Laparotomy
Conditions
Keywords
Polyamide, Polydioxanone, Midline, Abdominal, Closure
Brief summary
Within the last decade the customary trend of using non absorbable sutures has changed, with numerous studies and meta-analyses advocating the use of slowly absorbable sutures, claiming comparable wound strength with significantly lower incidence of wound complications. It was the objective of this randomized clinical trial to compare two universally accepted suture materials, the non-absorbable Nylon and the slowly absorbable Polydioxanone for midline abdominal closure in the Indian context.
Detailed description
64 patients undergoing midline laparotomy were allocated, using block randomization, to mass closure of the abdominal wall with continuous polyamide (34 patients) or continuous polydioxanone (30 patients). There was an alarmingly higher incidence of wound dehiscence in the PDS group requiring secondary suturing (Nylon 0; PDS 5). Mid-way through the trial, an interim analysis was performed which revealed an unacceptably high incidence of wound dehiscence in the PDS group. This necessitated a premature curtailment of the study. There was, however, a statistically significantly higher incidence of scar pain in the Nylon group (Nylon 9; PDS 1). There is a need for a study with larger series, and PDS as a choice of suture for midline wound closure cannot be recommended.
Interventions
DEVICESuture for midline abdominal closure
closure with Polyamide or Polydioxanone
Sponsors
Christian Medical College and Hospital, Ludhiana, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients above 12 years of age undergoing midline abdominal fascial closure using a continuous technique in the Department of Surgery, Christian Medical College and Hospital
Exclusion criteria
* All patients under 12 years of age * Gynaecological operations * Abdominal wall hernia repair
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound Complications associated with suture material used for closure- Wound Dehiscence, Wound Infection, Incisional Hernia, Suture Sinus, Scar Pain | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Factors independent of suture materials responsible for wound complications such as age, gender, type of surgery, degree of contamination, surgeon, and presence of a stoma | 2 years |
Countries
India
Outcome results
None listed