Wound healing is a complex dynamic process which replacing damaged cells with cells of same origin or with connective tissue scar. Wound healing has four time dependent phases; hemostatic, inflammatory, proliferative, and remolding phase. In each phase, specific resident cells release growth factors and cytokines to move the healing process from one phase to the other till complete healing occurs. Chronic wound stack in or delayed in one of the healing phases commonly inflammatory phase. Chronic wound prevalence is high among the population and increase risk of prolonged hospitalization, infection, and potential amputation. In fact healing these wounds is expensive because the healing process is extremely slow. Therefore, a new treatment
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Specific Aims & Hypothesis:
The objective of this study is to determine the therapeutic effect of adding Hyalomatrix® to different type of chronic surgical wounds underneath negative pressure wound therapy (NPWT) treatment. We hypothesize that the combination of Hyalomatrix® with NPWT will expedite the healing percentage of non-healing surgical wounds. This will be correlated to increase growth factors and interleukins and decrease matrix metalloprotease enzymes collected from the wound in the …show more content…
Subjects withdrawn from the study for infection or other reasons will be replaced. Since the dropout rate is unpredictable, enrollment will continue until 6 subjects in each arm have completed all study visits.
Randomization will be regulated by an envelope system. Sequentially numbered envelopes, each containing a study-arm designation card, will be kept at Dr. Simman’s Sycamore Medical Center Wound Center office. Once a subject is assigned to a study arm, the subject’s initials will be recorded on the designation card. The card with subject’s initials will then be returned to the envelope and kept as the study-arm assignment record. The envelope number will also be used as the subject ID number.
1- Subject Selection:
Potential participants will be evaluated by the study principal investigator for Inclusion/Exclusion criteria. The majority of the subjects will be enrolled at Sycamore Medical
Center’s Wound Center, but subjects may also be enrolled at any participating
Specific Aims & Hypothesis:
The objective of this study is to determine the therapeutic effect of adding Hyalomatrix® to different type of chronic surgical wounds underneath negative pressure wound therapy (NPWT) treatment. We hypothesize that the combination of Hyalomatrix® with NPWT will expedite the healing percentage of non-healing surgical wounds. This will be correlated to increase growth factors and interleukins and decrease matrix metalloprotease enzymes collected from the wound in the …show more content…
Subjects withdrawn from the study for infection or other reasons will be replaced. Since the dropout rate is unpredictable, enrollment will continue until 6 subjects in each arm have completed all study visits.
Randomization will be regulated by an envelope system. Sequentially numbered envelopes, each containing a study-arm designation card, will be kept at Dr. Simman’s Sycamore Medical Center Wound Center office. Once a subject is assigned to a study arm, the subject’s initials will be recorded on the designation card. The card with subject’s initials will then be returned to the envelope and kept as the study-arm assignment record. The envelope number will also be used as the subject ID number.
1- Subject Selection:
Potential participants will be evaluated by the study principal investigator for Inclusion/Exclusion criteria. The majority of the subjects will be enrolled at Sycamore Medical
Center’s Wound Center, but subjects may also be enrolled at any participating