Effect of local gentamicin-collagen on perineal wound complications and cancer recurrence after abdominoperineal resection: a multicentre randomized controlled trial.
OBJECTIVE
Perineal wound sepsis is a common problem after abdominoperineal resection of the rectum (APR), with a reported incidence of 10-15% in previously non-irradiated patients, 20-30% in patients given preoperative radiation and 50% among patients submitted to preoperative radiation combined with chemotherapy. The local application of gentamicin-collagen was evaluated to determine whether its use in the perineal wound reduced risk complications and had an effect on cancer recurrence.


METHODS
In this prospective multicentre (seven hospitals) randomized controlled trial, 102 patients undergoing APR due to cancer or benign disease were randomized into two groups including surgery with gentamicin-collagen (GS+, n = 52) or surgery without gentamicin-collagen (GS-, n = 50). Patients were followed at 7, 30 and 90 days and at 1 and 5 years.


RESULTS
There were no statistically significant differences between the two groups regarding perineal wound complications, infectious or non-infectious, or cancer recurrence.


CONCLUSIONS
There was no statistically significant effect on perineal wound complications or cancer recurrence following the local administration of gentamicin-collagen during APR.
Department of Surgical Science, Uppsala University, Uppsala, Sweden. asa.collin@akademiska.se
Å
Å
Collin
U-M
UM
Gustafsson
K
K
Smedh
L
L
Påhlman
W
W
Graf
J
J
Folkesson
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D003094:Collagen / Q000008:administration & dosage*; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D005839:Gentamicins / Q000008:administration & dosage*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology / Q000517:prevention & control*; D010502:Perineum / Q000601:surgery; D010533:Peritoneal Lavage / Q000379:methods*; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000601:surgery*; D013530:Surgical Wound Infection / Q000188:drug therapy* / Q000453:epidemiology / Q000209:etiology; D013548:Sweden / Q000453:epidemiology; D014945:Wound Healing
D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D005839:Gentamicins; D003094:Collagen