AlloWrap for Post-ACDF Inflammation

Overseen By Elizabeth Esterl, DNP, MS, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AlloSource

Must not be taking: NSAIDs, Steroids

Disqualifiers: Osteoporosis, Active malignancy, Autoimmune, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to obtain evidence of the effectiveness of AlloWrap Amniotic Membrane in the reduction of soft tissue swelling in two-level ACDF procedures.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have taken NSAIDs (non-steroidal anti-inflammatory drugs) within 7 days before surgery.

What data supports the effectiveness of the treatment AlloWrap® Amniotic Membrane for reducing inflammation after ACDF surgery?

Research shows that amniotic membrane, like AlloWrap, can help reduce inflammation and aid healing in various conditions, such as tendon injuries and dental tissue regeneration, suggesting it might also be effective for post-surgery inflammation. ^{1 2 3 4 5}

Is AlloWrap (amniotic membrane) generally safe for use in humans?

Research on amniotic membranes, like AlloWrap, shows they are generally safe for use in humans, with studies indicating they help in wound healing and reduce inflammation without significant complications. ^{3 5 6 7 8}

What makes the AlloWrap treatment unique for post-ACDF inflammation?

AlloWrap, made from amniotic membrane, is unique because it helps reduce inflammation and promote healing by providing growth factors and anti-inflammatory properties, unlike traditional treatments that may not offer these regenerative benefits. ^{4 5 8 9 10}

Research Team

Jill Bagdasarian

Principal Investigator

AlloSource

Elizabeth Esterl, DNP, MS, RN

Principal Investigator

AlloSource

Eligibility Criteria

This trial is for adults over 18 with cervical spine issues like stenosis or disc disorders, who haven't found relief through non-surgical treatments. They must understand the study and be scheduled for a specific spinal fusion surgery. Exclusions include those with certain bone diseases, recent steroid injections or NSAIDs use, major health risks, recent substance abuse treatment, other clinical trials participation within 90 days, infections including HIV/Hepatitis B/C, mental impairment affecting study compliance, immune system issues requiring treatment like chemotherapy or radiation therapy.

Inclusion Criteria

Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol

I have been diagnosed with a neck condition or nerve compression confirmed by an MRI or CT scan.

I haven't found relief from non-surgical treatments for over 6 weeks, or I have worsening muscle weakness or unbearable pain.

Exclusion Criteria

I have had surgery on my neck before.

I need surgery to join two or more of my neck bones due to symptoms.

I have inflammation in the neck bones.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo two-level anterior cervical discectomy and fusion (ACDF) procedures with or without the use of AlloWrap®

1 day

1 visit (in-person)

Follow-up

Participants are monitored for reduction in soft tissue swelling and other outcomes post-operatively

12 months

Multiple visits at 1, 3, 6, and 12 months

Treatment Details

Interventions

• AlloWrap® Amniotic Membrane

Trial Overview The trial tests AlloWrap Amniotic Membrane's effectiveness in reducing soft tissue swelling after two-level Anterior Cervical Discectomy and Fusion (ACDF) procedures. Participants will receive this membrane during their scheduled surgery to see if it helps decrease inflammation better than standard surgical practices without AlloWrap.

Participant Groups

Group I: AlloWrap Group Experimental Treatment 1 Intervention

AlloWrap used in surgery

Group II: Standard of Care Group Active Control 1 Intervention

Standard of Care - No AlloWrap used during surgery

Who Is Running the Clinical Trial?

AlloSource

Lead Sponsor

Trials

10

Recruited

700+

References

1. Iran pubmed.ncbi.nlm.nih.gov

Evaluation of clinical, antiinflammatory and antiinfective properties of amniotic membrane used for guided tissue regeneration: A randomized controlled trial. [2022]

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

Transplantation of amniotic membrane to the subretinal space in pigs. [2021]

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

Amniotic membrane for reducing the formation of adhesions in strabismus surgery: experimental study in rabbits. [2014]

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

Clinical and Histologic Evaluation of Partial Achilles Tendon Injury Repair with Amniotic Membrane in Rats. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Human Amniotic Membrane for the Treatment of Cryptoglandular Anal Fistulas. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Application of amniotic membranes in reconstructive surgery of internal organs-A systematic review and meta-analysis. [2023]

7. Ireland pubmed.ncbi.nlm.nih.gov

Controlled comparison of interceed and amniotic membrane graft in the prevention of postoperative adhesions in the rabbit uterine horn model. [2019]

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

Amniotic membrane grafts for the prevention of esophageal stricture after circumferential endoscopic submucosal dissection. [2021]

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

Clinical Experience: Using Dehydrated Human Amnion/Chorion Membrane Allografts for Acute and Reconstructive Burn Care. [2022]

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

Evaluation of tissue healing and adhesion formation after an intraabdominal amniotic membrane graft in the rat. [2008]