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Calcium Corner

Condition: Post-Surgical Wound Care

November 2009
1943-2704
Wounds 2009;21(11).

Acupuncture and Post-Surgical Wound Healing

This study is currently recruiting participants.

Summary: The purpose of this study is to determine if acupuncture improves wound healing. The prospective, randomized, controlled pilot study examines the effects of acupuncture on surgical site complications in patients undergoing coronary artery bypass grafting. The participating investigators at the University of California, San Francisco (UCSF) are aware that the amount of oxygen that gets delivered to tissue is the best predictor of how well a wound will heal and are therefore measuring changes in tissue oxygen of wounds before and after acupuncture treatments. The UCSF Wound Healing Laboratory has solidified two specific observations. The first observation was that without adequate oxygen delivery, many processes of wound healing cannot proceed normally-particularly resistance to infection, collagen deposition, angiogenesis, and inflammation. Secondly, hypoxic conditions are unfortunately common in chronic and acute wounds, which 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 will cause vasoconstriction in addition to impairing oxygen delivery. Numerous preliminary studies have shown that acupuncture decreases SNS activation, pain, and anxiety. Additionally, there is evidence that acupuncture enhances circulation of blood. The investigators therefore hypothesize that acupuncture will facilitate wound healing.      

Location: University of California, San Francisco      

Sponsor: University of California, San Francisco      

Principle investigator: Harriet W. Hopf, MD, University of California, San Francisco      

Identifier: NCT00260494

Study of the Efficacy and Safety of Pregabalin Compared to Placebo for Treatment of Post-Surgical Pain From Hysterectomy

This study is currently recruiting participants.      Summary: The purpose of this interventional, treatment, randomized, double blind study is to assess the efficacy of pregabalin compared to placebo on pain following hysterectomy, measured using subject reported assessments of pain. In order to be eligible for this study, female participants must be 25-70 years of age. Inclusion criteria consist of the following: participants will have elective total abdominal hysterectomy using a transverse incision with or without bilateral salpingo-oophorectomy; the total hysterectomy may however be cervix sparing; the participants are expected to remain in the hospital or immediate care facility for a minimum of 2 days following surgery; and each participant's preoperative health is graded as the American Society of Anesthesiologist P1 to P2. The study's exclusion criteria consist of the following: participants having vaginal hysterectomy (whether laparoscopically assisted or not); participants having additional procedures (such as those involving the bladder) at the same time as the total abdominal hysterectomy; the use of nerve block, spinal anesthesia or epidural anesthesia for post-surgical pain control; participants who have been using any opioid medications 2 weeks or more continuously within 3 months prior to the screening visit; and the participant has taken any NSAID or any analgesic other than acetaminophen within 3 days prior to surgery or is unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol during the study.      The study began in May 2007 and will conclude in April 2010 with an estimated enrollment of 460 participants.      Location: N/A      Sponsor(s): Pfizer      Principle investigator: Pfizer Study Director      Identifier: NCT00468845

Efficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars

This study is currently recruiting participants.      

Summary: The overall goal of this study is to determine the efficacy of Tocotrienol (TCT), a natural form of vitamin E, in preventing or reducing scar formation in human skin wounds. Scar formation is the physiological and inevitable end point of mammalian wound healing and there is substantial evidence that inflammation is an essential prerequisite for scarring. Although scar tissue restores the normal skin barrier, the new tissue is inferior in structural, aesthetic, and functional respects. The mammalian wound healing response may have originated during the time of high susceptibility to infection. Mammalians may have developed speed optimized wound healing where a multiple redundant compensating rapid inflammatory response allows the wound to heal quickly without infection. The scar is then the price mammalians have to pay for evolutionary survival following wounding. TCT may be an effective tool to prevent or reduce normal, hypertrophic, or keloid scarring by mediating the inflammatory response. TCT is a safe and convenient treatment that can be ingested or used topically.      

Location: Ohio State University Department of Surgery, Columbus      
Sponsor: Ohio State University      
Principle investigator: Chandan K. Sen, PhD, Ohio State University      
Identifier: NCT00700791

Endoscopic Vacuum-assisted Closure of Intrathorathic Postsurgical Leaks (EVACoIL)

This study is currently recruiting participants.      

Summary: The purpose of this study is to determine the short- and long-term outcome of endoscopic vacuum assisted closure of intrathoracic postsurgical leaks. Intrathoracic leakage is a serious complication after esophageal surgery. The reported incidence of esophageal anastomotic leaks after gastrectomy and esophagectomy ranges from 5% to nearly 30%. Within the last 10 years endoscopic treatment has changed the approach to intrathoracic anastomotic leakages. Application of metal clips, injection of fibrin glue, and placement of self expanding metal or plastic stents have been reported to successfully achieve closure of postoperative anastomotic leaks in approximately 66%-100% of patients. Alternative endoscopic treatment modalities are welcome especially in cases of failure of the above mentioned endoscopic treatment modalities to prevent the necessity of surgical re-intervention, which is associated with high mortality or mutilating surgical outcomes such as proximal diversion with cervical esophagostomy. Vacuum-assisted closure (V.A.C.) is an established treatment modality for extensive cutaneous infected wounds. The V.A.C. system device is based on a negative pressure applied to the wound by means of a vacuum-sealed sponge tissue. The sponge results in formation of granulation tissue, while the vacuum removes wound secretions and reduces edema and therefore improves blood flow, all together achieving consecutive wound closure. Most recently, the endoluminal application of a vacuum assisted wound closure system for the closure of rectal anastomotic fistulas has been reported. The investigators reported the successful closure of intrathoracic anastomotic leaks in two cases by endoscopic placement of a vacuum-assisted closure system.      

Location: Hannover Medical School, Hannover, Germany      
Sponsor(s): Hannover Medical School      
Principle investigator: Jochen Wedemeyer, MD, Department of Gastroenterology, Hepatology, and Endocrinology, Hannover Medical School      
Identifier: NCT00876551

The information contained in this update was summarized from www.clinicaltrials.gov. Copyright © US National Library of Medicine.

References

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