Reduction of postoperative adhesions after laparoscopic gynecological surgery with Oxiplex/AP Gel: a pilot study.
OBJECTIVE
To determine whether Oxiplex/AP Gel (FzioMed, San Luis Obispo, CA) was safe and preliminarily effective in reducing postsurgical adhesions after adnexal surgery by laparoscopy.


METHODS
Prospective, multicenter, double-blind, randomized, U.S. Food and Drug Administration-monitored feasibility study.


METHODS
University and private clinics.


METHODS
Patients undergoing laparoscopic surgery with pelvic adhesions, tubal occlusion, endometriosis, and/or dermoids were randomized to receive Oxiplex/AP Gel or no further treatment after surgery.


METHODS
A blinded, parallel-group design was conducted at six centers. Patients (aged 18-46 years) underwent laparoscopic surgery, with second-look surgery 6-10 weeks later. Surgeries were videotaped. Oxiplex/AP Gel was used to cover adnexa and adjacent tissue.


METHODS
Blinded reviews of videotapes were quantitated with the American Fertility Society adhesion score (AFS score).


RESULTS
In 18 treatment patients, surgery was performed on 29 adnexa. Application of Oxiplex/AP Gel required approximately 90 seconds. In 10 control patients, surgery was performed on 18 adnexa. The mean baseline AFS score for each group was 8.0. At second look, treated adnexa had the same score (8.1), whereas in control adnexa the score increased (from 8.0 to 11.6). Thirty-four percent of treated adnexa increased in adhesion score, in contrast to 67% of control adnexa. There were no device-related adverse events.


CONCLUSIONS
In this pilot study, Oxiplex/AP Gel was safe, easy to use with laparoscopy, and produced a reduction in the increase of adnexal adhesion scores.
Young
Phil
P
IGO Medical Group, San Diego, California, USA.
Johns
Alan
A
Templeman
Claire
C
Witz
Craig
C
Webster
Bobby
B
Ferland
Roger
R
Diamond
Michael P
MP
Block
Kathleen
K
diZerega
Gere
G
D000293:Adolescent; D000328:Adult; D002482:Cellulose / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects*; D008875:Middle Aged; D010865:Pilot Projects; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies; D018709:Statistics, Nonparametric; D000267:Tissue Adhesions / Q000188:drug therapy* / Q000473:pathology
D005782:Gels; C406630:Oxiplex; D011092:Polyethylene Glycols; D002482:Cellulose