Seprafilm® adhesion barrier: (1) a review of preclinical, animal, and human investigational studies

Table 1 Investigational clinical publications and calculated effect size

Reference	N	Therapeutic area	Favorable Seprafilm outcome	Effect size^a	Reported p value
van der Linden. [76]	19	Cardiac	Median retrosternal adhesions	Cannot be calculated, only median and range reported	NS
Koyuncu et al. [78]	23	Vascular	Internal jugular vein function	n/a	NS
Tsapanos et al. [75]	150	Gynecologic	Incidence of adhesions	2.9	Not reported
Tsapanos et al. [75]	150	Intrauterine surgery	Pregnancies	4.8	Not reported
Sanders et al. [77]	249	Neurologic	15 year old historical control group
			Successful primary scalenectomy	0.9	0.938
			Successful primary scalenectomy/1st rib resection	0.7	0.634
			Successful reoperation: neurolysis	1.3	0.760
			Successful reoperation: scalenectomy and neurolysis	1.6	0.811
Icinose et al. [84]	n/a	Neurologic	No control group or efficacy	n/a	n/a
Assaf et al. [80]	4	Opthalmic	No control group or efficacy	n/a	n/a
Taban et al. [81]	4	Opthalmic	No control group or efficacy	n/a	n/a
Shibata et al. [82]	1	Opthalmic	No control group	n/a	n/a
Filler et al. [79]	239	Orthopedic	No safety, efficacy or control	n/a	n/a
Caylan et al. [83]	21	Otologic	No control group	n/a	n/a

^aFor continuous outcomes, effect size is the (control group mean–the Seprafilm mean) divided by the pooled standard deviation for the two groups [ES = (M1−M2)/pooled SD], and for binomial outcomes, effect size is the odds ratio or the ratio of the odds of a success for the Seprafilm group to the odds of a success for the control group [ES = (ad)/(bc)]