Introduction
Method
Level | Definition of evidence |
---|---|
1 | Randomised, controlled trial (RCT) that demonstrated a statistically significant difference in at least one important outcome |
OR | |
If the difference is not statistically significant, an RCT of adequate sample size to exclude a 25% difference in relative risk with 80% power, given the observed results | |
2 | RCT that does not meet level 1 criteria |
3 | Non-randomized trial with contemporaneous controls selected by some systematic method (i.e. not selected by perceived suitability for one of the treatment options for individual patients) |
OR | |
Subgroup analysis of a randomised trial | |
4 | Before-after study or case series (of ≥10 patients) with historical controls or controls drawn from other studies |
5 | Case series (of ≥10 patients) without controls |
6 | Case reports (of <10 patients) |
Clinical experience
Author and evidence grading | Product | Population | Number of subjects and treatment groups | Results |
---|---|---|---|---|
Rutten (1997)[25] Level 1 | Collatamp®* Implant cut into three longitudinal strips. The fascia was closed and the implant placed directly upon the closed fascia directly adjacent to the surgical wound. The skin was closed with a double layer of resorbable sutures | Patients stratified by type of procedure Colonic resection Reversal of Hartmann procedure Abdominoperineal resection (APR) Subtotal colectomy Low anterior resection | n = 221 total patients n = 107 gentamicin collagen implant plus ceftriaxone + metronidazole IV or gentamicin + metronidazole IV (Group I) n = 114 ceftriaxone + metronidazole IV or gentamicin + metronidazole IV (Group II) | Wound infections: Group I: 5.6% (6/107) vs. Group II: 18.4% (21/114) (P < 0.01) LOS: Group I: 13.8 days vs. Group II: 16.3 days (P = 0.015) Microbiology: Bacterial species were cultured from n = 3/107 in group I and n = 8/114 in group II |
Grüssner (2001) [27] Level 1 | Septocoll®
Three implants 5 × 8 cm evenly inserted into the sacral cavity at one level with the remnants of the levator ani muscle | Patients undergoing abdominoperineal resection (APR) for low rectal carcinoma | n = 97 total patients n = 49 gentamicin collagen implant plus cefazoline + metronidazole plus sacral drainage (Group I) n = 48 cefazoline + metronidazole plus sacral drainage (Group II) | Wound infections: Group I: 6.1% (3/49) vs. Group II: 20.83% (10/48) (P < 0.05) Wound healing: Primary perineal wound healing—Group I: 88% (43/49) vs. Group II: 75% (36/48) (P = 0.12) Secondary perineal wound healing with infection—Group I: 6% (3/49) vs. Group II : 21% (10/48) (P < 0.05) Microbiology: Bacteriologic efficacy in Group I: 83.7% (41/49) vs. Group II: 60.4% (29/48) (P = 0.013) |
Nowacki (2005) [26] Level 1 | Collatamp®
One 10 × 10 cm implant placed in the presacral area below the peritoneal reflection. When anterior resection was performed, the implant was wrapped around the anastomosis | Patients undergoing Anterior resection Low anterior resection Abdominoperineal resection (APR) Hartmann procedure | n = 229 randomised n = 113 gentamicin collagen implant plus metronidazole + cefuroxamine IV (Group I) n = 116 metronidazole + cefuroxamine IV (Group II) | Early post-operative complications (30 days): Total complications—Group I: 20.7% (22/106) vs. Group II: 37.5% (42/112) (P = 0.0441) Surgery > 3 h—Group I: 19.2% (15/78) vs. Group II: 40.8% (31/76) (P = 0.0314) Intraoperative bowel perforation/contamination of peritoneal cavity—Group I: 20% (3/15) vs. Group II: 57.9% (11/19) (P = 0.01) Cancer recurrence: Local recurrence/or metastasis at 36 months—Group I: 14.4% vs. Group II: 32.3% (P = 0.03) Rate of local recurrence similar in both groups Distant metastasis—Group I: 10.3% vs Group II: 28.1% (P = 0.0095) Survival: 3-year survival—Group I: 88.66% vs. Group II: 73.96% |
de Bruin (2008) [28] Level 3 | Collatamp®
