Description:
INTERCEED* (TC7) Absorbable Adhesion Barrier (Oxidized Regenerated Cellulose) is a sterile absorbable off-white knitted fabric prepared by the controlled oxidation of regenerated cellulose. It is stable and should be stored below 30°C (86°F). Actions:
INTERCEED Barrier reduces adhesion formation in gynecologic pelvic surgery by being applied dry to traumatized surfaces after meticulous hemostasis consistent with microsurgical principles to physically separate apposing tissue surfaces during theperiod of reperitonealization. When used as directed, INTERCEED Barrier is easy to apply and is absorbed from the site of implantation within four weeks. Absorption rate depends upon several factors including the amount used and implantation site. INTERCEED Barrier is chemically composed of oxidized regenerated cellulose which has been shown not to enhance bacterial growth.1
Indications:
INTERCEED Barrier is indicated as an adjuvant in gynecologic pelvic surgery for reducing the incidence of postoperative pelvic adhesions after meticulous hemostasis is achieved consistent with microsurgical principles. The safety and effectiveness of the device for reducing the incidence of postoperative pelvic adhesions in other than gynecologic microsurgical procedures have not been established through clinical studies.
Contraindications:
The use of INTERCEED* (TC7) Absorbable Adhesion Barrier is contraindicated in the presence of frank infection. INTERCEED Barrier is not indicated as a hemostatic agent. Appropriate means of achieving hemostasis must be employed.
Warnings:
INTERCEED Barrier must not be used in cases in which complete hemostasis has not been established. Postsurgical adhesions may occur in the presence of INTERCEED Barrier if meticulous hemostasis is not achieved.
INTERCEED Barrier is supplied sterile. As the material is not compatible with autoclaving or ethylene oxide sterilization, INTERCEED Barrier must not be resterilized. Foreign body reactions may occur in some patients. Interactions between INTERCEED Barrier and drugs used at the surgical site may occur. Pathologists examining sites of INTERCEED Barrier placement should be made aware of its usage and of the normal cellular response to INTERCEED Barrier2 to facilitate proper evaluation of specimens3. As with all foreign substances, INTERCEED Barrier should not be placed in a contaminated surgical site. The performance of INTERCEED Barrier at such a site has not been determined.
Precautions:
The safety and effectiveness of using INTERCEED Barrier in combination with other adhesion prevention treatments have not been clinically established.
Ectopic pregnancies have been associated with fertility surgery of the female reproductive tract. No adequate and well-controlled studies have been conducted in women who have become pregnant within the first month after exposure to INTERCEED Barrier. No data exist to establish the effect, if any, of INTERCEED Barrier on the occurrence of ectopic pregnancies. No teratogenic studies have been performed. Therefore, an avoidance of conception should be considered during the first complete menstrual cycle after use of INTERCEED Barrier.
Use only a single layer of INTERCEED Barrier, since multiple layers, packing or folding, will not enhance the adhesion barrier characteristics and may interfere with the absorption rate of INTERCEED Barrier. Care should be exercised in applying INTERCEED Barrier to a pelvic organ not to constrict or restrict it.
Adverse Reactions:
The type and frequency of adverse events reported are consistent with events typically seen following surgery.
Postsurgical adhesions may occur in the presence of INTERCEED Barrier, if meticulous hemostasis is not achieved.
Directions for use:
1. To minimize the formation of postoperative adhesions and to optimize the performance of INTERCEED Barrier, the following surgical techniques, as appropriate, are recommended: use of magnification, use of fine caliber microsurgical instruments, use of fine suture material of low tissue reactivity, achievement of meticulous hemostasis, minimization of tissue handling, prevention of desiccation of tissues, avoidance of introduction of foreign bodies, such as talc, in the operative field and precise reapproximation of tissue planes.4,5,6
2. Complete hemostasis must be achieved before application.
3. Remove all irrigation fluid and instillates from the peritoneal cavity. If Trendelenburg positioning is used, place patient in Reverse Trendelenburg position to remove as much of the irrigation fluid as possible from the cul-de-sac.
4. After complete hemostasis, the following steps are recommended in applying INTERCEED Barrier:
a...Cut pieces of INTERCEED Barrier to desired size, which should be sufficient to completely cover the area at risk.
b...Apply INTERCEED Barrier dry and in only a single layer. Do not fold, pack or apply multiple layers. Since INTERCEED Barrier adheres well to serosal tissue, it is not necessary to suture in place. Moistening INTERCEED Barrier with 1 to 2 ml of irrigating solution after positioning will further ensure adherence and conformance of INTERCEED Barrier to the application site. If moistening is desirable, this should be done 1) only after INTERCEED Barrier is placed on the deperitonealized serosal area and 2) cautiously to keep the fabric from floating off the surface. If the latter occurs, the piece of INTERCEED Barrier should be discarded and a new piece used.
c...Hold INTERCEED Barrier in place at site of application to ensure adherence.
d...INTERCEED Barrier should be applied just before closure of the surgical area in order to minimize possible dislodging during the remainder of the surgical procedure.
e...Assess the site after INTERCEED Barrier application for discoloration of the device. INTERCEED Barrier that is dark brown or black indicates incomplete hemostasis. If discoloration occurs, it will occur within 1 to 2 minutes following application of INTERCEED Barrier. This will render the product ineffective as an adhesion barrier. Should this discoloration occur, remove INTERCEED Barrier and achieve hemostasis. Apply new piece of INTERCEED Barrier as specified above. REFER TO WARNINGS.
How Supplied:
INTERCEED Barrier is available in two sizes - 1 1/2 x 2 inches (3.8 cm x 5.1 cm) and 3 x 4 inches (7.6 cm x 10.2 cm) in sterile foil envelopes.
Caution:
Federal law restricts this device to sale, distribution or use by or on the order of a physician.
Clinical Studies: A multicenter clinical investigation was conducted in gynecology patients with adhesions on both sidewalls of the pelvis.7 This allowed each patient to serve as her own control. The study employed a blinded randomization as to which sidewall was treated, followed by an "open label" treatment with INTERCEED Barrier. INTERCEED Barrier was applied to the denuded parietal peritoneum of the pelvic sidewall only. The incidence of adhesions which formed after adhesiolysis and reconstructive pelvic surgery was determined by a "second-look" laparoscopy. INTERCEED Barrier significantly reduced the incidence of adhesions between the ovary and pelvic sidewall.
Use and Application for Laparotomy
1. Apply at the end of the procedure
2. Complete hemostasis must be achieved before application
3. Remove all irrigation fluid and instillates from the peritoneal cavity
a...If Trendelenburg positioning is used then place patient in Reverse Trendelenburg to remove as much of the irrigation fluid as possible from the cul-de-sac
4. Cut to sufficient size to allow 3-5 mm margin around area at risk
5. Apply INTERCEED (TC7) Absorbable Adhesion Barrier just prior to closure
a......If INTERCEED Barrier becomes black upon application, then blood is present, and will render the product ineffective as an adhesion barrier
b......Remove INTERCEED Barrier and achieve hemostasis
c......Apply new piece of INTERCEED Barrier as specified below
6. Apply INTERCEED Barrier dry and in a single layer
a......If more than one piece is required allow the pieces to overlap by a margin of 3-5 mm to ensure contiguous coverage of the area at risk
7. No sutures needed
8. Moisten with up to 2 ml per 3" x 4" piece