Trial Outcomes & Findings for A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas (NCT NCT00545441)

NCT ID: NCT00545441

Last Updated: 2014-12-17

Results Overview

Healing was defined as "closure of external opening with absence of abscess, drainage and pain."

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 86 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2014-12-17

Participant Flow

Participant milestones

Measure	Surgisis® AFP Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.	Flap Flap: Advancement flap surgery is performed; no anal fistula plug is placed
Overall Study STARTED	44	42
Overall Study COMPLETED	26	26
Overall Study NOT COMPLETED	18	16

Reasons for withdrawal

Measure	Surgisis® AFP Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.	Flap Flap: Advancement flap surgery is performed; no anal fistula plug is placed
Overall Study Fistula draining at 6 months	2	4
Overall Study Lost to Follow-up	9	5
Overall Study Technical failure	0	1
Overall Study Withdrawal by Subject	1	1
Overall Study Persistence or recurrence of fistula	5	2
Overall Study Patients were not treated	1	3

Baseline Characteristics

A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas

Baseline characteristics by cohort

Measure	Surgisis® AFP n=43 Participants Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.	Flap n=39 Participants Flap: Advancement flap surgery is performed; no anal fistula plug is placed	Total n=82 Participants Total of all reporting groups
Age, Continuous	45.1 years STANDARD_DEVIATION 13.2 • n=5 Participants	49.4 years STANDARD_DEVIATION 13.1 • n=7 Participants	47.2 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	23 Participants n=7 Participants	56 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Patients that were lost to follow-up, withdrew, or not treated were not included in the analysis. In the Surgisis arm, there were 9 patients lost to follow-up, 1 patient withdrew, and 1 patient not treated; in the Flap arm, there were 5 patients lost to follow-up, 1 patient withdrew, and 3 patients not treated.

Healing was defined as "closure of external opening with absence of abscess, drainage and pain."

Outcome measures

Measure	Surgisis® AFP n=33 Participants Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.	Flap n=33 Participants Flap: Advancement flap surgery is performed; no anal fistula plug is placed
Healing Success	22 participants	25 participants

Adverse Events

Surgisis® AFP

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Flap

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Surgisis® AFP n=43 participants at risk Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.	Flap n=39 participants at risk Flap: Advancement flap surgery is performed; no anal fistula plug is placed
Skin and subcutaneous tissue disorders Induration / Redness / Swelling Involving External Opening	2.3% 1/43 • Number of events 1	0.00% 0/39
Skin and subcutaneous tissue disorders Fistula Tract Re-Opened After Closure had been Documented	0.00% 0/43	2.6% 1/39 • Number of events 1
Skin and subcutaneous tissue disorders Newly apparent fistula opening	0.00% 0/43	2.6% 1/39 • Number of events 1

Other adverse events

Measure	Surgisis® AFP n=43 participants at risk Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.	Flap n=39 participants at risk Flap: Advancement flap surgery is performed; no anal fistula plug is placed
Skin and subcutaneous tissue disorders Fistula tract re-opened after closure had been documented	9.3% 4/43 • Number of events 4	0.00% 0/39
Skin and subcutaneous tissue disorders Induration / Redness / Swelling involving external opening	2.3% 1/43 • Number of events 1	5.1% 2/39 • Number of events 2
Infections and infestations Infection / Abscess involving fistula	7.0% 3/43 • Number of events 3	7.7% 3/39 • Number of events 5
Surgical and medical procedures Plug fell out or flap failed	0.00% 0/43	5.1% 2/39 • Number of events 2

Additional Information

Jason Hodde, Clinical Affairs Manager

Cook Biotech Incorporated

Phone: 765-497-3355

Email: jhodde@cookbiotech.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60