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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare porcine collagen membrane and bovine collagen wound dressing in human tooth extraction sites. The outcomes measured will be soft tissue thickness changes as well as bone density changes.

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.

What data supports the effectiveness of the treatment Bovine Collagen Dressing for wound healing?

Research shows that bovine collagen dressings can promote wound granulation (new tissue formation) and reduce wound contraction, which helps in healing. Additionally, studies comparing bovine collagen membranes to porcine skin for burn wounds found similar healing times, suggesting bovine collagen is effective as a biological dressing. ^{1 2 3 4 5}

Is it safe to use porcine and bovine collagen dressings for wound healing?

Porcine collagen is considered safe and does not require skin testing before use, while bovine collagen has been used for many years but requires skin testing due to potential risks like bovine spongiform encephalopathy (BSE). In a study, porcine collagen showed similar safety and effectiveness to bovine collagen, with the most common side effect being mild redness. ^{1 3 6 7 8}

How does the porcine vs bovine collagen dressing treatment differ from other wound healing treatments?

Porcine collagen dressings are unique because they are similar to human collagen and do not carry the risk of diseases like bovine spongiform encephalopathy (BSE) associated with bovine collagen. This makes porcine collagen a safer option for wound healing, as it does not require prior skin testing, unlike bovine collagen. ^{1 2 4 6 9}

Research Team

Amy C Killeen, DDS, MS

Principal Investigator

University of Nebraska

Eligibility Criteria

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

I have had radiation therapy or used bisphosphonates.

Pregnancy or breastfeeding

I cannot attend follow-up visits.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A morphological and biochemical analysis comparative study of the collagen products Biopad, Promogram, Puracol, and Colactive. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Histologic and immunohistochemical features in biopsy sites in which bovine collagen matrix was used for hemostasis. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Dermal wound repair: role of collagen matrix implants and synthetic polymer dressings. [2019]

4. Poland pubmed.ncbi.nlm.nih.gov

Clinical application of new bovine collagen membranes as a partial-thickness burn wound dressing. [2006]

5. Japan pubmed.ncbi.nlm.nih.gov

Acute and subacute toxicity studies on collagen wound dressing (CAS) in mice and rats. [2019]

6. Sweden pubmed.ncbi.nlm.nih.gov

Comparative study of the effectiveness and safety of porcine and bovine atelocollagen in Asian nasolabial fold correction. [2022]

7. Switzerland 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Connective tissue diseases and bovine collagen implants. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

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