Health TrialsbyHealthPanel

Amnion Membrane Powder Mohs Study

ConditionWound Heal
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

About this trial

The purpose of this research study is to test the safety of the amnion membrane powder to see if it improves wound healing in patients undergoing Mohs surgery on the scalp.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The subject requires Mohs surgery on the scalp, with the resulting wound extending to the subgalea (all subcutaneous fat removed) and a surface area of at least 4cm2.

The subject is willing to complete all follow-up evaluations required by the study protocol.

The subject is to abstain from any other covering or treatment of the wound(s) for the duration of the study unless otherwise directed by the study surgeon or their surrogate

The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.

Disqualifiers

The subject's wound site is smaller than 4cm2.

The subject's wound site does not extend to the subgalea.

The subject has invasive melanoma or high-risk squamous cell carcinoma (defined by poor differentiation, presence of perineural invasion) in which the standard of care is to be referred for adjuvant radiation oncology

The subject has a microbiologically proven pre-existing local or systemic bacterial infection.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Amnion Membrane Powder

    Drug

    amnion membrane power dose of 0.26 mg/mm3 applied during MOHS scalp surgery

  • Standard of Care

    Drug

    aquaphor ointment applied during MOHS scalp surgery

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Amnion Membrane PowderExperimental treatment 1 intervention
Group B: Standard of CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Infection

Number of participants that developed a wound infection

Time frame
Through week 16
2

Number of Participants with Allergic Reaction

Number of participants with an allergic reaction to the intervention

Time frame
Through week 16
3

Number of Treatment-Related Adverse Events

Number of treatment-related adverse events

Time frame
Through week 16
4

Number of Unscheduled Visits for Wound Bleeding

Number of participants that had an unscheduled visit for wound bleeding

Time frame
Through week 16

Secondary outcomes

1

Time Until Wound Closure

Number of days until wound was completely closed

Time frame
Through week 16
2

Time Until of Wound Closure

Number of days until wound was fully sealed

Time frame
Through week 16
3

Percentage of Re-epithelialization

Percentage of the wound with re-epithelialization

Time frame
Week 1, week 4, week 8, week 12, week 16

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: