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Prospective randomized controlled study about the adhesion prevention safety and effects for the general surgery using the absorbable adhesion barrier (INTERCEED) made of oxidized regenerated cellulose.

ABSTRACT: Interventions: A piece of dried interceed which is 3-5mm larger than the surgery site will be placed to prevent adhesion just before abdominal closure of the laparoscopic surgery. Normal laparoscopic surgery (without interceed) Primary outcome(s): Frequency of serious adverse event within 30 days from surgery. Study Design: Parallel Randomized

DISEASE(S): Colorectal Cancer

PROVIDER: 2625703 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:In this experimental study, we aimed to examine the ability of absorbable oxidised regenerated cellulose (Interceed, TC-7, Johnson & Johnson, USA) to inhibit the formation of peritendinous fibrotic adhesions after tendon repair in rats. Both Achilles tendons of 23 female Wistar-Albino rats weighing between 350 and 450 grams were cut and repaired. On the right side, Interceed absorbable adhesion barriers were wrapped around the repaired tendon (group I). On the left, the same procedures were applied except for the Interceed wrapping and these were grouped as control (group II). Animals were sacrificed at postoperative day 28 and macroscopic and histological examination was performed. All the animals survived and no tendon rupture was observed. No wound dehiscence, wound infection or exposure of repaired tendons occurred. Macroscopically, there were three (13.1%) tendons without adhesion formation and 20 (86.9%) tendons with inferior adhesion formation in group I; on the other hand, there were 16 tendons (69.5%) with medium grade adhesion formation and seven tendons (30.5%) with severe peritendinous adhesion formation in group II (control group) (p<0.05). Histologically, adhesion formation was absent in 11 tendons (47.8%) and slight in 12 tendons (52.2%) in group I; while in group II, it was slight in two (8.6%), moderate in 15 (65.2%) and severe in six tendons (26.2%) (p<0.05). Sixteen (69.5%) of 23 tendons in group I and 11 (47.8%) of 23 tendons in group II showed no inflammatory reaction (p<0.05). Nineteen (82.6%) tendons in group I and only one tendon in group II showed excellent to good tendon healing (p=0.00). According to our results, we feel that Interceed may have an intraoperative role to play in the reduction of adhesions after surgical tendon repair. This study suggests that absorbable oxidised regenerated cellulose merits further evaluation as a potential treatment to inhibit the formation of peritendinous adhesions. Rigorous and extensive controlled trials should be undertaken on patients undergoing tendon repair with or without this barrier.

Dataset Information

Prospective randomized controlled study about the adhesion prevention safety and effects for the general surgery using the absorbable adhesion barrier (INTERCEED) made of oxidized regenerated cellulose.

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