Applications in General and Colorectal Surgery

Acute Abdominal Wall Dehiscence with EPIFIX as a protective Barrier⁶

Challenge

A 62-year-old obese male, BMI of 29, type II diabetes, with a history of hypertension, myocardial infarction with stent placements, multiple abdominal surgeries, and over 40 years of cigarette smoking, underwent large ventral hernia repair. At one week post-op, the patient developed ischemia at the incision line, which led to an incisional dehiscence.

Studies have shown a direct correlation between the number of comorbidities and clinical outcomes. A significant rise in complications, length of stay, and mortality rates is associated with the rise in number of patient comorbidities.^7-9

Surgical Intervention

The patient was managed with serial debridement and wet-to-dry dressings for two months, then placed on negative pressure wound therapy (NPWT) for four weeks at home. After one month of NPWT, the wound had only decreased by 30%. NPWT was discontinued, and EPIFIX was applied every other week, instead of weekly, due to the travel distance for the patient.

Follow-Up

Upon examination at his two month EPIFIX follow-up visit, the wound was fully closed and re-epithelialized. The patient returned for a routine one-year visit and has remained fully closed and asymptomatic.

Following Debridement

Four weeks of NPWT, only 30% size reduction, first EPIFIX 4 cm x 4 cm applied

Week 2: Two 2 cm x 3 cm EPIFIX applied

Week 4: One 2 cm x 3 cm EPIFIX applied

Week 8: Wound closed and stable

Colostomy Reversal with AMNIOFIX¹⁰

Challenge

A 68-year-old male underwent an emergency Hartmann’s procedure with a rectosigmoidectomy and end colostomy with a rectal pouch, due to a perforation of the sigmoid colon from acute diverticulitis. Though wound healing in elderly people is not necessarily impaired, age-related changes are evident. Comorbidities, which are associated with impaired healing, are more prevalent in older patient populations and can delay healing by 20-60%.¹¹ Anastomotic leakage is the most common and much-feared intraoperative complication in colostomy reversal.^12,13 One study showed the anastomotic leakage rate at as high as 3.8%.¹⁴ In addition to anastomotic leakage, other common postoperative complications include wound infection, incisional hernia, ileus, and enteric fistula formation.^12,13

Surgical Intervention

Five months later, when the patient’s overall condition improved, a colostomy reversal using a single-port laparoscopic technique with AMNIOFIX was performed. A 2 cm x 6 cm AMNIOFIX graft was placed laparoscopically as a protective barrier on the colorectal anastomotic stapled site and was stitched into place with absorbable sutures.

Follow-Up

The patient was seen two weeks after the surgery with no postoperative complications. The patient was having normal bowel movements daily.

Single port laparoscopic approach

2 cm x 6 cm AMNIOFIX placed on anastomosis

Retrospective multicenter study compared colonic anastomoses¹⁵:

• With AMNIOFIX: (n=556) and without a protective ostomy AMNIOFIX was used a protective barrier to support the healing cascade
• Without AMNIOFIX: Based on historical literature controls (n=99,879 Premier Healthcare Database, PHD and n=13,684 National Surgical Quality Improvement Program, NSQIP)

Methods:

• Primary endpoint: Incidence of any hospital readmission within 30-days of colorectal surgery
• Secondary endpoint: Anastomotic leak was defined to match those used by the control studies: 1) minor leak requiring percutaneous intervention or major leak requiring laparotomy (NSQIP) or 2) reoperation, reanastomosis, stent, colostomy, drainage, and/or abscess from day 2 up to 30 days postop (PHD)

Study design:
Chart review of consecutive adults with a primary colectomy who received AMNIOFIX directly applied to a colorectal anastomosis without a protective ostomy between 01JAN16 and 30JUN24. The study design included a comparison to historical controls without AMNIOFIX from the PHD and NSQIP databases.