products and compared them to commercial products in a murine model of cutaneous healing.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05802602/porcine-membrane-vs-bovine-wound-dressing-in-human-tooth-extraction-sites

Porcine Membrane vs Bovine Wound Dressing in Human ... The purpose of this study is to compare the effectiveness of a porcine collagen membrane to a bovine collagen wound dressing for atraumatic extractions.

4. mdpi.com mdpi.com/2310-2861/11/4/271

Collagen-Based Wound Dressings: Innovations, ... This review thoroughly analyzes collagen dressing advances, examining different formulations such as hydrogels, films, and foams that enhance wound care.

5. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2022.978407/full

The clinical efficacy of collagen dressing on chronic wounds Collagen dressing increases the wound healing rate and may be an effective and safe treatment for chronic wound management.

6. dermarite.com dermarite.com/product/dermacol/

Collagen Matrix Dressing - Wound Care DermaCol is an advanced wound care dressing that turns into a soft gel sheet. It can be trimmed & layered for proper wound care management. Purchase today!

7. ad-surgical.com ad-surgical.com/collagen-wound-dressing-649/?srsltid=AfmBOoqEgr8fx90f01R5Oz9FJWyDEgQZ0KhmfHcHd3porqq29eKSnndt

WOUND FREE Collagen Wound Dressing Pads Made of 100% bovine collagen, WOUND FREE Resorbable Collagen Wound Dressing Pads encourage the body to heal wounds quickly and effectively.

8. dermarite.com dermarite.com/product/dermacol-100-sheet/

DermaCol™ 100 Sheet This microfibrillar Type 1 bovine collagen provides a physiologically favorable environment that encourages wound healing. Not made with natural rubber latex.

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/K152600.pdf

510(k) Summary of Safety and Effectiveness Collagen Dental Wound Dressings can be removed, replaced or left in situ. If left in situ the dressings will be essentially resorbed in 30 days.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12359144/

Collagen-Based Products in Wound, Skin, and Health Care Collagen, the most abundant structural protein in the human body, plays a vital role in wound healing, tissue repair, and skin integrity.