Altrazeal™ Versus Aquacel® Ag for Partial Thickness Skin Donor Sites

ULURU Inc.

Status

Completed

Conditions

Partial-thickness Skin Donor Sites

Treatments

Device: Aquacel Ag

Device: Altrazeal

Study type

Interventional

Funder types

Industry

Identifiers

NCT01062204

UC-6U1102

Details and patient eligibility

About

The primary objective of the study is to evaluate the time to wound healing in skin graft donor sites with a new treatment (Altrazeal dressing) compared to standard of care treatment (Aquacel Ag- Carboxymethylcellulose dressing) in partial thickness skin graft donor sites.

Full description

This is a single center, randomized, therapeutic exploratory study to monitor wound healing with the new AltrazealTM flexible hydrogel nanoparticle dressing compared to the existing treatment standard (Aquacel ® AG sodium carboxymethylcellulose dressing) in patients with at least two skin graft donor sites. 40 patients with at least 2 skin graft donor sites, ranging in age from 3 and 85 years, will be enrolled. Children (age 3 to 16 inclusive) will be included in the patient population if possible, but should not exceed 50% of all patient enrolled. Researchers will first identify the skin donor sites (A and B) for each patient and take baseline digital images and measurements immediately following surgery (Day 1). Trained personnel will apply the dressings provided by the Sponsor for and labeled as A or B by the Sponsor in a random fashion. Typical meticulous wound care and adequate analgesic medical coverage will be provided for the duration of the study. Both the patient and medical staff will be trained on instructions for use of each dressing. The patients will be monitored daily as part of standard procedure while they are in the in-patient setting. If and when patients move to the out-patient setting, they will continue to be monitored at least every-other-day at the study center. On each day (in-patient) or every-other-day (outpatient), the physician will determine whether each skin graft donor site has healed per standard care guidelines (i.e. > 95% re-epithelization), and pain and adverse events will be monitored. The last study visit will be on Day 24 or on the day when both wounds have been assessed as "healed", whichever comes first.

Enrollment

40 estimated patients

Sex

All

Ages

3 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patient is between the ages of 3 and 85 Note: In order to maintain a broad representation of ages, no more than 50% of the patients enrolled in the study should be between the ages of 3 and 16, inclusive.
Patient is in general good health
Patient has two independent skin donor sites of approximately the same dimensions.
Patient is willing and able to cooperate with the protocol for duration of study.
Patient is capable of providing informed consent and HIPAA authorization
Ability to read and speak either English or Spanish

Exclusion criteria

Male or female patient is less than 3 years of age or more than 85 years of age
Patient has acutely infected wounds
Patient has wounds with surrounding cellulites
Patient has a history of hypersensitivity to any components of either the nanoparticle or sodium carboxymethylcellulose dressing, or any known sensitivities to other hydrogel bandage treatments
Patient has a concurrent clinical condition, which in the judgment of the Investigator could either pose a health risk to the patient while participating in this study, or could potentially influence the outcome of the study;
Patient has history of poor wound healing or any skin/immune system condition that would increase likelihood of wound irritation, infection or increase chance of early termination
Patient is unable to communicate or to cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.