Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260494
Status:
TERMINATED
Last Update Posted:
2013-07-23
First Post:
2005-11-29
Brief Title:
Acupuncture and Post-Surgical Wound Healing
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Acupuncture and Post-Surgical Wound Healing in Coronary Artery Bypass Graft Patients Undergoing Open Saphenous Vein Graft Harvest
Status:
TERMINATED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No difference in primary outcomes at interim analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if acupuncture improves wound healing Since we the investigators at the University of California San Francisco UCSF know that how much oxygen is delivered to tissue is the best predictor of how well a wound will heal we are measuring changes in tissue oxygen of wounds before and after acupuncture treatments We are focusing on the leg wounds of coronary artery bypass graft CABG patients who have their saphenous veins harvested in an open fashion since this is a fairly well controlled patient model
Detailed Description:
This is a prospective randomized controlled pilot study of the effects of acupuncture on surgical site complications in patients undergoing coronary artery bypass grafting The past forty years of research in the UCSF Wound Healing Laboratory have solidified the following observations
1 without adequate oxygen delivery many processes of wound healing cannot proceed normally particularly resistance to infection collagen deposition angiogenesis and inflammation and
2 hypoxic conditions unfortunately are common in chronic and acute wounds and often result from subcutaneous vasoconstriction
Sympathetic nervous system SNS activators and other vasoconstrictors have been shown to produce wound hypoxia Activation of the SNS by any means including pain and anxiety causes vasoconstriction and impairs oxygen delivery Simple means that limit SNS activity have been shown to increase perfusion and oxygen tension and thereby facilitate wound healing Many preliminary studies have shown that acupuncture decreases SNS activation pain and anxiety In addition there is evidence that acupuncture enhances circulation of blood We therefore hypothesize that acupuncture will facilitate wound healing We aim to quantify changes in anxiety pain stress hormones and perfusion and oxygenation induced by these interventions as well as wound healing outcomes including infection and other wound complications
1 without adequate oxygen delivery many processes of wound healing cannot proceed normally particularly resistance to infection collagen deposition angiogenesis and inflammation and
2 hypoxic conditions unfortunately are common in chronic and acute wounds and often result from subcutaneous vasoconstriction
Sympathetic nervous system SNS activators and other vasoconstrictors have been shown to produce wound hypoxia Activation of the SNS by any means including pain and anxiety causes vasoconstriction and impairs oxygen delivery Simple means that limit SNS activity have been shown to increase perfusion and oxygen tension and thereby facilitate wound healing Many preliminary studies have shown that acupuncture decreases SNS activation pain and anxiety In addition there is evidence that acupuncture enhances circulation of blood We therefore hypothesize that acupuncture will facilitate wound healing We aim to quantify changes in anxiety pain stress hormones and perfusion and oxygenation induced by these interventions as well as wound healing outcomes including infection and other wound complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None