Biologic enhancement of wound healing.

Manipulation of the healing process through wound supplementation with agents that are natural contributors to the healing process is an appealing concept. Early experimental studies evaluating wounds supplemented with inflammatory mediators used materials extracted from cell preparations and generated encouraging results. Recombinant technology has allowed the production of larger volumes of these mediators that can be used more practically and safely in the clinical setting. Several clinical trials involving inflammatory mediators as wound supplements are reviewed, and the results of many of the studies are encouraging. Wound supplements are considered drugs, and therefore, they must be demonstrated to be safe and efficacious before they can receive approval for human use by the FDA. It is extremely expensive to carry out the experimental studies required for FDA approval. Because of the expense involved, Regranex is the only supplement that has been tested thoroughly enough to receive FDA approval for use in humans. It is hoped that additional agents will be demonstrated to be safe and efficacious in human trials so that they might become available in the United States in the near future.