Postoperative Management of Groin Flaps for Vascular Coverage

Wound Complication Clinical Trial

Official title:

Postoperative Management of Groin Flaps for Vascular Coverage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477682
• Other study ID #: 15-17005
• Status: Completed
• Phase: N/A
• Start date: November 7, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled trial designed to analyze the impact of bedrest duration on return to functional independence at discharge following sartorius flap for coverage of vascular reconstruction in the groin.

Description:

This is a pilot prospective study with the purpose of evaluating the impact of bedrest duration on outcomes of groin muscle flaps used for groin coverage in patients undergoing open, infrainguinal vascular surgery. The investigators plan to target all patients undergoing groin muscle flaps for vascular groin coverage at UCSF.

All patients undergoing groin flaps will be block randomized into two cohorts: Cohort 1 - one day of bedrest (mobilize on post-op day 2) versus Cohort 2 - 5 days of bedrest (mobilize on post-op day 6).

The investigators perform approximately 50 infrainguinal muscle flaps per year. They aim to enroll 30 patients (15 per cohort).

Outcome measures include: surgical complication rates (including wound and lymphatic complications, readmissions, and reoperations), physical function, hospital length of stay, venous thromboembolism (VTE), and rates of discharge to a skilled nursing facility. The investigators will also examine the impact of bedrest on patient reported outcomes one month following surgery. Patient outcomes will be followed for 3 months post-operatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 30, 2021
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients undergoing muscle flaps following infrainguinal, open vascular surgery. Patients must be ambulatory at baseline. Patients must be able to provide informed consent.

Exclusion Criteria:

• Patients who are unable to provide informed consent. Patients are non-ambulatory at baseline. Patients' clinical status is not amenable towards early ambulation. Enrollment is at the discretion of the vascular and plastic surgeons.

• Bilateral sartorius flaps

Related Conditions & MeSH terms

• Functional Status After Sartorius Flap of the Groin
• Wound Complication

Intervention

Other:
• Early ambulation
Patients who are in the experimental arm will have a shorter duration of bedrest restriction following sartorius surgery (1 day) versus the standard group (5 days bedrest).

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (6)

Evans GR, Francel TJ, Manson PN. Vascular prosthetic complications: success of salvage with muscle-flap reconstruction. Plast Reconstr Surg. 1993 Jun;91(7):1294-302. — View Citation

Fischer JP, Mirzabeigi MN, Sieber BA, Nelson JA, Wu LC, Kovach SJ, Low DW, Serletti JM, Kanchwala S. Outcome analysis of 244 consecutive flaps for managing complex groin wounds. J Plast Reconstr Aesthet Surg. 2013 Oct;66(10):1396-404. doi: 10.1016/j.bjps.2013.06.014. Epub 2013 Jul 5. — View Citation

Fischer JP, Nelson JA, Mirzabeigi MN, Wang GJ, Foley PJ 3rd, Wu LC, Woo EY, Kanchwala S. Prophylactic muscle flaps in vascular surgery. J Vasc Surg. 2012 Apr;55(4):1081-6. doi: 10.1016/j.jvs.2011.10.110. Epub 2011 Dec 29. — View Citation

Genc A. Early mobilization of the critically ill patients: towards standardization. Crit Care Med. 2012 Apr;40(4):1346-7. doi: 10.1097/CCM.0b013e31823b8e44. — View Citation

Greenblatt DY, Rajamanickam V, Mell MW. Predictors of surgical site infection after open lower extremity revascularization. J Vasc Surg. 2011 Aug;54(2):433-9. doi: 10.1016/j.jvs.2011.01.034. Epub 2011 Mar 31. — View Citation

Perme C, Chandrashekar R. Early mobility and walking program for patients in intensive care units: creating a standard of care. Am J Crit Care. 2009 May;18(3):212-21. doi: 10.4037/ajcc2009598. Epub 2009 Feb 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in AM-PAC Score	AMPAC Score measures functional status	1 week
Secondary	Wound infection requiring medication	Described infection requiring antibiotics only, no surgery	3 months
Secondary	Superficial wound dehiscence	Dehiscence of superficial layers (skin and subcutaneous tissue) requiring local wound care. Information will be gathered from medical record as charted by provider describing superficial wound dehiscence or via picture in the chart. This means separation at the skin level and may include, epidermis, dermis or subcutaneous fat or all three.	3 months
Secondary	Deep wound dehiscence	Dehiscence of wound down to fascia, muscle, exposed vessels, requiring surgery. Information will be gathered from medical record as charted by provider or via picture. It will be described as wound dehiscence beyond the subcutaneous tissue down to fascia, muscle or exposed vessel and that required a re-operation by the plastic surgery team.	3 months
Secondary	Wound infection requiring surgery	Wound infection or abscess requiring surgery (debridement, incision and drainage, exploration)	3 months
Secondary	Length of hospital stay	Length of hospitalization following surgery, measured in days	2 weeks
Secondary	Rehabilitation	Type of rehabilitation after surgery (home health, skilled nursing facility, home physical therapy, none)	3 months
Secondary	SF36 Score	This survey measures quality of life and will be used to examine the impact of bedrest on patient reported quality of life outcomes postoperatively. Total scores range from 0-100 with higher scores indicating a more favorable state.	3 months
Secondary	C-reactive protein	A measure of nutritional status, measured on first day of mobilization	1 week. Depending on the assigned group, this will be either on postoperative day two or six.
Secondary	Albumin	A measure of nutritional status, measured on first day of mobilization	1 week. Depending on the assigned group, this will be either on postoperative day two or six.
Secondary	Pre-albumin	A measure of nutritional status, measured on first day of mobilization	1 week. Depending on the assigned group, this will be either on postoperative day two or six.