PDS vs Polyamide for Midline Abdominal Closure - Full Text View

Purpose

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.

Condition	Intervention
Laparotomy	Device: Suture for midline abdominal closure

ChemIDplus related topics:

Polydioxanone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Is Polydioxanone 'THE' Suture of Choice for Midline Abdominal Closure? Results of a Prospective Randomized Clinical Trial

Further study details as provided by Christian Medical College and Hospital, Ludhiana, India:

Primary Outcome Measures:

Wound Complications associated with suture material used for closure- Wound Dehiscence, Wound Infection, Incisional Hernia, Suture Sinus, Scar Pain [ Time Frame: 2 years ]

Secondary Outcome Measures:

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 [ Time Frame: 2 years ]

Enrollment:	64
Study Start Date:	October 2004
Study Completion Date:	April 2006

Arms	Assigned Interventions
1: Active Comparator Surgical Patient undergoing midline laparotomy closure	Device: Suture for midline abdominal closure closure with Polyamide or Polydioxanone

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.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514566

Locations


India, Punjab
	Christian Medical College and Hospital
	Ludhiana, Punjab, India, 141008

Sponsors and Collaborators

Christian Medical College and Hospital, Ludhiana, India

Investigators


Study Chair:	Rajeev Kapoor, MS(Gen Surg)	Christian Medical College and Hospital, Ludhiana, India

More Information

Study ID Numbers:	ChristianMCLudhiana
First Received:	August 8, 2007
Last Updated:	August 8, 2007
ClinicalTrials.gov Identifier:	NCT00514566
Health Authority:	India: Institutional Review Board

Keywords provided by Christian Medical College and Hospital, Ludhiana, India:

Polyamide

Polydioxanone

Midline

Abdominal

Closure

ClinicalTrials.gov processed this record on August 29, 2008

Sponsored by:	Christian Medical College and Hospital, Ludhiana, India
Information provided by:	Christian Medical College and Hospital, Ludhiana, India
ClinicalTrials.gov Identifier:	NCT00514566