Clinical Trial: Arista for ALT Donor Sites to Reduce Drain Output

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Multi-Institutional Randomized Controlled Trial Evaluating Use of Arista Absorbable Surgical Hemostatic Powder in Anterolateral Thigh Donor Sites

Brief Summary:

This is a single-blinded multi-institutional randomized controlled trial to evaluate the effectiveness of Arista hemostatic matrix powder (Arista® AH, C. R. Bard, Inc. Davol, Warwick, RI) in reducing drainage output in anterolateral thigh (ALT) free flap donor sites. Increased drainage from donor sites can lead to seroma formation with possible secondary infection, delayed hospital discharge, and additional home care needs for drain care. Arista is an inert plant based absorbable surgical hemostatic powder that can be easily applied to broad surgical fields to reduce bleeding and seroma rates. Therefore, its application to free flap donor sites may bear significant potential benefit.

Specific Aim 1: The main hypothesis of the study is that the use of Arista in anterolateral thigh (ALT) free flap donor sites prior to closure will reduce postoperative drain outputs and time to drain removal compared to ALT donor sites closed without Arista.

Specific Aim 2: This study will also evaluate the secondary hypotheses that Arista will reduce postoperative ALT donor site seromas and patient hospital length of stay.

Detailed Summary:

Free tissue transfer is a commonly performed procedure, especially at tertiary care hospitals. In free tissue transfer, "spare tissue" from one area of the body (donor site) is re-implanted to an area that is need of reconstruction (defect site). When relocated, the "spare tissue" is given vitality and blood supply at its new location by microscopically sewing and connecting its feeding artery and vein to an artery and vein in or near the defect site. Hence, this operation is referred to as "microvascular free tissue transfer" or "free flap". Defect sites most commonly result from tumor or cancer removal and trauma related injuries. Free flaps are frequently used to reconstruct breast tissue after mastectomy, head and neck cancer resections, extremity injuries, and chronically infected wounds. The indications, utilization, and expertise in free flap surgery continue to grow, providing patients with enhanced outcomes of otherwise difficult cancers and wounds.

Since its original description in 1984 the ALT microvascular free flap has become an increasingly integral part of head and neck reconstructive surgery.1, 2 ALT free flaps have been shown to be a reliable method for several reconstructive procedures with minimal donor site morbidity.2-4 The ALT free flap is composed of skin, subcutaneous tissue, and fat of the anterolateral thigh. The blood supply to this area is from the lateral circumflex femoral artery and vein. These vessels along with the tissues of the anterolateral thigh are carefully dissected and removed as a single unit to be re-implanted in a different part of the body.

Multiple options exist for soft tissue free flap donor sites similar to the ALT. However, a distinct advantage of the ALT free flap over others is the minimal donor site morbidity that the patient under
Sponsor: University of California, San Francisco

Current Primary Outcome:

• total drain output [ Time Frame: 1-14 days after Surgery ]
  The primary outcome analyzed in this study will be total drain output (mL) in an effort to determine if the addition of Arista to the wound bed decreases overall wound drainage and drain output.
• Development of ALT donor site seroma. [ Time Frame: 30 days postoperative ]
  ALT donor site will be evaluated for seroma
• Timing to Drain Removal [ Time Frame: 30 days postoperative ]
  Given that drain output influences time of drain removal, assessment will be made to determine if timing of drain removal differs between groups.

Original Primary Outcome:

• total drain output [ Time Frame: 1-14 days after Surgery ]
  The primary outcome analyzed in this study will be total drain output (mL) in an effort to determine if the addition of Arista to the wound bed decreases overall wound drainage and drain output. Given that drain output influences time of drain removal, assessment will be made to determine if timing of drain removal differs between groups.
• Development of ALT donor site seroma. [ Time Frame: 30 days postoperative ]
  ALT donor site will be evaluated for seroma

Current Secondary Outcome: Hospital Length of Stay [ Time Frame: 30 days postoperative ]

Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: June 18, 2015
Date Started: July 2016
Date Completion: July 2017
Last Updated: May 12, 2016
Last Verified: May 2016