Three implants inserted into the sacral wound cavity at one level with the remnants of the levator ani muscle | Consecutive series of patients undergoing abdominoperineal resection (APR) for rectal cancer after short-course radiotherapy | n = 40 total n = 19 gentamicin collagen implant plus amoxicillin + clavulanate IV plus sacral drainage (Group I) n = 21 amoxicillin + clavulanate IV plus sacral drainage (Group II) | Wound infections: Total wound infection (deep & superficial)—Group I: 16% (3/19) vs. Group II: 57% (12/21) (P = 0.01) Deep wound infection—Group I: 5% (1/19) vs Group II: 29% (6/21) (P = 0.05) Superficial wound infection—Group I: 11% (2/19) vs. Group II: 29% (6/21) (n.s) Wound healing: Primary wound healing—Group I: 84% (16/19) vs. Group II: 43% (9/21) (P < 0.01) LOS: Group I: 15 days vs. Group II: 25 days (P = 0.04) |
Gomez (1999) [29] Level 1 | Collatamp®
One 10 × 10 cm implant placed in the wound above the aponeurosis and wound sutured | Patients with ‘dirty’ abdominal wounds derived from lower GI tract surgery e.g. colon perforation, acute appendicitis or gallbladder perforation | n = 66 total patients n = 34 gentamicin collagen implant plus metronidazole IV for 7 days plus primary closure (Group I) n = 32 open wound cleaned daily with povidone solution plus metronidazole + gentamicin IV for 7 days. The wound was closed after 3 days if no infection (Group II) | Wound infections: Group I: 8.82% (3/34) vs. Group II: 43.75% (14/32) (P < 0.001) Wound healing: Group I: 10.31 days vs. Group II: 15.20 days (P < 0.001) LOS: Group I: 5.45 days vs. Group II: 7 days Microbiology: Group I had monomicrobial wound infections whereas Group II had multimicrobial wound infections |
Haase (2005) [30] Level 2 | Collatamp®
One implant placed subcutaneously and wound sutured | Patients undergoing loop-ileostomy closure | n = 80 total patients n = 40 gentamicin collagen implant (Group I) n = 40 collagen implant without gentamicin (placebo) (Group II) | Wound infections: There was no statistical difference in the rate of wound infections between the two groups The infection rate in both groups was much lower than previously reported with this type of procedure Surgical complications: There was no statistical difference in the rate of surgical complications between the two groups |
Vogel (1992) [34] Level 1 | Collatamp®
Wound covered with 1–4 implants according to the size of the excision and the wound closed with 1–2 layers of sutures | Patients undergoing surgical excision for pilonidal sinus | n = 80 total patients n = 40 gentamicin collagen implant plus extensive excision of pilonidal sinus (Group I) n = 40 extensive excision of pilonidal sinus (Group II) | Wound healing: Primary healing rate—Group I: 87.5% vs. Group II: 35% (P < 0.001) Secondary wound healing—Group I: 12.5% vs. Group II: 62.5% (P < 0.001) Abscesses led to secondary wound healing in 7.5% (3/40) in Group I vs. 50% (20/40) in Group II (P < 0.001) On follow-up examination at 1 year, no recurrence had occurred in either group |
Holzer (2003) [35] Level 1 | Septocoll®
One 5 × 8 cm implant implanted in the wound cavity. The wound was closed with 1–2 layers of sutures after placement of a drain | Patients undergoing surgical excision for pilonidal sinus | n = 103 total patients n = 51 gentamicin collagen implant plus primary closure (Group I) n = 52 open treatment (Group II) | Wound healing: Time to complete wound healing—Group I: 17 days vs Group II: 68 days (P = 0.0001) LOS: Group I: 9 (1–24) days vs Group II: 10 (1–13) days One recurrent pilonidal sinus was seen in group I and none in group II in the 26-week follow-up period |
Rao (2009) [36] Level 1 | Collatamp®
One to two implants were inserted depending on size of cavity. The wound was closed with two layers of sutures | Patients undergoing surgical excision for pilonidal sinus | n = 60 total patients n = 30 gentamicin collagen implant plus primary closure (Group I) n = 30 open treatment (Group II) | Wound healing: Percentage of patients healed after 4 weeks—Group I: 90% vs. Group II: 13% (P < 0.001) Mean time to wound healing—Group I: 10 days vs. Group II: 50 days (P < 0.001). LOS: There was no difference seen between the two groups in length of hospital stay |