PDS vs Polyamide for Midline Abdominal Closure (PPMAC)

Christian Medical College and Hospital, Ludhiana, India

Status

Terminated

Conditions

Laparotomy

Treatments

Device: Suture for midline abdominal closure

Study type

Interventional

Funder types

Other

Identifiers

NCT00514566

ChristianMCLudhiana

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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