Evaluation of SprayShield™ Adhesion Barrier in a single center: randomized controlled study in 15 women undergoing reconstructive surgery after laparoscopic myomectomy.
OBJECTIVE
The objective of this study was to evaluate the safety and efficacy of SprayShield™ Adhesion Barrier in preventing and/or reducing postoperative adhesion during gynecological surgery.


METHODS
This was a prospective, controlled, blinded, and randomized study. Patient blinding was performed intraoperatively. Subjects were randomly assigned to the SprayShield™ or the control group in a 2:1 ratio.


METHODS
The study was conducted at the Clinic of Gynaecology and Obstetrics, at the University Hospital for Gynecology in Germany.


METHODS
Fifteen patients participated in this study; nine patients were assigned to the SprayShield™ and six patients to the control group.


METHODS
During first operation (FLL) in the SprayShield™ group, the agent was applied to all myomectomy suture lines. Patients in the control group did not receive any anti-adhesion treatment, only good surgical practice. A second-look laparoscopy (SLL) was performed 8-12 weeks after myomectomy to evaluate adhesion formation.


METHODS
Main outcome measures were incidence, severity, and extent of uterine adhesions.


RESULTS
No significant differences were found between the two study groups.


CONCLUSIONS
SprayShield™ is easy to use. No serious adverse event related to SprayShield™ was observed. Efficacy data are inconclusive regarding the performance of SprayShield™. Further studies are needed to better understand this performance.
Klinik für Minimal Invasive Chirurgie, 14129, Berlin-Zehlendorf, Germany.
Garri
G
Tchartchian
Andreas
A
Hackethal
Anja
A
Herrmann
Bernd
B
Bojahr
Christian
C
Wallwiener
Ralf
R
Ohlinger
Andreas D
AD
Ebert
Rudy Leon
RL
De Wilde
D020341:Absorbable Implants; D000328:Adult; D047070:Bandages, Hydrocolloid; D005260:Female; D006801:Humans; D010535:Laparoscopy; D011446:Prospective Studies; D024162:Second-Look Surgery; D016037:Single-Blind Method; D000267:Tissue Adhesions / Q000517:prevention & control; D063186:Uterine Myomectomy / Q000379:methods*