Skin substitutes for treating chronic wounds
Snyder DL, Sullivan N, Schoelles KM
Record ID 32014000515
English
Authors' objectives:
What are the U.S. Food and Drug Administration (FDA)-regulated skin substitutes that fall under each of the following pathways: PMA, 510(k), PHS 361 [21 CFR 1270 & 1271]?
For patients with chronic wounds (pressure ulcers, diabetic foot ulcers, venous leg ulcers, or arterial leg ulcers), are skin substitutes more effective than other wound care options (usual or standard care, or usual or standard care plus synthetic dressings, growth factors, skin grafts, or other treatments used as a comparison) in promoting wound healing for a range of outcome measures.
What type and frequency of adverse events are reported in the clinical literature for each of the FDA-regulated skin substitute products?
Authors' recommendations:
Our evaluation of the clinical literature indicates that studies comparing the efficacy of skin substitutes to alternative wound care approaches are limited in number, apply mainly to generally healthy patients, and examine only a small portion of the skin substitute products available in the United States.
Details
Project Status:
Completed
Year Published:
2013
URL for published report:
http://www.ahrq.gov/research/findings/ta/skinsubs/HCPR0610_skinsubst-final.pdf
English language abstract:
An English language summary is available
Publication Type:
Not Assigned
Country:
United States
MeSH Terms
- Humans
- Chronic Disease
- Skin, Artificial
- Wound Healing
- Skin Ulcer
Contact
Organisation Name:
Agency for Healthcare Research and Quality
Contact Address:
Center for Outcomes and Evidence Technology Assessment Program, 540 Gaither Road, Rockville, MD 20850, USA. Tel: +1 301 427 1610; Fax: +1 301 427 1639;
Contact Name:
martin.erlichman@ahrq.hhs.gov
Contact Email:
martin.erlichman@ahrq.hhs.gov
Copyright:
Agency for Healthcare Research and Quality (AHRQ)
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.