Prospective clinical trial of SprayGel as a barrier to adhesion formation: an interim analysis.
OBJECTIVE
To evaluate SprayGel, a new sprayable adhesion barrier developed for laparoscopic and open pelvic and abdominal surgical procedures.


METHODS
Prospective, randomized, controlled, multicenter trial (Canadian Task Force classification I).


METHODS
University clinic and private clinic.


METHODS
Forty-five women, 24 randomized to treatment and 21 to control group.


METHODS
Open or laparoscopic myomectomy with and without application of SprayGel, followed by second-look laparoscopy (SLL) to evaluate postoperative adhesions.


RESULTS
Application of SprayGel was fast and easy. On average, 10 weeks after surgery, 18 treated patients (75%) and 13 (61.9%) controls had SLL. That procedure showed 5 (27.8%) of 18 treatment patients to be adhesion free versus 1 (7.7%) of 13 controls (p = 0.163). Patients randomized to SprayGel were 3.6 times more likely to be adhesion free than controls. Mean tenacity scores were significantly lower than in controls (0.5 vs. 1.7), a difference of 0.9 (95% CI 0.3, 1.5, p = 0.003) or 47% (95% CI 17%, 77%) less. Mean adhesion area was reduced in the treatment group (4.1 vs. 5.6) but not significant (p = 0.6747, 95% CI-5.4, 8.4). No adverse events regarding application of SprayGel were seen.


CONCLUSIONS
SprayGel was effective in reducing postoperative adhesion severity, and showed a trend toward reducing frequency and extent of adhesions after laparoscopic and open myomectomy. Further studies are necessary to confirm the promising results of this interim analysis.
Department of Obstetrics and Gynecology, Christian-Albrechts-University of Kiel, Kiel, Germany.
L
L
Mettler
A
A
Audebert
E
E
Lehmann-Willenbrock
K
K
Schive
V R
VR
Jacobs
D000269:Adhesives; D000328:Adult; D000336:Aerosols; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D020100:Hydrogels; D010535:Laparoscopy; D007889:Leiomyoma / Q000601:surgery*; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D013997:Time Factors; D000267:Tissue Adhesions / Q000517:prevention & control*; D014594:Uterine Neoplasms / Q000601:surgery*
D000269:Adhesives; D000336:Aerosols; D020100:Hydrogels